RCT to Determine the Efficacy of Combining Hemospray With Medical Treatment in Acute Variceal Bleeding
Status:
Completed
Trial end date:
2017-11-01
Target enrollment:
Participant gender:
Summary
INTRODUCTION Acute variceal bleeding (AVB) is a severe complication of portal hypertension in
patients with liver cirrhosis. The primary therapy includes the administration of vasoactive
drugs, antibiotics and endoscopic therapy; preferably esophageal banding ligation (EBL)
and/or cyanoacrylate injection when bleeding occurs from gastric varices.
In this context, the idea is to assess "Hemospray" (Cook Medical, Winston-Salem, NC) as an
initial therapy in patients with massive bleeding as a temporary "bridge" until definitive
treatment could be instituted.
The data generated from the pilot study performed between Erasme hospital, ULB and TBRI ,
Cairo showed that adding Hemospray as early as possible in the management steps could
increase the bleeding control rate up to 95 % at 24 hours.
OBJECTIVE The primary efficacy objective of this study is to assess the efficacy of Hemospray
in combination with standard of care (SOC) medical treatment compared to the efficacy of SOC
in the Control Arm in patient with acute variceal bleeding in cirrhotic patient.
The primary safety objective of this study is to evaluate the safety of Hemospray when used
in combination with SOC compared to SOC in the Control Arm.
1.1. Secondary:
- To evaluate the effect of timing of Hemospray treatment on the outcomes of bleeding
patients
- To evaluate the adverse effects on both therapeutic regimens (SAEs and clinically
significant AEs).