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

Published:August 19, 2019DOI:https://doi.org/10.1016/j.gie.2019.08.005

      Background and Aims

      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.

      Methods

      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.

      Results

      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).

      Conclusions

      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.)

      Graphical abstract

      Abbreviations:

      CI (confidence interval), SOC (standard of care)
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      Linked Article

      • Role of TC-325 in GI tumor hemostasis
        Gastrointestinal EndoscopyVol. 92Issue 3
        • Preview
          We read with great interest the article “TC-325 hemostatic powder versus current standard of care (SOC) in managing GI bleeding: a pilot randomized clinical trial” by Chen et al,1 published in Gastrointestinal Endoscopy. In their pilot trial, the authors concluded that TC-325 demonstrated promising results in achieving hemostasis in malignant GI bleeding lesions.
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      • Is hemospray the ultimate answer to malignant GI bleeding?
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          TC-325 (Hemospray, Cook Medical, Winston-Salem, North Carolina, USA) is a propriety mineral blend powder developed for the purpose of endoscopic hemostasis. The powder was originally approved for use in stopping bleeding from external wounds in both civilian and military injuries. In 2011, our group reported its first endoscopic application in patients with actively bleeding peptic ulcers.1 The powder was sprayed onto the bleeding vessel with the use of a pressurized carbon dioxide canister. In 19 of 20 patients, hemostasis was achieved.
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        • PDF