Variceal HemorrhageNCT03061604
RCT to Determine the Efficacy of Combining Hemospray With Medical Treatment in Acute Variceal Bleeding
A study testing Hemospray, Octreotide and Blood transfusion in people with Variceal Hemorrhage, run by Theodor Bilharz Research Institute at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Variceal Hemorrhage
- What is being tested?
- Hemospray, Octreotide and Blood transfusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
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.
Read more
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).
Read the 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
- Being tested
- Hemospray, Octreotide, Blood transfusion, Ceftriaxone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemosprayDevice
Also called Hemostatic Powder
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
OctreotideDrug
Also called Vasoactive 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
Blood transfusionBiological
Blood transfusion will be administered to all patients if needed
CeftriaxoneDrug
Also called Antibiotics
Ceftriaxone will be administered to all patients on daily basis
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Octreotide; Biological: Blood transfusion; Drug: Ceftriaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemostasis
which is a combined endpoint of Endoscopic hemostasis at (12-24) hours and Clinical hemostasis during (12-24) hours.
Measured: 24 hours
Secondary outcomes (4)
Need for rescue endoscopy
Measured: 12 hours
Survival
Measured: 5 days
Survival
Measured: 15 days
Survival
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startNov 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Variceal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Responsible party
- Principal investigator, Mostafa Ibrahim, Theodor Bilharz Research Institute
- Investigators
- Jacques Deviere, PHD, Study director, Erasme Hospital , Université libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061604
- Sponsor's protocol ID
- Hemospray Varices RCT
- Status last verified
- Nov 2017
- First submitted
- 30 Nov 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: If data will be shared to other researchers , The patients personal data will be removed
Publications
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.
PubMed 29730601
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03061604
- Acronym / sponsor ID
- Hemospray Varices RCT
- Conditions
- Variceal Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Study start
- Nov 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemospray | Experimental | Device: Hemospray, Drug: Octreotide, Biological: Blood transfusion, Drug: CeftriaxoneAll 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). |
| Non Hemospray | Active comparator | Drug: Octreotide, Biological: Blood transfusion, Drug: CeftriaxoneAll 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Patient is: < 18 years of age
- Unable to consent
- Contraindicated to undergo endoscopy,
- Already hospitalized for another illness
- Pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemosprayAlso: Hemostatic PowderHemospray 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 | Device | Hemospray |
| OctreotideAlso: Vasoactive drugOctreotide 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 | Drug | Hemospray, Non Hemospray |
| Blood transfusionBlood transfusion will be administered to all patients if needed | Biological | Hemospray, Non Hemospray |
| CeftriaxoneAlso: AntibioticsCeftriaxone will be administered to all patients on daily basis | Drug | Hemospray, Non Hemospray |
Primary outcome
Haemostasis
Time frame: 24 hours
which is a combined endpoint of Endoscopic hemostasis at (12-24) hours and Clinical hemostasis during (12-24) hours.
4 secondary outcomes
Need for rescue endoscopy
Time frame: 12 hours
Survival
Time frame: 5 days
Survival
Time frame: 15 days
Survival
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Derived from this study: PubMed 29730601Ibrahim 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.
- Individual participant dataSharing planned: Undecided. If data will be shared to other researchers , The patients personal data will be removed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Deviere, PHD study director
Erasme Hospital , Université libre de Bruxelles
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemospray, Octreotide and Blood transfusion in people with Variceal Hemorrhage, run by Theodor Bilharz Research Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemostasis (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.