PuraStat® is a novel gel that offers several advantages over traditional hemostatic powders. Its transparency allows for continuous visualization of the bleeding site, and it can be applied in narrow spaces or in combination with other treatments. Additionally, the pre-filled syringe design ensures ease of handling and precise delivery.
Most published data on PuraStat® as a hemostatic agent originates from surgical settings. In endoscopy, its primary applications have been in polypectomy-related hemostasis and the promotion of wound healing. Reports indicate a hemostasis success rate of 90.4%, with a recurrence rate of 10.4%.
Limited data exist regarding the efficacy of PuraStat® as a hemostatic agent in upper gastrointestinal bleeding (UGIB) lesions. This study hypothesizes that PuraStat®, when combined with Adrenaline, serves as a feasible and effective first-line treatment for gastrointestinal bleeding. To evaluate this, a prospective, randomized, parallel-group, open-label clinical trial is proposed.
Age >18 years
Undergoing endoscopic therapy for non-variceal gastrointestinal bleeding
Variceal or portal hypertension-related gastrointestinal bleeding
Lack of signed consent form
Pregnancy or breastfeeding
Parallel
PuraStat® combined with Adrenaline
Combination productPuraStat® application (mL) combined with Adrenaline injection (mL)
Standard of Care
Combination productAdrenaline injection + second hemostasis modality (contact thermal, mechanical therapy, or injection of a sclerosing agent).
Clinical success
Absence of rebleeding (recurrence of haematemesis, maelena and /or haematochezia, recurrent tachycardia or hypotension after achieving hemodynamic stability, or a reduction in haemoglobin ≥ 2 g/dL after a stable haemoglobin value has been attained) observed within the first 4 weeks following the initial endoscopic treatment.
Technical success
Ability to achieve haemostasis and/or complete the endoscopic treatment satisfactorily
Duration of the procedure
From the bleeding lesion is detected until the end of the endoscopic treatment.
Level of difficulty
Graded in three categories: Very Easy (no difficulties encountered and no effort needed), Easy (mild difficulties and mild effort needed), Difficult (difficulties encountered and a considerable effort needed or Very Difficult (high difficulties and high effort or skills needed to treat the lesion
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