A new, multi-centre study on Cook Medical’s Hemospray Endoscopic Hemostat device has revealed that the use of Hemospray demonstrated a more than 98% successful hemostasis rate, while the 30-day rebleeding rate was 10%. The results, ‘Successful hemostasis of active lower GI bleeding using a hemostatic powder as monotherapy, combination therapy, or rescue therapy’, were published in the April 2019 edition of Gastrointestinal Endoscopy. These results provide support for the safety of haemostatic powder when used to treat patients with gastrointestinal bleeding in the lower GI tract.
The prospective, non-randomised, Cook sponsored APPROACH (A Prospective Observational Cohort Study of Hemospray for Lower Gastrointestinal Hemorrhage) study was conducted at four tertiary care centres in Canada and involved 50 patients with a total of 52 active bleeding sites in the lower gastrointestinal tract. Hemospray is an inert, bentonite powder developed for endoscopic haemostasis and is used for haemostasis of non-variceal gastrointestinal bleeding. The objective of the study was to evaluate the safety and performance of a haemostatic powder (TC-325/Hemospray) in the treatment of nonvariceal lower GI bleeding.
The study, titled “Successful hemostasis of active lower GI bleeding using a haemostatic powder as monotherapy, combination therapy, or rescue therapy,” authored by Dr Lawrence Hookey and colleagues, sought to identify powder-related adverse events within 30 days of the index procedure, as well as recurrent bleeding and mortality within 30 days of the index procedure.
The paper reported that 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%). Haemostasis was achieved in 98% of patients and no patients experienced a powder-related adverse event. Five patients (10%) developed recurrent bleeding within 30 days and one patient (2%) died within 30 days of powder application, but the death was not directly related to haemostatic powder use.
“The haemostatic powder is a safe and effective option for patients with lower GI bleeding of varying causes, and in particular, postpolypectomy haemorrhage,” the paper concluded. “The haemostatic powder is effective as monotherapy, part of a combination approach, or as a rescue therapeutic option for the treatment of nonvariceal lower GI bleeding.”
“The new data further demonstrates the potential for applications of Hemospray to treat patients with GI bleeds, wherever the occur,” said Barry Slowey, vice president of Cook Medical’s Endoscopy business.