RCT to Determine the Efficacy of Combining Hemospray With Medical Treatment in Acute Variceal Bleeding
NCT ID: NCT03061604
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2014-11-30
2017-11-30
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hemospray
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).
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
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
Blood transfusion
Blood transfusion will be administered to all patients if needed
Ceftriaxone
Ceftriaxone will be administered to all patients on daily basis
Non Hemospray
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).
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
Blood transfusion
Blood transfusion will be administered to all patients if needed
Ceftriaxone
Ceftriaxone will be administered to all patients on daily basis
Interventions
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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
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
Blood transfusion
Blood transfusion will be administered to all patients if needed
Ceftriaxone
Ceftriaxone will be administered to all patients on daily basis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Université Libre de Bruxelles
OTHER
Theodor Bilharz Research Institute
OTHER
Responsible Party
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Mostafa Ibrahim
Principal Investigator
Principal Investigators
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Jacques Deviere, PHD
Role: STUDY_DIRECTOR
Erasme Hospital , Université libre de Bruxelles
Locations
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Erasme Hospital , ULB
Brussels, , Belgium
Theodor Bilharz Research Institute
Giza, , Egypt
Countries
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References
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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.
Other Identifiers
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Hemospray Varices RCT
Identifier Type: -
Identifier Source: org_study_id