Hemostatic Powder Research Articles

1998 Hemostatic Spray for Secondary Hemostasis Following Endoscopic Variceal Band Ligation

INTRODUCTION: Endoscopic application of hemostatic powder for the treatment of GI bleeding has now been well-described in the literature and utilized for multiple years in clinical practice. Its use as primary and salvage therapy in upper GI bleeding has been established following its approval for non-variceal GI bleeding. Successful use has even been reported in post-variceal banding ulcers, however in very small patient numbers with comparatively less data in acute, ulcerated, post- banding bleeding occurring with simultaneous gastric and esophageal varices. CASE DESCRIPTION/METHODS: We present a case of a 57-year-old male with medical history including hepatitis C, cirrhosis, tobacco use, chronic kidney disease, duodenal ulcer, gastritis, ascites, esophageal varices, and diffuse/infiltrative hepatocellular carcinoma associated with tumor thrombus of the portal and hepatic veins who presented to the emergency department for new melenic stools. Hemoglobin was 12.4 g/dL on presentation, decreased to 10.2 g/dL by consultation at which time the melena progressed to hematochezia with an episode of hematemesis. The calculated MELD-sodium score was 19. Physical examination was pertinent for soft, distended abdomen without tenderness and no asterixis. IV ceftriaxone, pantoprazole, and octreotide were initiated. The patient received a single unit of packed red blood cells during hospitalization. EGD demonstrated large distal esophageal varices and an actively-spurting Type 1 (GOV1) gastroesophageal varix. Two bands were placed on esophageal varices and the gastric varix was banded to eradication with cessation of bleeding. Hematemesis recurred the following day and repeat EGD was performed for salvage therapy noting that prior evaluation deemed the patient non-candidate for liver transplant or TIPS procedure. Ulcerated varices were encountered at the prior banding sites with a large pool of coagulated blood in the stomach and hemostatic spray was successfully applied to each site. Hemoglobin remained stable after repeat hemostatic therapy without subsequent need for transfusion. DISCUSSION: Ordinarily, persistent bleeding following variceal banding in decompensated cirrhosis warrants TIPS consideration if a candidate and needed for rescue therapy. However, this case lends credence to the use of hemostatic spray in non-TIPS candidates for treatment of post-banding ulcerated variceal bleeding in both esophageal and gastric etiologies.

2753 Got the GIST: Multidisciplinary Management of an Acute Bleeding Gastrointestinal Stromal Tumor

INTRODUCTION: Gastrointestinal stromal tumors (GISTs) account for 1%-3% of all gastrointestinal tumors. They most commonly arise in the stomach followed by the jejunum/ileum. Presentation varies from incidental discovery during autopsy or endoscopy to acute gastrointestinal (GI) bleeding or bowel obstruction. We report a case of this rare neoplasm in a patient with an acute GI bleed, treated endoscopically with hemostatic spray and ultimately with arterial embolization and surgical resection. CASE DESCRIPTION/METHODS: A 67-year-old female with a family history of colorectal cancer presented to the emergency department for hematemesis and left lower quadrant abdominal pain for 1 day. Physical examination was notable for left lower quadrant tenderness to palpation. Initial laboratory data showed a hemoglobin of 12.8 g/dL from 14.4 g/dL 8 months prior. A CT scan of the abdomen demonstrated a 3.2 × 4.1 cm well-circumscribed mass along the lesser curvature of the stomach arising from the gastric wall. Overnight, she had an episode of large volume hematemesis and became tachycardic and hypotensive. Her hemoglobin dropped to 7 g/dL. An esophagogastroduodenoscopy (EGD) showed LA Grade D esophagitis and a submucosal ulcerated gastric tumor on the lesser curvature of the stomach to which Hemostatic powder spray was applied. She initially refused surgical intervention and remained hemodynamically stable for ∼12 hours after EGD. She then had multiple episodes of hematemesis with hypotension despite blood transfusions. She underwent embolization to the left gastric artery after which hemostasis was achieved. She then decided to proceed with surgical resection of the gastric mass. Pathology confirmed the diagnosis of GIST, spindle-cell type with strongly positive stains for DOG-1 and CD117. DISCUSSION: GISTs are rare tumors that originate from mesenchymal stem cells. Although 40% of gastric GISTs present with GI bleeding, there are no clear guidelines on the management of these lesions. Therapeutic endoscopy and arterial embolization are effective methods used in the management of GISTs with acute bleeding. Hemostatic spray, an inorganic powder that concentrates clotting factors on bleeding surfaces, can be used adjunctively to other methods for the management of bleeding GISTs especially when traditional endoscopic techniques are challenging or when surgery is not an option. This case highlights the importance of a multidisciplinary approach in the management of these rare tumors.

Endoscopic Management of Post-Polypectomy Bleeding.

Post-polypectomy bleeding (PPB) is one of the most common complications of endoscopic polypectomy. There are multiple risk factors related to patient and polyp characteristics that should be considered. In most cases, immediate PPB can be effectively managed endoscopically when recognized and managed promptly. Delayed PPB can manifest in a myriad of ways. In severe delayed PPB, resuscitation for hemodynamic stabilization should be prioritized, followed by endoscopic evaluation and therapy once the patient is stabilized. Future areas of research in PPB include the risks of direct oral anticoagulants and of specific electrosurgical settings for hot-snare polypectomy vs. cold-snare polypectomy, benefits of closure of post-polypectomy mucosal defects using through-the-scope clips, and prospective comparative evaluation of newer hemostasis agents such as hemostatic spray powder and over-the-scope clips.

Use of hemostatic drug Spongostan as a carrier of mesenchymal stem cells in the treatment of experimental urinary incontinence in rats

The adhesion and proliferation of rat adipose-derived mesenchymal stem cells (MSCs) as part of biocomposite with haemostatic drug Spongostan Absorbable Haemostatic Gelatin Powder as well as its regenerative efficiency after its introduction into the periurethral region in rats with experimental urinary incontinence were studied. It was found that MSCs rapidly adhere to the surface of the carrier and actively proliferate. The periurethral injection of biocomposite (Spongostan + MSCs) quickly and effectively recovers the urine continence function in animals that have undergone modeling of incontinence by urethrolysis. Spongostan hydrated in the ratio of 1 :24 inphosphate-saline buffer has a volume-forming effect in the urethra of experimental animals.

Endoscopic Therapy for Acute Diverticular Bleeding.

Diverticular bleeding accounts for approximately 26%–40% of the cases of lower gastrointestinal bleeding. Rupture of the vasa recta at the neck or dome of the diverticula can be the cause of this bleeding. Colonoscopy aids in not only the diagnosis but also the treatment of diverticular bleeding after a steady bowel preparation. Endoscopic hemostasis involves several methods, such as injection/thermal contact therapy, clipping, endoscopic band ligation (EBL), hemostatic powder, and over-the-scope clips. Each endoscopic method can provide a secure initial hemostasis. With regard to the clinical outcomes after an endoscopic treatment, the methods reportedly have no significant differences in the initial hemostasis and early recurring bleeding; however, EBL might prevent the need for transcatheter arterial embolization or surgery. In contrast, the long-term outcomes of the endoscopic treatments, such as a late bleeding and recurrent bleeding at 1 and 2 years, are not well known for diverticular bleeding. With regard to a cure for diverticular bleeding, there should be an improvement in both the endoscopic methods and the multilateral perspectives, such as diet, medicines, interventional approaches, and surgery.

TC-325 hemostatic powder versus current standard of care in managing malignant GI bleeding: a pilot randomized clinical trial

TC-325 (Hemospray; Cook Medical, Winston-Salem, NC, USA), an endoscopic hemostatic powder, exhibits possible benefits in patients with malignant GI bleeding. Our aim is to assess feasibility and determine estimates of efficacy of TC-325 compared with standard of care (SOC) in terms of initial hemostasis and recurrent bleeding rates in comparable groups of patients with malignant GI bleeding. Adult patients presenting with acute malignant upper or lower GI bleeding were randomized to TC-325 or SOC. Measured outcomes included feasibility of recruitment and randomization in the urgent care setting, immediate hemostasis, recurrent bleeding, need for additional treatment modalities, and mortality. A preplanned 20 patients (upper GI source in 85%) were randomized 1:1 to TC-325 or SOC (25% women, age 67.2 ± 15.9 years, oozing in 95%) over 20 months. Immediate hemostasis was achieved in 90% of patients treated initially with TC-325 versus 40% in the SOC group (P= .057). Overall, 83.3% crossed over to TC-325, with hemostasis then achieved at index endoscopy in 80%. Overall, hemostasis at index endoscopy (before or after crossover) was obtained in 87.7% of patients treated with TC-325. Recurrent bleeding over the next 180 days was 20% in the TC-325 group compared with 60% in the SOC group (P= .170). This pilot trial demonstrates the feasibility of TC-325 in malignant GI bleeding and provides results to help inform a larger randomized trial. Although not powered for such, results suggest that use of TC-325 is a very promising modality in malignant GI bleeding in achieving immediate hemostasis and may even result in decreased subsequent recurrent bleeding. (Clinical trial registration number: NCT02135627.).

Treatment of nonvariceal upper gastrointestinal bleeding: endoluminal-endovascular-surgical

Nonvariceal upper gastrointestinal bleeding (UGIB) has a high mortality. Hematemesis sometimes with melena are the leading clinical symptoms. Peptic ulcers and (erosive) inflammation are common, whereas Mallory-Weiss syndrome, neoplasms, angiodysplasia and diffuse UGIB are less common. A risk stratification is based on the medical history, clinical presentation and laboratory tests, which are considered in the Glasgow-Blatchford score; however, which treatment approach is optimal? After stabilisation under restricted transfusion indications, temporary stoppage of anticoagulants and optimized coagulation is beneficial and proton pump inhibitors (PPI) should be started. Prokinetics improve the endoscopic conditions in UGIB. The use of an endoscopic Doppler probe optimizes localization of the bleeding site. The use of the Forrest classification and Helicobacter pylori diagnostics are recommended. Mechanical (clips, injection), thermal (argon plasma coagulation, APC) and topical (hemostatic powder) endoscopic treatment procedures are available. Endoluminal hemostasis is very effective. Only clip application is suitable as monotherapy whereas all other endoscopic options should be combined. Angiography followed by transarterial embolization (TAE) can be used for therapy. Despite the high primary success rate, the risk of rebleeding is high. Surgery as the primary treatment is rarely necessary, although effective. Compared to TAE complications are higher, but there is no difference regarding mortality. Endoscopy remains the gold standard for the initial diagnostics and treatment of UGIB. In cases of rebleeding repeated endoscopy is recommended. With persistent UGIB an endovascular procedure should be evaluated. Surgery remains an important salvage option.

Hemostatic spray powder TC-325 for GI bleeding in a nationwide study: survival and predictors of failure via competing risks analysis

TC-325 (Hemospray, Cook Medical, Winston-Salem, NC) is an inorganic hemostatic powder recently approved by the U.S. Food and Drug Administration. This study aimed to examine the effectiveness, safety, and predictors of TC-325 failure in a large real-life cohort. This was a retrospective study conducted at 21 Spanish centers. All patients treated with TC-325 until September 2018 were included. The primary outcome was treatment failure, defined as failed intraprocedural hemostasis or recurrent bleeding within the first 30 postprocedural days. Secondary outcomes included safety and survival. Risk and predictors of failure were assessed via competing-risk models. The cohort comprised 261 patients, of whom 219 (83.9%) presented with upper gastrointestinal bleeding (GIB). The most common causes were peptic ulcer (28%), malignancy (18.4%), and therapeutic endoscopy-related GIB (17.6%). TC-325 was used as rescue therapy in 191 (73.2%) patients. The rate of intraprocedural hemostasis was 93.5% (95% confidence interval [CI], 90%-96%). Risks of TC-325 failure at postprocedural days 3, 7, and 30 were 21.1%, 24.6%, and 27.4%, respectively. On multivariate analysis, spurting bleeding (P= .004), use of vasoactive drugs (P= .02), and hypotension (P= .008) were independent predictors of failure. Overall 30-day survival was 81.9% (95% CI, 76%-86%) and intraprocedural hemostasis was associated with a better prognosis (adjusted hazard ratio, 0.29; P= .006). Two severe adverse events were noted. TC-325 was safe and effective for intraprocedural hemostasis in more than 90% of patients, regardless of the cause or site of bleeding and its use as rescue therapy. In this high-risk cohort treated with TC-325, the 30-day failure rate exceeded 25% and was highest with spurting bleeding or hemodynamic instability.

Efficacy of a novel endoscopically deliverable muco-adhesive hemostatic powder in an acute gastric bleeding porcine model.

This study investigated the effectiveness of new hemostatic adhesive powder (UI-EWD) in a swine mode of acute gastric bleeding. Gastric ulcer bleeding was induced endoscopically at two locations in each of eight heparinized mini-pigs. UI-EWD and saline were sprayed endoscopically in the experimental (n = 5) and control groups (n = 3), respectively. The hemostatic effect and hydrogel persistence on ulcers were periodically evaluated endoscopically. Initial hemostasis was achieved successfully in all lesions in the experimental group. Follow-up endoscopy showed minor delayed bleeding in 10% at 6 hours in the experimental group, whereas re-bleeding was observed in 50% at 6 hours in the control group. UI-EWD gel persisted at 90%, 80%, and 50% of ulcer bases at 6, 18, and 42 hours post-application, respectively. This study suggests that muco-adhesive UI-EWD may be effective in the endoscopic treatment of active ulcer bleeding.

Alternative approach to hemostatic particle spraying for treatment of GI bleeding by the use of cross-platform devices.

Background and AimsGI bleeding is a leading cause of morbidity and mortality in the United States, with an estimated 20,000 deaths per year. Some subgroups of patients show refractory recurrent bleeding despite standard endoscopic therapy. The U.S. Food and Drug Administration has recently approved a hemostatic spray for clinical use in nonvariceal bleeding. Despite its efficacy, not all endoscopy units have access to this spray, at times because of cost. Our aim was to determine the safety and efficacy of a plant-based hemostatic particle spray in nonvariceal GI bleeding by use of a cross-platform setup.MethodWe present 3 cases in which plant-based particle spray was used for hemostasis with a cross-platform delivery system. Conventional therapies failed in the first 2 cases, and in the third case hemostatic particle spray was used as a primary therapy.ResultsSuccessful immediate hemostasis was achieved in all 3 patients. No immediate adverse events or recurrence of bleeding was noted.ConclusionsPlant-based hemostatic particle spray is safe and effective as a temporizing measure in refractory ulcer and postnecrosectomy cavity bleeding. Further studies are needed to establish the safety and comparative efficacy of plant-based hemostatic powder. The cross-platform system used here for plant-based hemostatic particle spray presents a less-expensive alternative in selected cases.

Video Comment on Jin-Seok Park et al.

Jin-Seok Park et al. Efficacy of a novel hemostatic adhesive powder in patients with refractory upper gastrointestinal bleeding: a pilot study

Early application of haemostatic powder added to standard management for oesophagogastric variceal bleeding: a randomised trial

BackgroundAcute variceal bleeding (AVB) requires early therapeutic management by experienced endoscopists that often poses logistical challenges for hospitals. We assessed a different management concept with early application of haemostatic powder—which...

Hemostatic powder facts.

Hemostatic powder facts.

Response.

We thank Wagner and Gittard1Wagner D.R. Gittard S. Hemostatic powder facts.VideoGIE. 2019; 4: 185Abstract Full Text Full Text PDF Scopus (1) Google Scholar for the opportunity to clarify our statement about known adverse events associated with hemostatic powder. Our VideoGIE abstract details the step-by-step use of hemostatic powder highlighting a case of a bleeding GI stromal tumor recalcitrant to other endoscopic hemostatic techniques, successfully bridged to definitive surgical therapy.2Storm A.C. Sawas T. Higgins T. et al.Step-by-step use of hemostatic powder: treatment of a bleeding GI stromal tumor.VideoGIE. 2019; 4: 5-6Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar The commenters are correct in stating that colonic obstruction has not been reported for the device used in the video (Hemospray; Cook, Winston-Salem, NC, USA). Bowel obstruction has been reported with other surgical hemostatic matrices,3Clapp B. Santillan A. Small bowel obstruction after FloSeal use.JSLS. 2011; 15: 361-364Crossref PubMed Scopus (21) Google Scholar and we, therefore, believe it remains a theoretic risk to consider in the treatment of patients who have recently undergone hemostatic powder treatment. To mitigate this risk, the company recommends limiting the number of devices to 3, or 60 grams of bentonite powder in total, within a single session. It is worth mentioning that 1 study of the device, sometimes with the use of doses more than twice the currently recommended dose, did not report any occurrence of bowel obstruction.4Sung J.J. Luo D. Wu J.C. et al.Early clinical experience of the safety and effectiveness of hemospray in achieving hemostasis in patients with acute peptic ulcer bleeding.Endoscopy. 2011; 43: 291-295Crossref PubMed Scopus (177) Google Scholar As we previously mentioned, biliary obstruction and perforation are adverse events previously reported with the use of hemostatic powder.5Moosavi S. Chen Y.I. Barkun A.N. TC-325 application leading to transient obstruction of a postsphincterotomy biliary orifice.Endoscopy. 2013; 45: E130Crossref PubMed Scopus (19) Google Scholar, 6Smith L.A. Morris A.J. Stanley A.J. The use of hemospray in portal hypertensive bleeding: a case series.J Hepatol. 2014; 60: 457-460Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar, 7Yau A.H. Ou G. Galorport C. et al.Safety and efficacy of hemospray in upper gastrointestinal bleeding.Can J Gastroenterol Hepatol. 2014; 28: 72-76Crossref PubMed Scopus (60) Google Scholar, 8Hagel A.F. Albrecht H. Nagel A. et al.The application of hemospray in gastrointestinal bleeding during emergency endoscopy.Gastro Res Pract Epub. 2017 Jan 23; Google Scholar As such, we stand by our warning for the theoretic risk of cholangitis, particularly if hemostatic powder is used in or near the biliary orifice, and would advise caution when considering use of the device in these areas. Hemostatic powder factsVideoGIEVol. 4Issue 4PreviewWe read with interest the VideoGIE article by Storm et al1 from Mayo Clinic Rochester. The case shows the unique benefits of Hemospray in offering durable hemostasis for bleeding that is resistant to conventional treatments, even in the setting of dual antiplatelet therapy. We commend the authors for their persistence in providing a positive outcome for this patient. However, we noted several errors that should be corrected because they do not accurately reflect the potential adverse events that may result from Hemospray treatment. Full-Text PDF Open Access

Treatment of gastrointestinal bleeding with hemostatic powder (TC-325): a multicenter study

Hemostatic powder (TC-325) is a new tool for treatment of gastrointestinal bleeding that allows the treatment of large surfaces with active bleeding. The aim was to describe the initial success of TC-325 for the control of GI bleeding. We did a multicenter cohort study with patients admitted to the endoscopy service for GI bleeding. A format was generated to standardize the information obtained in each center. It was determined whether this treatment had been used as a single therapy or as a combination therapy. Descriptive statistics with medians and ranges, or averages with SD according to distribution. Eighty-one patients with 104 endoscopic procedures were included. The median number of endoscopic procedures was 1 (1-3). In the first procedure, the initial success rate was 98.8% (n = 80), failure rate was 1.2% (n = 1), and rebleeding rate was 20% (n = 16). The majority of rebleeding cases occurred within the first 3 days (12/16, 75%). There was no association between rebleeding and etiology (malignant or benign; P = 0.6). In first procedure, 44 (54%) cases had monotherapy with TC-325 and 37 (46%) cases had a combined endoscopic therapy. There were no differences in initial success or rebleeding rates when TC-325 was used as monotherapy versus combined therapy (P = 0.7). The mortality rate was 4% (3/81). TC-325 is effective for achieving initial control of bleeding in patients with different GI etiologies. The rate of bleeding recurrence is considerable in both patients with benign and malignant etiology.

Reduction of lymphocele rate in patients undergoing sentinel node biopsy for melanoma by intraoperative placement of plant-based hemostatic powder: Results of a prospective trial

BackgroundLymphocele is a complication of sentinel node biopsy (SNB) for melanoma. Plant-based hemostatic powder (PBHP) may have a lymphostatic benefit. We studied whether PBHP placed intraoperatively could reduce lymphocele rates. MethodsWe performed an open label, prospective, IRB -approved, before- and-after, matched control trial of PBHP placed into the wound in patients undergoing SNB of groin or axillary nodes for melanoma staging. Patient/tumor features and lymphocele rates were compared by standard statistical tests. Results66 control and 66 treatment (49 axillary and 17 groin in each arm) SNBs were performed in 61 and 55 patients, respectively, for a total 132 SNBs in 116 patients. Patient and tumor features were similar between groups. Nineteen lymphoceles occurred (14.4%); lymphocele rates were 22.2% (14/66) in the control group and 7.6% (5/66) in the treatment group (p = 0.026). The reduction in lymphocele rates between arms was greater for axillary than for groin sites (87.5% vs. 33%); the axillary reduction was statistically significant (p = 0.030). ConclusionsIntra-operative placement of PBHP reduced the rate of lymphoceles in patients undergoing SNB for melanoma.

Hemospray hemostasis in bleeding diffusely ulcerated esophagus.

Background and AimsBleeding from diffuse esophageal ulcerations can be difficult to treat. Hemospray is a hemostatic powder, and its mechanism of hemostasis is thought to be through concentrating clotting factors and forming mechanical plugs on bleeding vessels.MethodsThe authors present 3 consecutive cases of diffusely ulcerated esophagus with clinically significant bleeding. The first 2 cases failed conventional hemostatic treatment including clipping and injection therapy. In the third case, Hemospray was used as the first-line monotherapy.ResultsImmediate hemostasis was achieved in all 3 patients, and they did not develop recurrent bleeding for more than 2 months.ConclusionsThe authors propose that Hemospray application should be considered as the first-line therapy in diffuse esophageal ulcerations with clinically significant bleeding, potentially reducing the need to repeat endoscopy. Once the Hemospray achieves hemostasis, it provides a cyto-protective barrier on the diffusely ulcerated mucosa against ongoing acid reflux, allowing the new tissue to grow more efficiently during the ulcer healing period.

Efficacy of a novel hemostatic adhesive powder in patients with refractory upper gastrointestinal bleeding: a pilot study.

A new hemostatic adhesive powder (UI-EWD) has been developed to reduce the high re-bleeding rates associated with the currently available hemostatic powders. The current study aimed to assess the efficacy of UI-EWD as a salvage therapy for the treatment of refractory upper gastrointestinal bleeding (UGIB). A total of 17 consecutive patients who had failed to achieve hemostasis with conventional endoscopic procedures and had undergone treatment with UI-EWD for endoscopic hemostasis in refractory UGIB were prospectively enrolled in the study. We evaluated the success rate of initial hemostasis and rate of re-bleeding within 30 days. All patients underwent successful UI-EWD application at the bleeding site. Initial hemostasis occurred in 16/17 patients (94 %). Re-bleeding within 30 days occurred in 3/16 patients (19 %) who had achieved initial hemostasis. In the second-look endoscopy after 24 hours, hydrogel from UI-EWD was found attached at the bleeding site in 11/16 patients (69 %). UI-EWD has a high success rate for initial hemostasis in refractory UGIB and shows promising results in the prevention of re-bleeding.

Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale.

The safety and efficacy of a hemostatic powder (HP) versus a control agent, absorbable gelatin sponge and thrombin (G + T), were assessed, using a validated, quantitative bleeding severity scale. Subjects were randomized to receive HP (256 subjects) or G + T (132 subjects) for treatment of minimal, mild, or moderate bleeding at 20 investigational sites. The primary efficacy endpoint was non-inferiority of HP relative to G + T for success at achieving hemostasis within 6 minutes. Secondary endpoints in rank order included: superiority of HP relative to G + T in mean preparation time; non-inferiority of HP relative to G + T for achieving hemostasis within 3 min; superiority of HP relative to G + T for achieving hemostasis within 6 min; and superiority of HP relative to G + T for success for achieving hemostasis within 3 min. A total of 388 subjects were included in the primary efficacy analysis. At 6 min, hemostasis was achieved in 93.0% (238/256) of the HP group compared to 77.3% (102/132) of the G + T group (non-inferiority P < 0.0001, superiority P < 0.0001). All secondary endpoints were met. Complications were comparable between treatment groups. HP had superior rates of hemostasis, shorter preparation time, and a similar safety profile compared to G + T in this prospective, randomized trial using quantitative bleeding severity criteria.

Successful hemostasis of active lower GI bleeding using a hemostatic powder as monotherapy, combination therapy, or rescue therapy

Acute lower GI bleeding is a frequent cause of hospital admission. The objective of this study was to evaluate the safety and performance of a hemostatic powder (TC-325/Hemospray) in the treatment of nonvariceal lower GI bleeding. Patients were enrolled into this prospective, multicenter, single-arm study at 4 tertiary care centers in Canada. Fifty patients with active lower GI bleeding of multiple different causes (52 bleeding sites) underwent topical endoscopic application of hemostatic powder. The primary endpoint was powder-related adverse events within 30 days of the index procedure. Secondary endpoints were initial hemostasis as well as recurrent bleeding and mortality within 30 days of the index procedure. Most patients (96%) had a single bleeding site, and most bleeding (73%) was due to polypectomy. Overall, the powder was applied as monotherapy in 13 bleeding sites (25%), as combination therapy in 22 bleeding sites (42.3%), and as rescue therapy in 17 bleeding sites (32.7%). Hemostasis was achieved in 98% of patients. No patient experienced a powder-related adverse event. Five patients (10%) developed recurrent bleeding within 30 days. One patient (2%) died within 30 days of powder application, but the death was not directly related to hemostatic powder use. The hemostatic powder is a safe and effective option for patients with lower GI bleeding of varying causes, and in particular, postpolypectomy hemorrhage. The hemostatic powder is effective as monotherapy, part of a combination approach, or as a rescue therapeutic option for the treatment of nonvariceal lower GI bleeding. (Clinical trial registration number: NCT02099435.).