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

NCT03061604 | Completed DMC

• 1 other identifier: Hemospray Varices RCT
• Study Type: interventional
• Target: 105
• Locations: 2 countries
• Sites: 2

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).

Conditions

Variceal Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Haemostasis

  which is a combined endpoint of Endoscopic hemostasis at (12-24) hours and Clinical hemostasis during (12-24) hours.

  24 hours

Secondary Outcomes (4)

• Need for rescue endoscopy

  12 hours

• Survival

  5 days

• Survival

  15 days

• Survival

  30 days

Study Arms (2)

Hemospray

EXPERIMENTAL

All subjects will be treated by medical treatment in the terms of combination of vasoactive medication, blood transfusion and Ceftriaxone PLUS Hemospray treatment within 2 hours of admission. The medical treatment will be continued till 12 hours after admission and then second endoscopy will be performed (12-24 hours after admission).

Device: Hemospray; Drug: Octreotide; Biological: Blood transfusion; Drug: Ceftriaxone

Non Hemospray

ACTIVE COMPARATOR

All subjects will be treated by medical treatment in the terms of combination of Octreotide, blood transfusion and Ceftriaxone. The medical treatment will be continued till 12 hours after admission and then second endoscopy will be performed (12-24 hours after admission).

Drug: Octreotide; Biological: Blood transfusion; Drug: Ceftriaxone

Interventions

Hemospray DEVICE

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

Also known as: Hemostatic Powder

Hemospray

Octreotide DRUG

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

Also known as: Vasoactive drug

Hemospray; Non Hemospray

Blood transfusion BIOLOGICAL

Blood transfusion will be administered to all patients if needed

Hemospray; Non Hemospray

Ceftriaxone DRUG

Ceftriaxone will be administered to all patients on daily basis

Also known as: Antibiotics

Hemospray; Non Hemospray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead
• Université Libre de Bruxelles: collaborator

Study Sites (2)

Erasme Hospital , ULB

Brussels, 1070, Belgium

Location

Theodor Bilharz Research Institute

Giza, 12311, Egypt

Location

Related Publications (1)

• 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.

  PMID: 29730601 DERIVED

MeSH Terms

Interventions

Octreotide; Blood Transfusion; Ceftriaxone; Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Biological Therapy; Therapeutics; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jacques Deviere, PHD

  Erasme Hospital , Université libre de Bruxelles

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: February 23, 2017
• Study Start: November 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

EG (1); BE (1)