Clinical trial NCT03061604: RCT to Determine the Efficacy of Combining Hemospray With Medical Treatment in Acute Variceal Bleeding
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Variceal Hemorrhage
Lead sponsor: Theodor Bilharz Research Institute
Sponsor class: OTHER
Collaborators: name: Université Libre de Bruxelles
First posted: 2017-02-23
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* Subject must be over 18 years of age.
* Suspected or proven acute variceal bleeding , Gastric lavage will be done for all patients at admission (Acute bleeding is confirmed on the presence of blood in stomach)
* Subjects must be willing to give written informed consent for the trial
* Known or suspected cirrhosis

Exclusion Criteria:

* Patient is: \< 18 years of age
* Unable to consent
* Contraindicated to undergo endoscopy,
* Already hospitalized for another illness
* Pregnant or lactating
* Patients with altered post-surgical anatomy of the stomach
* Previously placed intrahepatic portosystemic shunt
* Patient treated by other endoscopic or surgical modalities within 30 days prior to the intended application of Hemospray

Primary outcomes:
measure: Haemostasis
timeFrame: 24 hours
Secondary outcomes:
measure: Need for rescue endoscopy
timeFrame: 12 hours
measure: Survival
timeFrame: 5 days
measure: Survival
timeFrame: 15 days
measure: Survival
timeFrame: 30 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital , ULB
city: Giza
country: Egypt
facility: Theodor Bilharz Research Institute
Study officials:
affiliation: Erasme Hospital , Université libre de Bruxelles
name: Jacques Deviere, PHD
role: STUDY_DIRECTOR
References:
citation: Ibrahim M, El-Mikkawy A, Abdel Hamid M, Abdalla H, Lemmers A, Mostafa I, Deviere J. Early application of haemostatic powder added to standard management for oesophagogastric variceal bleeding: a randomised trial. Gut. 2019 May;68(5):844-853. doi: 10.1136/gutjnl-2017-314653. Epub 2018 May 5.