- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02135627
TC-325 (HEMOSPRAY™) VS. CURRENT STANDARD OF CARE IN MANAGING MALIGNANT GASTROINTESTINAL BLEEDING: A PILOT STUDY TO INFORM A RANDOMIZED CONTROLLED TRIAL.
November 21, 2016 updated by: Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre
Introduction: Gastrointestinal (GI) bleeding arising from malignant tumors is increasingly recognized as a result of oncological advances and improved detection methods, and stems from local vessel damage and tumor invasion with associated derangements in the hemostatic system(1, 2).
Although conventional endoscopic hemostasis methods improve outcomes in UGIB due to peptic ulcers and other non-variceal benign bleeding lesions of the upper, and perhaps the lower GI tract, data on their use in hemorrhagic, upper or lower gastrointestinal neoplasms are scarce and associated with varying success in initial hemostasis and high rebleeding rates(3-7).
Other recognized single or multimodality treatment approaches include radiation therapy, interventional angiography, and surgery.
All exhibit disappointing rebleeding rates, and in the case of emergency surgery, high mortality(4, 8-11).
Challenges associated with bleeding tumors include hematological derangements such as thrombocytopenia, disseminated intravascular coagulation, and neutropenia, as well as the endoscopic manipulation of friable, diffusely bleeding surfaces when attempting hemostasis(2, 12, 13).
The recent advent of TC-325 (HemosprayTM) to Canada, Europe and Asia - referred henceforth as TC-325 - may provide a highly adapted novel endoscopic hemostatic therapeutic alternative for this refractory clinical entity, with promising uncontrolled observations having just been published by our group(13) and others(14).
More robust controlled evaluative data are now needed.
We propose to study the use of TC-325 in upper and lower malignant GI bleeding compared to contemporary standard of care, and more specifically seeks funding for a pilot study to inform a subsequent peer-review application for a larger, more definitive randomized clinical trial (RCT).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- McGill University Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years or older
- able to comprehend the trial and provide written informed consent in French or English, or a close relative with power of attorney
- Patients who present with an upper or lower GI bleeding with a known luminal GI malignancy diagnosed within the past two years will be considered for enrolment. Endoscopic confirmation of an active GI bleed arising from a malignant tumor will be required for final inclusion
- Rebleeding in patients who presented with acute GIB with initial endoscopy suggesting a malignant source based on endoscopic appearance who have not been treated previously with TC-325 will also be included
Exclusion Criteria:
- Refused by patient
- Pregnancy
- Bleeding from non-malignant GI sources such as gastritis/duodenitis, Mallory Weiss syndrome, peptic ulcer disease, varices, vascular malformations, radiation proctitis, polyps, hemorrhoids, and diverticulosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control group
Current standard endoscopic therapy such as epinephrine injection, sclerotherapy, mechanical (endoclip).
contact electrocautery/thermal, and non-contact electrocalcautery (APC) ± radiation therapy, angioembolization, and/or surgery.
|
Other Names:
|
Active Comparator: TC-325
TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemostasis
Time Frame: 3 minutes after endoscopic therapy
|
The main outcome will be rate of immediate hemostasis with application of TC-325 or conventional hemostatic therapy.
Immediate hemostasis is defined as the absence of bleeding following 3 minutes of observation after endoscopic therapy.
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3 minutes after endoscopic therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rebleeding
Time Frame: 1, 3, 30, 90 and 180 days following randomization
|
Rebleeding following randomization
|
1, 3, 30, 90 and 180 days following randomization
|
Transfusion
Time Frame: 30 days after randomization
|
transfusion requirements
|
30 days after randomization
|
length of ICU admission
Time Frame: 180 days
|
need for admission to and length of stay in a monitored care unit
|
180 days
|
Length of hospitalization
Time Frame: 180 days
|
Total length of hospitalization
|
180 days
|
Complications
Time Frame: day 1
|
Complications associated with endoscopy
|
day 1
|
Additional treatment modalities
Time Frame: 30 days
|
Rates of use of additional treatment modalities to stop persistent bleeding or rebleeding after the index event
|
30 days
|
Mortality
Time Frame: 180 days
|
180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
May 8, 2014
First Submitted That Met QC Criteria
May 8, 2014
First Posted (Estimate)
May 12, 2014
Study Record Updates
Last Update Posted (Estimate)
November 22, 2016
Last Update Submitted That Met QC Criteria
November 21, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Hemorrhage
- Gastrointestinal Hemorrhage
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
Other Study ID Numbers
- 13-251-BMD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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