Hemostatic Spray Powder TC-325 for Primary Endoscopic Treatment of Peptic Ulcer–Related Bleeding

Hemospray (Tc-325), the most commonly used hemostatic powder, was used in a multicenter registry prospectively assessing 202 patients with peptic ulcer bleeding  (most Forrest Ib 58% or Ia 19%). Immediate hemostasis rates (defined as within 5 minutes of Hemospray application) were 85% in Forrest I patients (87% in Ia and 85% in Ib). Overall, 30-day rebleeding was 17%; the 30-day all-cause mortality rate was 22%. A total of 50 patients (25%) received Hemospray as monotherapy, 101 (50%) as part of combination, and 51 (25%) as rescue therapy. There were no differences in outcomes among the three groups except for a lower 30-day mortality rate in the combination group (16%). These data further confirm Hemospray endotherapy feasibility and effectiveness in achieving immediate hemostasis. Its role as monotherapy in peptic ulcer bleeding  remains unclear as the included IIa and IIb patients would not expect to benefit from Hemospray as no active bleeding lesions present for the product to bind to. 

PuraStat (3D-Matrix Europe Ltd., France) is a novel synthetic self-assembling peptide that is a transparent gel formulation; it forms an extracellular scaffold matrix when activated by the change in pH that occurs upon contact with blood, thus providing a stable mechanical barrier over the bleeding site. Publications on its use have principally targeted intraprocedural bleeding, with some data suggesting accelerated healing properties. The present study is a single blinded randomized controlled trial of 101 patients undergoing endoscopic submucosal dissection (ESD) for 2- to 5-cm lesions treated in the esophagus or colon. Randomized patients received PuraStat or diathermy for grades 1/2 intraprocedural bleeding outside the immediate vicinity of the tip of the knife, or when the bleeding point was not easily accessible to diathermy. Routine end-of-procedure complete coverage of the resection base was achieved in all PuraStat patients. Significant reduction in the use of heat was noted in the PuraStat group compared with controls (49.3% vs 99.6%; P < .001). There were no differences in procedure length, time to achieve hemostasis, early rebleeding, or delayed bleeding up to 4 weeks. Complete wound healing at 4 weeks was more frequent in PuraStat patients (48.8% vs 25.0%; P = .02), a finding limited to colonic lesions. Small amounts of PuraStat were required (hemostasis = 0.43 mL per bleed, and prophylactic resection base coverage = 2.03 mL per patient). PuraStat was easy to apply and interfered with visibility in only 2 patients. The cost-effectiveness of this approach was not assessed. Additional adequately controlled studies are required to confirm these findings and better define their clinical relevance that could translate into a safer procedure with fewer post-ESD electrocoagulation syndromes and perforations. PuraStat is a promising topical agent, providing rapid hemostasis and potentially accelerating tissue healing.

References

1. Hussein M, Alzoubaidi D, Lopez MF, et al. Hemostatic spray powder TC-325 in the primary endoscopic treatment of peptic ulcer-related bleeding: multicenter international registry. Endoscopy. 2021;53(1):36-43. https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-1186-5360
2. Subramaniams, Kandiah K, Chedgy F, et al. A Novel Self-Assembling Peptide for Hemostasis During Endoscopic Submucosal Dissection: A Randomized Controlled Trial. Endoscopy 2021;53(01):27-35. https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-1198-0558