Hemostatic Powder Research Articles

GI Bleeding.

Introduction: Standard of care (SOC) in managing malignant gastrointestinal bleeding (GIB), including traditional endoscopic, radiological, surgical and radiotherapeutic approaches, is limited in hemostatic effectiveness. TC-325 is a novel endoscopic hemostatic powder that has shown promise in managing such patients. Methods: Adult patients were randomized at urgent endoscopy to TC-325 or SOC if they presented with upper or lower GIB and a known luminal GI malignancy confirmed to be the source of bleeding. The primary outcome was immediate hemostasis (absence of bleeding for at least 3 minutes after endoscopic therapy). Secondary outcomes included clinical rebleeding, transfusion use, ICU, LOS, additional treatment and mortality. Results: A pre-planned 20 patients were randomized to TC-325 or SOC (25% female, age 67.2±15.9 years, 2.9±1.7 comorbidities). Adopted research methods performed well in securing informed consent and measuring pertinent clinical outcomes. An initial source of bleeding was found in 85% of patients, with oozing noted in 95.0%. Immediate hemostasis was achieved in 90% (95%CI: 59.6;98.2) of patients treated initially with TC-325 versus 40% (16.8;68.7) in the SOC group. After failed immediate hemostasis with SOC, 83.3% (43.7; 97.0) of patients crossed over to TC-325, with hemostasis then being achieved at the index endoscopy in 80% (37.6;96.4) of these cross-overs. None of the TC-325 patients crossed over to SOC (the sole patient having failed TC-325 died of exsanguination at index gastroscopy from rupture of a malignant inferior mesenteric artery aneurysm before other endoscopic modalities could be attempted). Overall, hemostasis at index endoscopy was achieved in 87.7% (62.1;96.3) whether initial treatment with TC-325 or following SOC failure. Rebleeding was lower in the TC-325 group (22.2% (0;56.1)) compared to patients treated with SOC (60% (23.1;96.9)). Other outcomes are shown in table 1. Conclusion: This pilot trial is the first to assess TC-325 in malignant bleeding and demonstrates the feasibility of a larger randomized trial with regards to recruitment and adequate powering for hemostatic outcomes. Although this trial was not designed to seek statistically significant differences, the results suggest that TC-325 may indeed be a promising hemostatic modality in managing patients with malignant bleeding both in achieving immediate hemostasis and decreased subsequent rebleeding compared to existing standard of care.Table: Table. Primary and secondary outcomes

Recent advances in the management of peptic ulcer bleeding.

Acute upper gastrointestinal haemorrhage due to peptic ulcer bleeding remains an important cause of emergency presentation and hospital admission. Despite advances in many aspects of management, peptic ulcer bleeding is still associated with significant morbidity, mortality, and healthcare costs. Comprehensive international guidelines have been published, but advances as well as controversies continue to evolve. Important recent advances include the evidence supporting a more restrictive transfusion strategy aiming for a target haemoglobin of 70–90 g/l. Comparative studies have confirmed that the Glasgow–Blatchford score remains the most useful score for predicting the need for intervention as well as for identifying the lowest-risk patients suitable for outpatient management. New scores, including the AIMS65 and Progetto Nazionale Emorragia Digestiva score, may be more accurate in predicting mortality. Pre-endoscopy erythromycin appears to improve outcomes and is probably underused. High-dose oral proton pump inhibition (PPI) for 11 days after PPI infusion is advantageous in those with a Rockall score of 6 or more. Oral is as effective as parenteral iron at restoring haemoglobin levels after a peptic ulcer bleed and both are superior to placebo in this respect. Within endoscopic techniques, haemostatic powders and over-the-scope clips can be used when other methods have failed. A disposable Doppler probe appears to provide more accurate determination of both rebleeding risk and the success of endoscopic therapy than purely visual guidance. Non- Helicobacter pylori, non-aspirin/non-steroidal anti-inflammatory drug ulcers contribute an increasing percentage of bleeding peptic ulcers and are associated with a poor prognosis and high rebleeding rate. The optimal management of these ulcers remains to be determined.

Self-Made, Cost-Reducing Hemostatic Agent for Use in Spine Surgery.

Operative bleeding complications can lead to patient morbidity and mortality as well as longer and increased hospitalization costs. Matrix hemostatic sealants are used commonly to shorten the time to hemostasis, operative times, and the need for blood transfusion. Commercially available hemostatic powders are used in spine surgery because of their ability to conform to wounds and decrease bleeding in difficult-to-access surgical sites. Hospital costs for these agents are variable and are dependent on negotiated institutional contracted prices. We present our technique for mixing and use of our own hemostatic agent that has been used by our senior spine surgeons for more than a decade. It uses supplies that are commonly found in the hospital for a fraction of the cost and at different concentrations of thrombin. We hope that this report serves to assist surgeons working in hospitals with limited resources and enriches their armamentarium of hemostatic agents.

Use of hemostatic powder in bleeding portal hypertensive gastropathy.

Use of hemostatic powder in bleeding portal hypertensive gastropathy.

Hemostatic powder: a new ally in the management of postsphincterotomy bleeding.

Hemostatic powder: a new ally in the management of postsphincterotomy bleeding.

Experimental Evaluation of Tranexamic Acid–Loaded Porous Starch as a Hemostatic Powder

We evaluated the effectiveness of a novel hemostatic powder called Tranexamic Acid-loaded Porous Starch (TAPS) developed recently on blood clotting activity and hemostasis. The effectiveness of TAPS was evaluated by comparing hemostatic properties with those of Quick-acting Styptic Powder (QSP) and Compound Microporous Polysaccharide Haemostatic powder (CMPHP). The blood clotting activities of human blood were analyzed by thromboela-stogram (TEG) assays in vitro. The hemostatic effectiveness in vivo was evaluated using a rat model with hepatic traumatic hemorrhage. The blood loss and standardized bleeding score, which reflects the degree of bleeding after treatment with styptic powder, were used to evaluate hemostatic efficacy. In vitro, the values of TEG parameters in TAPS group were significantly different, compared with untreated controls or CMPHP group (p < 0.05). In vivo, the application of QSP, CMPHP and TAPS led to significantly decreased post-treatment blood loss than in the control group (p < 0.01). The scores of the groups treated with QSP, CMPHP and TAPS (0, 0.2±0.422, 0.3±0.483, respectively) were significant lower than with gauze control (1.6±0.516) which success hemostatic was achieved at 5 minutes (p < 0.01). Hemostasis was achieved successfully within approximately 4 minutes after the application of TAPS. TAPS could help blood to form an artificial scab on a wound and to seal injuries for hemostasis to reduce blood loss in rats with hepatic trauma and hemorrhage. It was safe to use with no impact on blood clotting function or other apparent side effects.

Massive small-bowel bleeding treated with hemostatic powder.

Massive small-bowel bleeding treated with hemostatic powder.

Mo2030 Hemostatic Spray Powder, in Critical Gastrointestinal Bleeding. A Highly Effective Treatment Alternative

Mo2030 Hemostatic Spray Powder, in Critical Gastrointestinal Bleeding. A Highly Effective Treatment Alternative

Mo1973 Efficacy of Hemostatic Powder (Endo-Clottm) in Preventing Bleeding After Gastric Endoscopic Submucosal Dissection in High-Risk Bleeding Patients

Mo1973 Efficacy of Hemostatic Powder (Endo-Clottm) in Preventing Bleeding After Gastric Endoscopic Submucosal Dissection in High-Risk Bleeding Patients

627 Multicentre Randomised Controlled Trial Comparing the Efficacy and Safety of Adding Early Hemostatic Powder Application to Endoscopic and Medical Treatment in the Management of Acute Variceal Bleeding in Cirrhotic Patients

627 Multicentre Randomised Controlled Trial Comparing the Efficacy and Safety of Adding Early Hemostatic Powder Application to Endoscopic and Medical Treatment in the Management of Acute Variceal Bleeding in Cirrhotic Patients

The Application of Hemospray in Gastrointestinal Bleeding during Emergency Endoscopy.

Introduction. Gastrointestinal bleeding represents the main indication for emergency endoscopy (EE). Lately, several hemostatic powders have been released to facilitate EE. Methods. We evaluated all EE in which Hemospray was used as primary or salvage therapy, with regard to short- and long-term hemostasis and complications. Results. We conducted 677 EE in 474 patients (488 examinations in 344 patients were upper GI endoscopies). Hemospray was applied during 35 examinations in 27 patients (19 males), 33 during upper and 2 during lower endoscopy. It was used after previous treatment in 21 examinations (60%) and in 14 (40%) as salvage therapy. Short-term success was reached in 34 of 35 applications (97.1%), while long-term success occurred in 23 applications (65.7%). Similar long-term results were found after primary application (64,3%) or salvage therapy (66,7%). Rebleeding was found in malignant and extended ulcers. One major adverse event (2.8%) occurred with gastric perforation after Hemospray application. Discussion. Hemospray achieved short-term hemostasis in virtually all cases. The long-term effect is mainly determined by the type of bleeding source, but not whether it was applied as first line or salvage therapy. But, even in the failures, patients had benefit from hemodynamic stabilization and consecutive interventions in optimized conditions.

Structural Alteration in Dermal Vessels and Collagen Bundles following Exposure of Skin Wound to Zeolite-Bentonite Compound.

Background. This study examines the impact of one-time direct application of haemostatic agent zeolite–bentonite powder to wounded skin on the healing process in rats. Materials and Methods. 24 male Sprague-Dawley rats were randomly allocated into two groups (n = 12): (1) the rats whose wounds were washed only with sterile normal saline (NS-treated) and (2) those treated with zeolite–bentonite compound (ZEO-treated). The wound was circular, full-thickness, and 2 cm in diameter. At the end of the 12th day, six animals from each group were randomly selected and terminated. The remaining rats were terminated after 21 days. Just after scarification, skin samples were excised and sent for stereological evaluation. Results. The results showed a significant difference between the two groups regarding the length density of the blood vessels and diameter of the large and small vessels on the 12th day after the wound was inflicted. Besides, volume density of both the dermis and collagen bundles was reduced by 25% in the ZEO-treated rats in comparison to the NS-treated animals after 21 days. Conclusions. One-time topical usage of zeolite–bentonite haemostatic powder on an animal skin wound might negatively affect the healing process through vasoconstriction and inhibition of neoangiogenesis.

Hemospray for treatment of acute bleeding due to upper gastrointestinal tumours

BackgroundHemospray is a new endoscopic haemostatic powder that can be used in the management of upper gastrointestinal bleedings. AimsTo assess the efficacy and safety of Hemospray as monotherapy for the treatment of acute upper gastrointestinal bleeding due to cancer. MethodsThe endoscopy databases of 3 Italian Endoscopic Units were reviewed retrospectively and 15 patients (8 males; mean age 74 years) were included in this study. ResultsImmediate haemostasis was achieved in 93% of cases. Among the successful cases, 3 re-bled, one case treated with Hemospray and injection had a good outcome, while 2 cases died both re-treated with Hemospray, injection and thermal therapy. No complications related to Hemospray occurred. Finally, 80% of patients had a good clinical outcome at 30days and 50% at six months. ConclusionHemospray may be considered an effective and safe method for the endoscopic management of acute neoplastic upper gastrointestinal bleedings.

Endoscopic treatment of upper-GI ulcer bleeding with hemostaticpowder spray.

Endoscopic treatment of upper-GI ulcer bleeding with hemostaticpowder spray.

Severe acute diverticular bleeding: successful treatment with hemostatic powder

A 50-year-old man was admitted to the intensive coronary care unit for acute myocardial infarction and was treated by coronary artery stenting and dual antiplatelet therapy. On postprocedure day 5, the patient presented with massive hematochezia, anemia (hemoglobin 10.4 g/dL), and hypovolemic shock. After hemodynamic stabilization, a mesenteric angiogram revealed a left-sided colonic hemorrhage highly suggestive of diverticular bleeding (A, white arrow). Selective embolization was ruled out because of the risk of bowel infarction. An urgent colonoscopy showed bright red blood and multiple diverticula in the left side of the colon. After profuse water irrigation, active arterial bleeding from a diverticulum was identified 35 cm from the anal verge (B). After the bleeding site was marked with an endoclip, hemostasis was attempted, but without success, by a combination of adrenaline injection followed by endoclip positioning. The bleeding vessel was within the dome of a deep diverticulum with a small orifice. Because of the massive bleeding, an endocap to evert the diverticulum and performance of clip deployment or band ligation was difficult. Therefore, a spray catheter application of 2 g topical hemostatic powder (EndoClot polysaccharide hemostatic system [PHS], EndoClot Plus, Inc., Santa Clara, Calif) inside the lumen of diverticulum was carried out (C). Hemostasis was rapidly achieved (D), and no rebleeding had occurred by a 30-day follow-up visit, even after the readministration of dual antiplatelet therapy.

Hemostatic Powder to Staunch Upper Gastrointestinal Bleeding

Pilot studies of a mineral-based hemostatic powder (TC-325) have shown some success for upper gastrointestinal bleeding (UGIB). In a study of TC-325

Editorial Comment

The authors are to be congratulated for performing a prospective randomized trial pertaining to the incidence and possible prevention of pelvic lymphoceles following pelvic lymph node dissection (PLND) during robotic-assisted radical prostatectomy (RARP) with an absorbable hemostatic agent (Arista AH). 1 Gilbert D.R. Angell J. Seager C. Abaza R. Evaluation of absorbable hemostatic powder for prevention of lymphoceles following robotic prostatectomy with lymphadenectomy. Urology. 2016; https://doi.org/10.1016/j.urology.2016.06.071 Abstract Full Text Full Text PDF Scopus (15) Google Scholar The authors provide a nice discussion regarding the incidence of pelvic lymphoceles following RARP and PLND. Although symptomatic lymphoceles may be very costly and difficult to deal with, they are not common. In fact, the authors note the absence of symptomatic lymphoceles in this study. We may be chasing a problem that does not need to be addressed. For that reason, I loathe cross-sectional imaging following RARP and PLND. The finding of asymptomatic lymphoceles on imaging provides patients, families, and treating physician's unnecessary anxiety. One conclusion I reach from this study is that we probably should not be looking for trouble with the use of postoperative imaging.

EndoClot Polysaccharide Hemostatic System in Nonvariceal Gastrointestinal Bleeding

Hemostatic powders have been introduced to improve the management of gastrointestinal (GI) bleeding and to extend the variety of tools available for emergency endoscopy. The aim of the present pilot study was to evaluate the indication profiles and the short-term outcome of EndoClot. In a prospective observational pilot study patients with acute nonvariceal GI bleeding were included. Primary or secondary application of EndoClot was assessed. Hemoglobin, prothrombine time and platelets were documented before and after hemostasis. The efficacy of EndoClot was assessed 72 hours and 1 week after application. Seventy patients with acute GI bleeding were recruited into the study. Eighty-three percent (58/70) of the patients had upper and 17% (12/70) had lower GI bleeding. In the upper GI tract treatment success was achieved in 64% (30/47, 95% confidence interval, 50%-76%) after primary use and in all patients, when used after established techniques had failed (95% confidence interval, 70%-100%). In lower GI bleeding hemostasis was achieved in 83% of cases (10/12, 95% confidence interval 54%-97%). Rebleeding occurred in 11% (8/70), in 10% EndoClot served as a bridge to surgery (7/70). EndoClot expanded the therapeutic options in the management of GI bleeding. It was applicable as a monotherapy or in combination with other techniques from oozing bleeding type or lower. It was most effective in diffuse or extensive bleeding activity or when access to the bleeding vessel was difficult. EndoClot can be applied as a bridge to surgery when classical methods of hemostasis have failed.

Evaluation of Absorbable Hemostatic Powder for Prevention of Lymphoceles Following Robotic Prostatectomy With Lymphadenectomy

To determine whether lymphoceles can be prevented after robotic prostatectomy with pelvic lymph node dissection (PLND), we performed a prospective randomized study using an absorbable hemostatic agent (Arista AH). The most common complications of PLND for prostate cancer are related to lymphocele formation, which occur in 30%-50% of patients according to studies that performed screening imaging. Although most are asymptomatic, when intervention is required the cost and morbidity are high. Of 100 patients enrolled, 88 completed the study. Each patient served as his or her own control, with Arista AH placed over the field of PLND on only one side in a randomized fashion as revealed only after bilateral PLND was completed. All patients underwent screening pelvic computed tomography scan 3 months later, with radiologists blinded to the Arista AH treated side. A significant lymphocele was defined as a fluid collection 3 cm or greater in any plane. The mean lymph node yield was 8.1 nodes. Fourteen lymphoceles were identified. Five occurred on the side where Arista AH was used vs 9 on untreated sides (5.7% vs 10.2%, P = .248). When they occurred, there was no statistically significant difference in lymphocele size between treated and untreated sides (P = .441). No lymphoceles were symptomatic. Although the lymphocele rate with Arista AH was 5.7% compared with 10.2% without it, this was not a statistically significant difference potentially because the study was underpowered due to an unusually low baseline rate of lymphoceles. A larger study is warranted to determine whether using a hemostatic agent like Arista AH can prevent lymphoceles.

Improvement of the treatment of gastrointestinal bleeding (GIB) by the use of EndoClot hemostatic powder

Gastrointestinal bleeding (GIB) can be due to a plethora of disease, such as ulcers and liver cirrhosis or can occur as result of iatrogenic interventions such as polypectomy. GIB is still a demanding indication for GI endoscopy with high morbidity and mortality rates. To further increase the endoscopist's armament, hemostatic powders such as EndoClot have been developed. In this study, we evaluated the application of EndoClot during routine and emergency endoscopy during a one year period.