NCT03061604

RCT to Determine the Efficacy of Combining Hemospray With Medical Treatment in Acute Variceal Bleeding

A Randomized Control Study to Determine the Efficacy and Safety of Combining Hemospray With Medical Standard of Care Treatment in the Management of Acute Variceal Bleeding in Cirrhotic Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Theodor Bilharz Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

STUDY ENDPOINTS : 1.1. Primary endpoint: Hemostasis is the primary end point: which is a combined endpoint of Endoscopic hemostasis at (12-24) hours and Clinical hemostasis during (12-24) hours. 1.2. Secondary endpoints: * Need for rescue endoscopy (Before 12h) * Safety * Interaction with coagulation profile * Rebleeding at 5 days. * Survival at 5 days * Survival at 30 days

Conditions

• Variceal Hemorrhage

Interventions

Type	Name	Description
DEVICE	Hemospray	Hemospray is a novel hemostatic powder licensed for endoscopic hemostasis of non-variceal upper gastrointestinal bleeding which has been shown to be effective in preliminary studies for the management of patients with peptic ulcer bleeding, including those on anticoagulant or antithrombotic therapy . Recently, two case reports and a pilot study reported that hemostatic powder may be useful in emergency management of variceal bleeding as a bridge towards more definitive therapy
DRUG	Octreotide	Octreotide will be administered to all patients at time of admission and will be continued for 24 hours • Dosage: 50 mcg bolus at admission then 25 mcg/hour
BIOLOGICAL	Blood transfusion	Blood transfusion will be administered to all patients if needed
DRUG	Ceftriaxone	Ceftriaxone will be administered to all patients on daily basis

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2017-02-23
• Last updated: 2017-11-14

Locations

2 sites across 2 countries: Belgium, Egypt