TC-325 (HEMOSPRAY™) VS. CURRENT STANDARD OF CARE IN MANAGING MALIGNANT GASTROINTESTINAL BLEEDING: A PILOT STUDY TO INFORM A RANDOMIZED CONTROLLED TRIAL.
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|ClinicalTrials.gov Identifier: NCT02135627|
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : November 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|MALIGNANT GASTROINTESTINAL BLEEDING||Drug: TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery. Other: Current standard therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
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: Current standard therapy
Active Comparator: TC-325
TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.
Drug: TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.
- 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.
- Rebleeding [ Time Frame: 1, 3, 30, 90 and 180 days following randomization ]Rebleeding following randomization
- Transfusion [ Time Frame: 30 days after randomization ]transfusion requirements
- length of ICU admission [ Time Frame: 180 days ]need for admission to and length of stay in a monitored care unit
- Length of hospitalization [ Time Frame: 180 days ]Total length of hospitalization
- Complications [ Time Frame: day 1 ]Complications associated with endoscopy
- Additional treatment modalities [ Time Frame: 30 days ]Rates of use of additional treatment modalities to stop persistent bleeding or rebleeding after the index event
- Mortality [ Time Frame: 180 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135627
|McGill University Health Center|
|Montreal, Quebec, Canada, H3G 1A4|