PuraStat® Combined With Adrenaline Versus Standard of Care in Upper Gastrointestinal Bleeding

Condition(s) studied

Investigational drug(s) / intervention(s)

PuraStat® combined with Adrenaline: PuraStat® application (mL) combined with Adrenaline injection (mL)

Standard of Care: Adrenaline injection + second hemostasis modality (contact thermal, mechanical therapy, or injection of a sclerosing agent).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Clinical success — 30 days
  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.

Trial sites (1)