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

Variceal Hemorrhage Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03061604
• Other study ID #: Hemospray Varices RCT
• Status: Completed
• Phase: N/A
• First received: November 30, 2016
• Last updated: November 9, 2017
• Start date: November 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Theodor Bilharz Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Variceal Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Belgium	Erasme Hospital , ULB	Brussels
Egypt	Theodor Bilharz Research Institute	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Theodor Bilharz Research Institute	Université Libre de Bruxelles

Countries where clinical trial is conducted

Belgium,  Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemostasis	which is a combined endpoint of Endoscopic hemostasis at (12-24) hours and Clinical hemostasis during (12-24) hours.	24 hours
Secondary	Need for rescue endoscopy		12 hours
Secondary	Survival		5 days
Secondary	Survival		15 days
Secondary	Survival		30 days