Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

TC-325 (HEMOSPRAY™) VS. CURRENT STANDARD OF CARE IN MANAGING MALIGNANT GASTROINTESTINAL BLEEDING: A PILOT STUDY TO INFORM A RANDOMIZED CONTROLLED TRIAL.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02135627
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : November 22, 2016
Sponsor:
Collaborator:
ASGE
Information provided by (Responsible Party):
Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE May 8, 2014
First Posted Date  ICMJE May 12, 2014
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TC-325 (HEMOSPRAY™) VS. CURRENT STANDARD OF CARE IN MANAGING MALIGNANT GASTROINTESTINAL BLEEDING: A PILOT STUDY TO INFORM A RANDOMIZED CONTROLLED TRIAL.
Official Title  ICMJE Not Provided
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE MALIGNANT GASTROINTESTINAL BLEEDING
Intervention  ICMJE
  • Drug: TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.
  • Other: Current standard therapy
    Other Names:
    • epinephrine injection,
    • sclerotherapy,
    • mechanical (endoclip).
    • contact electrocautery/thermal
    • non-contact electrocalcautery (APC) ± radiation therapy,
    • angioembolization,
    • surgery
Study Arms  ICMJE
  • 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.
    Intervention: Other: Current standard therapy
  • Active Comparator: TC-325
    TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.
    Intervention: Drug: TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.
Publications * Chen YI, Wyse J, Lu Y, Martel M, Barkun AN. TC-325 hemostatic powder versus current standard of care in managing malignant GI bleeding: a pilot randomized clinical trial. Gastrointest Endosc. 2020 Feb;91(2):321-328.e1. doi: 10.1016/j.gie.2019.08.005. Epub 2019 Aug 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135627
Other Study ID Numbers  ICMJE 13-251-BMD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE ASGE
Investigators  ICMJE Not Provided
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP