Hemospray® (Hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multi-center prospective study

Abstract

Abstract Background Topical hemostatic powders are a reliable second-line approach in acute gastrointestinal (GI) bleeding (AGIB) treatment, according to the existing guidelines. Increasing evidence supports the use of hemostatic powder TC-325 (Hemospray®) as monotherapy in specific GI bleeding scenarios. This prospective, multi-center study evaluated the performance of TC-325 as monotherapy for GI hemorrhage. Methods Eighteen centres across Europe, and USA contributed between 2016 and 2022 to an international multicentre prospective registry. Adults with AGIB were eligible (melena, hematemesis, hematochezia, Glasgow-Blatchford score ≥ 1 or abnormal Oakland score), unless TC-325 was part of combined hemostasis (adjunctive to clips or thermocautery). The primary endpoint was immediate haemostasis. Secondary outcomes were rebleeding, 7- and 30-day mortality rates. Potential associations with risk factors were investigated with statistical significance set for p ≤ 0.05. Results One hundred and ninety patients were included (age range = 51–81, male:female = 2:1). Peptic ulcer (n = 48), upper GI malignancy (n = 79), post endoscopic treatment-related hemorrhage (n = 37), and lower GI lesions (n = 26) were diagnosed. The primary outcome was recorded in 96.3% (95%CI:92.6–98.5) with rebleeding in 17.4% (95%CI:11.9–24.1) when TC-325 was used as primary monotherapy. Post-hemostasis, 9.9% (95%CI:5.8–15.6) died within 7 days and 21.7% (95%CI:15.6–28.9) within 30 days. Regarding peptic ulcer, the immediate hemostasis was achieved in 88% (95%CI:75–95) and 26% (95%CI:13–43) rebled. Increased American Society of Anaesthesiologists (ASA) score was associated with mortality [OR:23.5 (95%CI:1.60–345); p = 0.02]. The primary outcome was achieved in 100% of cases with malignancy and post GI intervention bleeding, with rebleeding in 17% and 3.1%, respectively. Twenty-six patients received Hemospray® for lower GI bleeding, and in all but one the primary outcome was achieved. Conclusions TC-325 powder as monotherapy represents a safe and effective modality especially in malignancy- or post-endoscopic intervention-related bleeding. In peptic ulcer bleeding it could be helpful when the standard of care treatment is not feasible or unavailable, to stabilise patients.