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

NCT02534571 | Completed Phase 3

• 1 other identifier: TC325 Study
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• number of participants who presents and confirmed endoscopically as recurrent upper gastro-intestinal bleeding

  ( 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.

  30 days

Secondary Outcomes (10)

• number of participants who required subsequent endoscopic treatment upon recurrent bleeding

  30 days

• number of participants who required subsequent surgical treatment upon recurrent bleeding

  30 days

• number of participants who required further blood transfusion post randomization

  30 days

• Days of hospitalization post randomization

  60 days

• number of days which participant required caring in Intensive care unit post randomization

  60 days

Study Arms (2)

TC-325

EXPERIMENTAL

Endoscopic Application of a Hemostatic Powder TC-325, \<=150gm , once

Device: Endoscopic Application of a Hemostatic Powder TC-325

standard treatment

ACTIVE COMPARATOR

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; Drug: Epinephrine; Device: thermo-coagulation

Interventions

Endoscopic Application of a Hemostatic Powder TC-325 DEVICE

Endoscopic Application of a Hemostatic Powder TC-325 \<=150g once

TC-325

Hemo-clipping DEVICE

Hemo-clipping \<=20 clips

Also known as: quick clips

standard treatment

Epinephrine DRUG

epinephrine injection endoscopically \<20 mls

Also known as: adrenaline

standard treatment

thermo-coagulation DEVICE

contact thermo-coagulation \< = 4 pulses

Also known as: contact thermo-coagulation

standard treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• North District Hospital: collaborator
• King Chulalongkorn Memorial Hospital: collaborator
• Changi General Hospital: collaborator

Study Sites (1)

Endoscopy Centre

Hong Kong, HONG KONG, China

Location

Related Publications (2)

• Lau JYW, Pittayanon R, Kwek A, Tang RS, Chan H, Rerknimitr R, Lee J, Ang TL, Suen BY, Yu YY, Chan FKL, Sung JJY. Comparison of a Hemostatic Powder and Standard Treatment in the Control of Active Bleeding From Upper Nonvariceal Lesions : A Multicenter, Noninferiority, Randomized Trial. Ann Intern Med. 2022 Feb;175(2):171-178. doi: 10.7326/M21-0975. Epub 2021 Dec 7.

  PMID: 34871051 DERIVED

• Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. Am J Gastroenterol. 2021 May 1;116(5):899-917. doi: 10.14309/ajg.0000000000001245.

  PMID: 33929377 DERIVED

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• JAMES YW LAU, MD

  CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 27, 2015
• Study Start: September 7, 2015
• Primary Completion: January 14, 2019
• Study Completion: April 30, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)