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

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

Interventions

DEVICE

Endoscopic Application of a Hemostatic Powder TC-325

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

DEVICE

Hemo-clipping

Hemo-clipping \<=20 clips

DRUG

Epinephrine

epinephrine injection endoscopically \<20 mls

DEVICE

thermo-coagulation

contact thermo-coagulation \< = 4 pulses

Sponsors & Collaborators

• North District Hospital

  collaborator OTHER

• King Chulalongkorn Memorial Hospital

  collaborator OTHER

• Changi General Hospital

  collaborator OTHER

• Chinese University of Hong Kong

  lead OTHER

Principal Investigators

• JAMES YW LAU, MD · CUHK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-07

Primary Completion

2019-01-14

Completion

2019-04-30

Countries

• China

Study Locations