Bleeding In Pediatric Patients Research Articles

Clinical assessment of small bowel capsule endoscopy in pediatric patients.

Small bowel capsule endoscopy is a first-line examination method for small bowel diseases, which can find small intestinal lumen and mucosal lesions. We retrospectively assessed patients who underwent small bowel capsule endoscopy between September 2020 and May 2023 to examine their clinical and small bowel capsule endoscopic data, aiming to provide insights into the application of this technique in pediatric patients with small intestinal diseases. All instances of capsule retention were successfully resolved through enteroscopy. Of the 1140 children who completed the capsule endoscopy, 97.46% (1111/1140) underwent a comprehensive examination of the entire small intestine without experiencing any discomfort. Capsule endoscopy yielded abnormal findings in 672 cases, with a positive detection rate of 58.95%. Among the positive results, intestinal mucosal inflammatory lesions were the most prevalent, occurring in 292 cases (43.45%), followed by ulcerative or erosive lesions in 236 cases (35.12%), diverticulum in 54 cases (8.04%), and vascular lesions in 30 cases (4.46%). Lymphangiectasis was observed in 16 cases (2.38%). The distribution of positive lesions did not exhibit significant gender-based differences, but there were variations among different age groups. Among all children who completed the small bowel capsule endoscopy, the most frequently reported symptom was abdominal pain (815/1140 cases, 71.49%), followed by 130 cases (11.40%) of bloody stools or melena. Small bowel capsule endoscopy is well-tolerated and safe in children, carrying significant clinical importance for diagnosing abdominal pain and obscure gastrointestinal bleeding in pediatric patients.

Endoscopic variceal ligation combined with sclerotherapy for management of gastroesophageal variceal bleeding in pediatric patients: a single-center retrospective study.

Portal hypertension (PH) frequently gives rise to severe and life-threatening complications, including hemorrhage accompanied by the rupture of esophageal and gastric varices. In contrast to the guidelines for the management of PH in adults, the optimal endoscopic management of variceal bleeding for secondary prophylaxis in children remains unclear. The present study evaluated the efficacy and safety of endoscopic variceal ligation (EVL) and endoscopic sclerotherapy (EST) to control gastroesophageal variceal bleeding in children. This retrospective study included children with gastroesophageal variceal bleeding who underwent EST or EVL at Xinhua Hospital, Shanghai Jiaotong University School of Medicine, between February 2013 and March 2020. Short-term hemostasis rate and long-term rebleeding rate were evaluated. Adverse events related to the procedures, such as esophageal ulcer, esophageal stricture, abnormal embolization, pneumonia and perforation, were also recorded. EVL (n = 8) and EST (n = 13) were performed successfully in all pediatric patients diagnosed with moderate to severe esophageal varices concurrent with gastric varices. Hemostasis was achieved during episodes of upper gastrointestinal bleeding. The mean volume of each single aliquot of cyanoacrylate injected was 0.3 ± 0.1 ml (range: 0.1-0.5 ml). Varices were eradicated in six (75%) of the eight patients who underwent EVL after a median 2 (range: 1-4) procedures and a median time of 3.40 months (range: 1.10-13.33 months). Eleven (52.4%) of the 21 patients developed rebleeding events, with the mean duration of hemostasis being 11.1 ± 11.6 months (range 1.0-39.2 months). No treatment-related complications, for example, distal embolism, occurred except for abdominal pain in one patient (4.8%). EST, alone or in combination with EVL, is an effective and safe method of managing gastroesophageal variceal hemorrhage in children undergoing secondary prophylaxis.

Tranexamic Acid in Hip Reconstructions in Children with Cerebral Palsy: A Double-Blind Randomized Controlled Clinical Trial.

Surgical treatment is indicated for hip dislocation in patients with cerebral palsy (CP), but it requires care due to the state of nutrition and associated clinical comorbidities. The use of resources that minimize blood loss and the need for blood transfusions are essential to avoid complications. Tranexamic acid (TXA) has been highlighted for orthopedic surgeries to control intraoperative bleeding; however, there is a lack of large studies for its use in hip surgeries in patients with CP. This study aims to evaluate the efficacy and safety of tranexamic acid to reduce bleeding in pediatric patients with cerebral palsy undergoing surgical treatment for hip instability. A sample of 31 patients with CP who underwent surgical treatment for hip dislocation (hip adductor stretching, varization osteotomy of the proximal femur and acetabuloplasty using the Dega technique) was randomly divided into groups: control (n = 10) and TXA (n = 21). Preoperative and 24 h hemoglobin concentrations, the length of hospital stay (LHS), and intraoperative bleeding (IB) were analyzed. TXA significantly reduced the IB (p = 0.02). The variance in hemoglobin concentration was lower for the TXA group, but without statistical significance (p = 0.06). There was no difference in LHS. Also, no statistical difference was observed for the number of transfusions (p = 0.08). The findings provide evidence of the effectiveness of TXA in decreasing intraoperative bleeding and its safety for use in pediatric patients with cerebral palsy.

A Y-shape connection device for pediatric patients with an indwelling catheter (Dia = 8Fr) during urodynamic studies, especially for filling phase measurements: a single-center prospective study for safety and effectiveness.

This prospective study aimed to assess the effectiveness of a Y-shape connection device in reducing pain and bleeding in pediatric patients with indwelling catheters during urodynamic studies (UDS), while also obtaining effective results in the filling phase. A total of 45 pediatric patients with a mean age of 13 years were included, all of whom underwent both a UDS with the Y-shape connection device (Method A) and a standard UDS procedure (Method B). The Y-shape connection device demonstrated similar overall urodynamic parameters compared to the standard procedure, while also resulting in significantly less bleeding (P = 0.006) and lower VAS scores during (1.12 ± 0.58 vs. 3.88 ± 1.01, P = 0.001) and after (0.12 ± 0.08 vs 2.91 ± 0.89, P = 0.001) the procedure. No adverse events were reported at the 1-month follow-up. These findings suggest that the Y-shape connection device can effectively reduce pain and bleeding during and after UDS in pediatric patients with indwelling catheters (Dia = 8Fr), while also obtaining effective results in the filling phase. Therefore, this Y-shape connection device has a more significant value for children who require urodynamic studies and place more emphasis on filling phase parameters. ChiCTR2300068280.

Vitreous Hemorrhage in Pediatric Patients With X-Linked Retinoschisis: Characteristics and Outcomes.

To report the management and outcomes of vitreous hemorrhage in pediatric patients with X-linked retinoschisis (XLRS). Retrospective case series of pediatric patients with XLRS with vitreous hemorrhage between January 2000 and January 2022 at the Bascom Palmer Eye Institute. Nine patients (12 eyes) met inclusion criteria. The average age at presentation was 5.75 years and mean follow-up time was 6 years. All eyes (58.3%) that underwent fluorescein angiography exhibited peripheral capillary dropout. Six of 12 eyes (50%) were observed without intervention. Four of 12 eyes (33.3%) underwent intravitreal injection of bevacizumab and 2 (16.6%) underwent vitreoretinal surgery. Seven of 12 eyes (58.3%) had documented recurrence of vitreous hemorrhage during follow-up. All retinas were attached and had clear media at final follow-up. Fluorescein angiography is a helpful tool to evaluate the vascular phenotype in XLRS. Favorable anatomic outcomes were noted in this cohort, but recurrence of vitreous hemorrhage was common. [Ophthalmic Surg Lasers Imaging Retina 2023;54:513-518.].

Post-Tonsillectomy Hemorrhage in Pediatric Patients: Comparison of Age Groups and Surgical Techniques

Post-Tonsillectomy Hemorrhage in Pediatric Patients: Comparison of Age Groups and Surgical Techniques

PREDICTIVE FACTORS OF MORBIDITY ASSOCIATED WITH ESOPHAGEAL VARICEAL BLEEDING IN CHILDREN WITH PORTAL HYPERTENSION.

•Most data on the natural history of portal hypertension come from studies in adults. •The morbidity rate of upper gastrointestinal bleeding in children with portal hypertension tend to be underestimated. •This study showed the relevance of morbidity rates after variceal hemorrhage in pediatric patients, especially those with cirrhosis. •Patients with hemodynamic instability requiring blood transfusion or expansion on admission are at increased risk of complications secondary to upper gastrointestinal bleeding and should be closely monitored. Background - Most data on the natural history of portal hypertension come from studies in adults. The morbidity rate of upper gastrointestinal bleeding (UGIB) in children with portal hypertension has not been systematically characterized. Objective - To describe the morbidity and mortality of UGIB in pediatric patients with portal hypertension and identify predictive factors for the occurrence of its main complications. Methods - This retrospective study included pediatric patients with cirrhotic portal hypertension or with extrahepatic portal vein obstruction (EHPVO). Mortality and UGIB complications within a period of up to 6 weeks of the bleeding were investigated. To determine the predictive factors of morbidity, a multivariate analysis was performed using logistic regression; all results were considered significant at P<0.05. Results - A total of 86 patients (51.2% with EHPVO and 48.8% with cirrhosis) had 174 bleeding events. Ascites was the most common complication (43.1% of all cases), being more prevalent in patients with cirrhosis (P<0.001). Cirrhosis was a predictor of the occurrence of any morbidity (OR 20.3). The need for blood transfusion was predictor of at least one complication (OR 5.8), ascites (OR 7.2) and infections (OR 3.8) in the general group and at least one complication (OR 11.3) and ascites (OR 5.8) in cirrhotic patients. The need for expansion was a predictor of any morbidity (OR 4.6) and infections (OR 3.9) in the general group, in addition to being predictor of infection in cirrhotic patients (OR 5.4). There were no deaths from UGIB in the six weeks post-bleeding. Conclusion - The study showed the relevance of morbidity after UGIB in pediatric patients with portal hypertension, especially in those with cirrhosis. The patients with hemodynamic instability requiring blood transfusion or expansion on admission are at increased risk of complications related to upper gastrointestinal bleeding and should be closely monitored.

Comparative outcome of endovascular embolization with microsurgery in managing acute spontaneous cerebral hemorrhage in pediatric patients, an institutional experience.

A few previous studies have reported the role of embolization with curative intent in the treatment of the early phase of a spontaneous cerebral hemorrhage in pediatric patients, and its efficacy needs to be compared with surgery at the same time risk factors for hemorrhage following early embolization in such patients need to be evaluated. From a pool of 80 pediatric (< 18years) who had undergone treatment for ruptured AVM with hemorrhage at our center between July 2018 and July 2022, we identified 36 patients with spontaneous bleeding due to AVM. Out of which, 20 were treated solely by embolization (group 1), while the remaining patients were treated surgically (with and without adjuvant embolization) (group 2). Spetzler-Martin's grading of the lesion suggested seven lesions < 3 and 13 lesions ≥ 3 in the embolization group. Similarly, seven lesions were < 3 and nine ≥ 3 Spetzler-Martin grade in the surgery group. Incomplete embolization was associated with hemorrhage in two patients treated with curative intent and four patients treated with embolization as adjuvant in the surgery group (p = 0.01). On follow-up, 18 patients in the embolization group and 12 in the surgery group had Glasgow outcome scores ≥ 4 (p = 0.273). In the pediatric age group, incomplete embolization is the significant risk factor for hemorrhage in AVMs treated after a hemorrhagic stroke. Embolization with curative intent is as effective as surgery in treating such lesions as adjuvant embolization with careful patient selection.

Abstract 11530: Edoxaban For Pediatric Patients With Cardiac Diseases: A Randomized, Open Label, Multicenter Study

Introduction: Standard of care (SOC) anticoagulation for thromboembolism (TE) prevention in patients &lt;18 years old with cardiac disease includes low molecular weight heparins or vitamin K antagonists. Limited data exist comparing direct oral anticoagulants as edoxaban with conventional anticoagulants in this population. Hypothesis: Edoxaban is at least as safe as the current standard-of-care (low molecular weight heparins and/or vitamin K antagonists) with regard to the incidence of major and clinically relevant nonmajor bleeding in pediatric patients with cardiac diseases at risk of thromboembolism. Methods: We performed a phase 3, multinational, prospective, randomized, open-label, blinded-endpoint trial in patients &lt;18 years old with cardiac disease (ENNOBLE-ATE, NCT00687882). Children were randomized 2:1 to age- and weight-based oral edoxaban once-daily versus SOC for 3 months (main study). Randomization was stratified by concomitant use of aspirin and by underlying disease groups, as follow: history of Fontan procedure; Kawasaki disease; heart failure; other. Both groups continued in an extension with edoxaban through 1 year. The primary endpoint was adjudicated International Society on Thrombosis and Haemostasis defined clinically-relevant bleeding (CRB). The main secondary endpoint was a composite of symptomatic TE and asymptomatic intracardiac thrombosis. Results: We randomized 168 children from May 2018 to September 2021. The CRB event rates were similar between groups during the main period. One subject per group experienced a nonmajor CRB. Treatment-emergent adverse events occurred in 46.8% (51/109) with edoxaban and 41.4% (24/58) with SOC. One SOC subject experienced 2 TE events (DVT with PE). In 152 subjects continuing in the extension, one CRB event (0.7%; trauma related) and 4 TEs occurred (2.8%; 2 strokes and 2 coronary artery thromboses and/or myocardial infarctions). Conclusion: Bleeding and TE occurred rarely for both groups and during the extension,suggesting that edoxaban is safe and effective for TE prevention in this population. Once daily edoxaban may provide advantage for children considering difficulties with enoxaparin injections and food and drug interactions with warfarin.

Cavernous hemangioma of the small intestine diagnosed by capsule endoscopy in an 8-year-old girl

Cavernous hemangiomas of the small intestine are rare. Usually, early diagnosis is difficult because patients are often asymptomatic for a long period. In recent years, capsule endoscopy has been used to diagnose small-bowel lesions with small-intestinal bleeding in pediatric patients. Herein, we present a case of cavernous hemangioma of the small intestine diagnosed by wireless capsule endoscopy in an 8-year-old girl. To our knowledge, this is the youngest case reported in Japan. Additionally, we reviewed pediatric case reports of small intestinal cavernous hemangiomas. The use of wireless capsule endoscopy in children is effective and safe for preoperative detection of gastrointestinal bleeding caused by small intestinal lesions. • The intestinal hemangioma is rare disease. • There are only 10 cases reported solitary cavernous hemangiomas of the small intestine during childhood. • The use of the wireless capsule endoscopy in children is effective for preoperative detection of intestinal bleeding.

Machine learning for predicting hemorrhage in pediatric patients with brain arteriovenous malformation.

Ruptured brain arteriovenous malformations (bAVMs) in a child are associated with substantial morbidity and mortality. Prior studies investigating predictors of hemorrhagic presentation of a bAVM during childhood are limited. Machine learning (ML), which has high predictive accuracy when applied to large data sets, can be a useful adjunct for predicting hemorrhagic presentation. The goal of this study was to use ML in conjunction with a traditional regression approach to identify predictors of hemorrhagic presentation in pediatric patients based on a retrospective cohort study design. Using data obtained from 186 pediatric patients over a 19-year study period, the authors implemented three ML algorithms (random forest models, gradient boosted decision trees, and AdaBoost) to identify features that were most important for predicting hemorrhagic presentation. Additionally, logistic regression analysis was used to ascertain significant predictors of hemorrhagic presentation as a comparison. All three ML models were consistent in identifying bAVM size and patient age at presentation as the two most important factors for predicting hemorrhagic presentation. Age at presentation was not identified as a significant predictor of hemorrhagic presentation in multivariable logistic regression. Gradient boosted decision trees/AdaBoost and random forest models identified bAVM location and a concurrent arterial aneurysm as the third most important factors, respectively. Finally, logistic regression identified a left-sided bAVM, small bAVM size, and the presence of a concurrent arterial aneurysm as significant risk factors for hemorrhagic presentation. By using an ML approach, the authors found predictors of hemorrhagic presentation that were not identified using a conventional regression approach.

Comparison of Thromboelastography Devices TEG®6S Point of Care Device vs. TEG®5000 in Pediatric Patients Undergoing Cardiac Surgery.

Thromboelastography (TEG) can predict bleeding in pediatric patients undergoing cardiac surgery. We hypothesized that results obtained from TEG®5000 correlate with the new point-of-care TEG®6S system and that TEG®6S rewarming maximum amplitude (MA) is associated with surrogate endpoints for perioperative bleeding in pediatric patients who underwent complex cardiac surgery. We describe a retrospective study of pediatric (≤18 years) patients who underwent complex cardiac surgery on cardiopulmonary bypass. Citrate whole-blood samples were used to compared TEG®5000 vs.TEG®6S and TEG®6S-FLEV (with fibrinogen measurement) vs. Clauss-fibrinogen methods. TEG®6S parameters obtained during rewarming were compared to the surrogate endpoints for perioperative bleeding using linear regression analysis. Among 100 patients, 225 TEG®5000 vs.TEG®6S comparisons and 54 TEG®6S-FLEV were analyzed. Good correlation was observed for all parameters comparing TEG®5000 to TEG®6S and TEG®6S-FLEV to the Clauss-fibrinogen method (Pearson r ≥ .7). Similar to rewarming TEG®5000 MA, rewarming TEG®6S MA was the only parameter independently associated with risk for perioperative bleeding (median [interquartile range {IQR}] in bleeding vs. nonbleeding patients: 35 [29, 48] vs. 37 [32, 55]; p = .02). A platelet transfusion calculator was developed based on TEG®6S results by determining the relationship between platelet transfusion volume (mL/kg) and percent change in MA using linear regression analysis. TEG®6S is a good alternative point-of-care method to analyze a patient's coagulation profile and it is comparable to TEG®5000 in pediatric patients undergoing cardiac surgery on cardiopulmonary bypass. Lower TEG®6S MA during rewarming is associated with increased risk for perioperative bleeding. TEG analysis during rewarming may be useful in customizing platelet transfusion therapy by reducing the risk of bleeding while minimizing excessive blood product transfusions.

Comparison of Thromboelastography Devices TEG®6S Point of Care Device vs. TEG®5000 in Pediatric Patients Undergoing Cardiac Surgery

Thromboelastography (TEG) can predict bleeding in pediatric patients undergoing cardiac surgery. We hypothesized that results obtained from TEG®5000 correlate with the new point-of-care TEG®6S system and that TEG®6S rewarming maximum amplitude (MA) is associated with surrogate endpoints for perioperative bleeding in pediatric patients who underwent complex cardiac surgery. We describe a retrospective study of pediatric (≤18 years) patients who underwent complex cardiac surgery on cardiopulmonary bypass. Citrate whole-blood samples were used to compared TEG®5000 vs.TEG®6S and TEG®6S-FLEV (with fibrinogen measurement) vs. Clauss-fibrinogen methods. TEG®6S parameters obtained during rewarming were compared to the surrogate endpoints for perioperative bleeding using linear regression analysis. Among 100 patients, 225 TEG®5000 vs.TEG®6S comparisons and 54 TEG®6S-FLEV were analyzed. Good correlation was observed for all parameters comparing TEG®5000 to TEG®6S and TEG®6S-FLEV to the Clauss-fibrinogen method (Pearson r ≥ .7). Similar to rewarming TEG®5000 MA, rewarming TEG®6S MA was the only parameter independently associated with risk for perioperative bleeding (median [interquartile range {IQR}] in bleeding vs. nonbleeding patients: 35 [29, 48] vs. 37 [32, 55]; p = .02). A platelet transfusion calculator was developed based on TEG®6S results by determining the relationship between platelet transfusion volume (mL/kg) and percent change in MA using linear regression analysis. TEG®6S is a good alternative point-of-care method to analyze a patient’s coagulation profile and it is comparable to TEG®5000 in pediatric patients undergoing cardiac surgery on cardiopulmonary bypass. Lower TEG®6S MA during rewarming is associated with increased risk for perioperative bleeding. TEG analysis during rewarming may be useful in customizing platelet transfusion therapy by reducing the risk of bleeding while minimizing excessive blood product transfusions.

Spontaneous Intracerebral Hemorrhage in Pediatric Patients with Hemophilia A: Case Report and Review of Perioperative Management of Clotting Factor Concentrates

Intracerebral hemorrhage (ICH) is the leading cause of death in patients with hemophilia. The incidence of ICH is up to 50 times greater than that of the general population, and most frequently occurs in children less than two years of age and among those with the severe forms of the disease. The ideal perioperative management of this patient population, however, remains unclear.

Preoperative cephalhematoma size measured with computed tomography predicts intraoperative bleeding in pediatric patients undergoing cranioplasty.

BackgroundCranioplasty for the treatment of cephalhematomas in small infants with limited blood volume is challenging because of massive bleeding. This study aimed to elucidate the correlation between cephalhematoma size and intraoperative blood loss and identify criteria that can predict large intraoperative blood loss.MethodsWe reviewed the medical records of 120 pediatric patients aged less than 24 months who underwent cranioplasty for treatment of a cephalhematoma. The cephalhematoma sizes in preoperative brain computed tomography (CT) were measured using ImageJ.ResultsPearson correlation showed that the cephalhematoma size in the pre-operative brain CT was weakly correlated with intraoperative blood loss (Pearson coefficient = 0.192, P = 0.037). In a multivariable logistic regression analysis, a cephalhematoma size greater than 113.5 cm3 was found to be a risk factor for large blood loss. The area under the curve in the receiver operating characteristic plot of the multivariable model was 0.714 (0.619–0.809).ConclusionsA cephalhematoma size cutoff value of 113.5 cm3, as measured in the preoperative CT imaging, can predict intraoperative blood loss exceeding 30% of the total body blood volume. The establishment of a transfusion strategy prior to surgery based on cephalhematoma size could be useful in pediatric cranioplasty.

Thromboelastography During Rewarming for Management of Pediatric Cardiac Surgery Patients

BackgroundThromboelastography (TEG) predicts bleeding in pediatric patients undergoing cardiac surgical procedure. We hypothesize that TEG indicators at rewarming correlate with postprotamine values and that rewarming TEG is associated with surrogate end points for postoperative bleeding in pediatric patients undergoing complex cardiac surgical procedure. MethodsIn a retrospective study of 703 pediatric (≤18 years) patients undergoing complex cardiac surgical procedures, TEG results obtained during rewarming and after protamine administration were compared using linear regression. A composite end point of extended blood product transfusion or surgical reexploration for bleeding was used as a surrogate for postoperative bleeding. ResultsBy multivariable analysis, longer cardiopulmonary bypass time and lower TEG maximal amplitude (MA) during rewarming were independently associated with the risk of the composite end point in the operating room or in the intensive care unit (P < .05). Among patients with an MA of less than 45 mm during rewarming, those who received a platelet transfusion in the operating room compared with those who did not were less likely to reach the composite end point within the subsequent 24 hours (8% vs 32%, respectively; P < .01). Good correlation was observed between TEG variables at rewarming vs after protamine administration (Pearson r ≥ 0.7). The relationship between platelet transfusion volume (mL/kg) and the percentage change in the MA was determined using linear regression, and a platelet transfusion calculator was generated. ConclusionsA lower MA during rewarming is associated with an increased risk of perioperative bleeding. In patients with a rewarming MA of less than 45 mm, an intraoperative platelet transfusion may reduce the risk of subsequent bleeding. Individualized platelet transfusion therapy based on rewarming TEG may reduce the risk of bleeding while minimizing unnecessary platelet transfusion.

The Glasgow Outcome Scale-Extended Pediatric Scores of Intracranial Bleeding Patients with Acquired Prothrombin Complex Deficiency Post Craniotomy and Duraplasty

Introduction: Surgical evacuation of intracranial bleeding in pediatric patients due to acquired prothrombin complex deficiency (APCD) is a life-saving surgery when conservative treatment insufficient and impending brain herniation. This study aimed to evaluate the Glasgow outcome scale-extended pediatric (GOS-ePed) score of the pediatric intracranial bleeding patients with APCD after craniotomy and duraplasty. Method: This was a retrospective study in the last 5 years of our experience. All of the pediatric patients with intracranial bleeding due to APCD who needed surgery were investigated. The data were collected from medical records after their parents have given their written informed concern and approved by the Ethics Review Committee, Faculty of Medicine, Universitas Kristen Indonesia. The inclusion criteria were patients who operated on by craniotomy and duraplasty. The patient with a second disease was excluded. Blood tests include hemoglobin, prothrombin time, activated prothrombin time, and platelets were investigated before and after intravenous vitamin K injection, transfusion packed red cells (PRCs), and fresh frozen plasma (FFP) administration. The Glasgow coma scale (GCS) pre- and postoperatively was evaluated using a modified GCS for infants and children. The outcome was evaluated by the GOS-ePed score. All data were analyzed with the normality test and paired t test. Results: There were 5 patients age between 37 and 60 days, and all patients did not get vitamin K prophylaxis after birth. The blood tests of all patients revealed anemia, prothrombin, and activated prothrombin time increased, but platelets were normal. All these values returned to normal after vitamin K injection, transfusion of PRCs, and FFP. The paired t tests were p < 0.05. The GCS of all patients before surgery was 8 or below. After surgery, the GCS of 4 patients was increased become 12 and 15. One patient did not change significantly. The GOS-ePed score showed 4 patients (80%) had upper or lower good recovery, and 1 patient (20%) was in a vegetative state. Conclusions: The GOS-ePed score of the pediatric intracranial bleeding with APCD after craniotomy and duraplasty was mostly in upper or lower good recovery.

Pharmacokinetics, Efficacy and Safety of a Plasma-Derived VWF/FVIII Concentrate (Formulation V) in Pediatric Patients with von Willebrand Disease (SWIFTLY-VWD Study).

PurposeFormulation V (VONCENTO®) is a plasma-derived high-concentration/low-volume, high-purity von Willebrand factor (VWF)/factor VIII (FVIII) concentrate, originally indicated for von Willebrand disease (VWD) in adults and adolescents. This multicenter, open-label study (SWIFTLY-VWD) evaluated the pharmacokinetics (PK), as well as hemostatic efficacy and safety, of Formulation V in pediatric patients (<12 years) with severe VWD requiring treatment or prophylaxis of bleedings.MethodsPK investigations were performed following one dose of Formulation V at Day 1 and 180. Nonsurgical bleeds were analyzed, while hemostatic efficacy was graded as excellent/good/moderate/none. Safety assessments included adverse events, and presence of VWF and/or FVIII inhibitors.ResultsFormulation V was administered as on-demand (N=13) or prophylaxis therapy (N=4) for 12 months (<6 years, N=9; 6 to <12 years, N=8). PK parameters for VWF markers were generally comparable to adults but showed lower VWF:ristocetin cofactor (RCo) exposure. Incidence of major bleeds was lower for prophylaxis (3.3%) than on-demand therapy (27.1%); joint bleeds were also lower (3.3% vs 11.5%, respectively). Investigator-reported excellent/good hemostatic efficacy against nonsurgical bleeds was 100%. No clinically relevant differences in PK, hemostatic efficacy, or safety were observed between age-groups (<6 years and 6 to <12 years). Formulation V was well tolerated. Adverse events were mild–moderate and consistent with the adult safety profile. No cases of anaphylactic reactions or angioedema, development of FVIII/VWF inhibitors, thromboembolic events, or viral infections were reported.ConclusionThis study provides evidence for use of Formulation V to treat and prevent bleeding in pediatric patients with severe VWD, and led to the European approval of Formulation V in children.

Association of Blood Type With Postsurgical Mucosal Bleeding in Pediatric Patients Undergoing Tonsillectomy With or Without Adenoidectomy

Blood type (BT) O has been identified as a risk factor for bleeding complications, while non-O BTs may increase risk for thromboembolic events. Limited data are available in children undergoing tonsillectomy with or without adenoidectomy. To determine whether BT O is associated with hemorrhage after tonsillectomy with or without adenoidectomy. Retrospective cohort study of patients younger than 22 years who underwent tonsillectomy with or without adenoidectomy at a single institution between January 1, 2008, and August 7, 2017. Statistical analysis was performed from November 2017 to January 2019. Prevalence of hemorrhage following surgery was defined as any bleeding requiring cauterization up to 1 month after the procedure. Data on sex, age, von Willebrand disease (VWD) status, BT, white blood cell counts, and platelet counts closest to date of surgery were collected from an electronic medical record system, and the association of these factors with hemorrhage following surgery was investigated. A total of 14 951 pediatric patients (median [range] age, 5.6 [0.8-21.9] years; 6956 [46.5%] female) underwent tonsillectomy with or without adenoidectomy. Prevalence of hemorrhage following the procedure was 3.9% (578 patients) for the full cohort and 2.8% (362 of 13 065) for patients with no BT identified or preprocedure VWD panel results at baseline. Children who had a BT identified and/or a VWD panel before surgery had higher bleeding rates (BT only, 14.9% [172 of 1156]; preprocedure VWD panel only, 4.6% [28 of 607]; and BT and preprocedure VWD panel, 13.0% [16 of 123]), all of which were significantly different from the baseline bleeding rate (P < .001). While the bleeding rates in children with BT O were not statistically different from those with non-O BT (14.8% and 14.6%, respectively; P > .99), mean von Willebrand factor values were statistically different (mean [SD] von Willebrand factor antigen level in O group, 86.9 [42.4] IU/dL in the O group vs 118.0 [53.8] IU/dL in the non-O group; P = .002; and mean [SD] von Willebrand factor ristocetin-cofactor in the O group, 72.2 [44.3] IU/dL vs 112.6 [68.0] IU/dL in the non-O group; P = .001). In addition, children older than 12 years had increased bleeding rates in the full cohort (8.3% vs 3.2%), in the testing-naive cohort (6.5% vs 2.3%), and in those with a preprocedure VWD panel only (13.5% vs 3.1%) compared with children aged 12 years or younger. Type O blood was not a risk factor associated with hemorrhage after tonsillectomy with or without adenoidectomy despite lower baseline von Willebrand factor antigen and von Willebrand factor ristocetin-cofactor values in children with BT O vs those with non-O BT in our study cohort. No association was found between VWD status and bleeding, and there was no difference in VWD panel values in those who experienced hemorrhage vs those who did not within BT groups. Further studies elucidating the utility of von Willebrand factor values for children undergoing tonsillectomy with or without adenoidectomy are needed.

Endoscopic variceal ligation as primary prophylaxis for upper GI bleeding in children

Variceal hemorrhage can be a life-threatening adverse event of chronic liver disease. In contrast to the well-described guidelines for the management of portal hypertension (PH) in adults, there is limited evidence about the optimal prophylactic management of variceal bleeding in children. This study was carried out to assess the efficacy of endoscopic variceal ligation (EVL) as primary prophylaxis to prevent upper GI bleeding in children with PH. From January 2014 to April 2018, all pediatric patients with PH disease and medium to large esophageal varices or reddish spots, regardless of the grade of the varix, were prospectively included in the protocol of primary prophylaxis with EVL. A second retrospective group of patients was made after reviewing medical records of 32 pediatric patients with PH that presented esophageal varices in the upper endoscopy and had received propranolol as primary prophylaxis. Twenty-four patients (75%) reached varices eradication in the EVL group, with a median of 2 procedures (range, 1-4) before eradication and a median time to eradication of 3.40 months (range, 1.10-13.33). No EVL-related adverse events were observed. Statistically significant differences were observed in the bleeding rate at 3 years between propranolol and EVL groups (6/32 [21.9%] vs 1/32 [3.2%], P< .02). The hazard ratio for bleeding for patients treated with propranolol compared with those treated with EVL was 2.6 (95% confidence interval, 1.53-3.67). EVL is a safe and effective treatment to prevent upper GI bleeding in pediatric patients with PH. (Clinical trial registration number: NCT03943784.).