Tranexamic Acid for Upper Gastrointestinal Bleeding

NCT01713101 | Unknown Phase 3

• 1 other identifier: B-1207-163-002
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to see whether the early intravenous administration of tranexamic acid improves the outcome of acute upper gastrointestinal bleeding.

Conditions

Acute Upper Gastrointestinal Hemorrhage

Keywords

Gastrointestinal Hemorrhage; Peptic Ulcer Hemorrhage; Hematemesis; Melena; Tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Proportion of patients requiring early endoscopic treatment

  Within 24 hours of emergency department visit

Secondary Outcomes (9)

• Endoscopic signs of bleeding

  Within 24 hours of emergency department visit

• Length of stay

  Within one-month of emergency department visit

• Need for urgent endoscopy

  Within 24 hours of emergency department visit

• Endoscopic procedure time/difficulty

  Within 24 hours of emergency department visit

• Need for transfusion

  Within one-month of emergency department visit

Other Outcomes (1)

• Effect modification by hyperfibrinolysis and other coagulation related factors

  Variable (within 24-hour and 1-month of emergency department visit)

Study Arms (2)

Early intravenous tranexamic acid administration

EXPERIMENTAL

Early intraveous administration of tranexamic acid (1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours

Drug: Early intravenous tranexamic acid administration

Placebo group

PLACEBO COMPARATOR

Normal saline (placebo) administration instead of tranexamic acid solution

Drug: placebo

Interventions

Early intravenous tranexamic acid administration DRUG

Initial history taking and physical examination --\> enrollment --\> 1g bolus over 10 minutes followed slow infusion over 8 hours.

Also known as: tranexamic acid administration, transamine administration, antifibrinolytics administration

Early intravenous tranexamic acid administration

placebo DRUG

Placebo group

Eligibility Criteria

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

You may qualify if:

• Chief complaint of hematemesis, melena or hematochezia
• and objective signs of upper gastrointestinal bleeding

You may not qualify if:

• Pregnant woman, age less than 18
• Patients whose use of the study drug is contraindicated
• Increased thromboembolic risk
• History of thromboembolic disease
• Alleged inherited thrombophilic disorders
• Malignancy (except those cured and has not recurred more than two years)
• Nephrotic syndrome
• Estrogen use
• Pregnancy
• HIT, APA
• High-risk for cardioembolism
• Underlying structural heart disease where anticoagulation is indicated
• Underlying cardiac rhythm disorder where anticoagulation is indicated (e.g. atrial fibrillation/flutter)
• Possibilities of ongoing DIC
• Signs and symptoms suggestive of clinically significant infectious disease (e.g. body temperature \> 38 degree)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Kyeongi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Peptic Ulcer Hemorrhage; Hematemesis; Melena

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Kyuseok Kim, MD

  Professor, department of emergency medicine

  STUDY DIRECTOR

• Sang Hyub Lee, MD

  Professor, department of internal medicine (gastroenterology)

  PRINCIPAL INVESTIGATOR

• Cheol Min Shin, MD

  Professor, department of internal medicine (gastroenterology)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyuseok Kim, MD

CONTACT

+82-31-787-7572; dremkks@snubh.org

Joonghee Kim, MD

CONTACT

+82-10-9489-3696; joonghee@me.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 24, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 16, 2014

Record last verified: 2014-05

Locations

KR (1)