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To Compare a Hemostatic Powder TC-325 and Standard Treatment in the Control of Acute Upper Gastrointestinal Bleeding From Nonvariceal Causes (TC325)

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ClinicalTrials.gov Identifier: NCT02534571
Recruitment Status : Recruiting
First Posted : August 27, 2015
Last Update Posted : October 23, 2018
Sponsor:
Collaborators:
North District Hospital
King Chulalongkorn Memorial Hospital
Changi General Hospital
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong

Brief Summary:
Acute upper gastrointestinal bleeding is a common medical emergency. Bleeding peptic ulcers and other non-variceal causes constitute to about 95% of all cases of bleeding. Endoscopic treatment stops active bleeding, reduces rate of further bleeding and leads to improved patients outcomes. Endoscopic treatment can be technically demanding especially with lesions in difficult anatomic positions and to endoscopists with less experience. TC-325 is a propriety mineral blend hemostatic powder used to compress external civilian and military traumatic injuries. Investigators reported the first endoscopic application of TC-325 in 20 patients with actively bleeding gastro-duodenal ulcers. Investigators were able to stop bleeding in 19 of them. Subsequent case series from others reported a similar rate in the acute control of bleeding. To further define the role of TC-325 as a mono-therapy, a comparison to the current standard in endoscopic treatment is required. A non-inferiority randomized trial is being proposed to compare endoscopic use of TC-325 as a mono-therapy to current standards (i.e. hemoclips or thermo-coagulation with or without pre-injection with diluted epinephrine) in hemostatic treatment in patients with acute upper gastrointestinal bleeding from non-variceal causes. The non-inferiority primary endpoint is control of bleeding over 30 days from randomization. Other outcome endpoints include further endoscopic, angiographic or surgical treatments, hospitalization, blood transfusion and mortality. Investigators also compare ease of therapy measured by procedure time and a 10 cm visual analogue scale rated by endoscopists. Endoscopic application of TC-325 is a simple and less skill dependent technique. It may prove useful in bleeding from anatomically challenging sites of the gastro-duodenal tract.

Condition or disease Intervention/treatment Phase
Acute Upper Gastrointestinal Bleeding Device: Endoscopic Application of a Hemostatic Powder TC-325 Device: Hemo-clipping Drug: Epinephrine Device: thermo-coagulation Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Application of a Hemostatic Powder TC-325 Versus Standard Treatment in the Control of Acute Upper Gastrointestinal Bleeding From Nonvariceal Causes; A Non-inferiority Randomized Trial
Actual Study Start Date : September 7, 2015
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Epinephrine

Arm Intervention/treatment
Experimental: TC-325
Endoscopic Application of a Hemostatic Powder TC-325, <=150gm , once
Device: Endoscopic Application of a Hemostatic Powder TC-325
Endoscopic Application of a Hemostatic Powder TC-325 <=150g once

Active Comparator: standard treatment
standard treatment of either hemo-clipping or thermo-coagulation with or without pre injection with diluted epinephrine <=20 clip or4 pulse , once only
Device: Hemo-clipping
Hemo-clipping <=20 clips
Other Name: quick clips

Drug: Epinephrine
epinephrine injection endoscopically <20 mls
Other Name: adrenaline

Device: thermo-coagulation
contact thermo-coagulation < = 4 pulses
Other Name: contact thermo-coagulation




Primary Outcome Measures :
  1. number of participants who presents and confirmed endoscopically as recurrent upper gastro-intestinal bleeding [ Time Frame: 30 days ]
    ( Further bleeding is defined by failure to control bleeding at index endoscopy, renewed hematemesis, fresh melena with circulatory instability after initial control of bleeding (systolic blood pressure of 90 mmHg or less or pulse rate of 110 per minute or more) and/or a drop in haemoglobin by 2 g/dl and haematocrit by 10% over 24 hours despite adequate transfusion. Further bleeding after initial endoscopic hemostasis requires documentation with immediate endoscopy which finds fresh blood and active bleeding from a previously treated upper GIB source. Patients with further bleeding after initial endoscopic control are considered to have reached an outcome endpoint.


Secondary Outcome Measures :
  1. number of participants who required subsequent endoscopic treatment upon recurrent bleeding [ Time Frame: 30 days ]
    number of participants who required subsequent endoscopic treatment upon recurrent bleeding

  2. number of participants who required subsequent surgical treatment upon recurrent bleeding [ Time Frame: 30 days ]
    number of participants who required subsequent surgical treatment upon recurrent bleeding

  3. number of participants who required further blood transfusion post randomization [ Time Frame: 30 days ]
    number of participants who required further blood transfusion post randomization

  4. Days of hospitalization post randomization [ Time Frame: 60 days ]
    Days of hospitalization post randomization

  5. number of days which participant required caring in Intensive care unit post randomization [ Time Frame: 60 days ]
    number of days which participant required caring in Intensive care unit post randomization

  6. number of participants with adverse events as a Measure of Safety and Tolerability (related or unrelated to endoscopic treatment) [ Time Frame: 30 days ]
    number of participants with adverse events as a Measure of Safety and Tolerability (related or unrelated to endoscopic treatment

  7. number of participants with mortality from all causes within 30 days randomization. [ Time Frame: 30 days ]
    number of participants with mortality from all causes within 30 days randomization

  8. Ease of endoscopic treatment as measured by Visual Analog Scale reported by Endoscopist [ Time Frame: 3 days ]
    self reported VAS scale: 0 cm to 10 cm

  9. procedure time of endoscopic treatment [ Time Frame: 3 days ]
    procedure time of endoscopic treatment

  10. number of participant who need extra assistant to accomplish the endoscopic treatment [ Time Frame: 3 days ]
    number of participant who need extra assistant eg advanced endoscopist to accomplish the endoscopic treatment other than the main endoscopist



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with overt signs of upper gastrointestinal bleeding (hematemesis, melena and/or circulatory instability)
  • documented bleeding (Forrest I) from a non-variceal upper gastrointestinal source (gastro-duodenal ulcers, Mallory Weiss tear, cancers, Dieulafoy's and other vascular lesions) at endoscopy.

Exclusion Criteria:

  • without a full informed consent from the patient or his next of kin
  • Age <18 years
  • Pregnant
  • Lactating women

Information from the National Library of Medicine

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): NCT02534571


Contacts
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Contact: JAMES YW LAU, MD 35051411 laujyw@surgery.cuhk.edu.hk
Contact: Bing-yee SUEN, BHSc 35052640 suenbingyee@surgery.cuhk.edu.hk

Locations
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China, Hong Kong
Endoscopy Centre Recruiting
Hong Kong, Hong Kong, China
Contact: James Y LAU, Prof         
Sponsors and Collaborators
Chinese University of Hong Kong
North District Hospital
King Chulalongkorn Memorial Hospital
Changi General Hospital
Investigators
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Principal Investigator: JAMES YW LAU, MD CUHK

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Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02534571     History of Changes
Other Study ID Numbers: TC325 Study
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Epinephrine
Racepinephrine
Hemostatics
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Coagulants