Tranexamic Acid for Upper Gastrointestinal Bleeding - Full Text View

Purpose

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

Condition	Intervention	Phase
Acute Upper Gastrointestinal Hemorrhage	Drug: Early intravenous tranexamic acid administration Drug: placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Early Administration of Intravenous Tranexamic Acid for Upper Gastrointestinal Bleeding Prior to Endoscopy

Resource links provided by NLM:

MedlinePlus related topics: Bleeding Endoscopy Gastrointestinal Bleeding

Drug Information available for: Tranexamic acid

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Proportion of patients requiring early endoscopic treatment [ Time Frame: Within 24 hours of emergency department visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Endoscopic signs of bleeding [ Time Frame: Within 24 hours of emergency department visit ] [ Designated as safety issue: No ]
Length of stay [ Time Frame: Within one-month of emergency department visit ] [ Designated as safety issue: Yes ]
Need for urgent endoscopy [ Time Frame: Within 24 hours of emergency department visit ] [ Designated as safety issue: No ]
Endoscopic procedure time/difficulty [ Time Frame: Within 24 hours of emergency department visit ] [ Designated as safety issue: No ]
Need for transfusion [ Time Frame: Within one-month of emergency department visit ] [ Designated as safety issue: Yes ]
Need for surgery/angiographic intervention [ Time Frame: Within one-month of emergency department visit ] [ Designated as safety issue: Yes ]
rate of recurrent bleeding [ Time Frame: Within one-month of emergency department visit ] [ Designated as safety issue: Yes ]
death of any cause [ Time Frame: Within one-month of emergency department visit ] [ Designated as safety issue: Yes ]
thromboembolic complications [ Time Frame: Within one-month of emergency department visit ] [ Designated as safety issue: Yes ]

Other Outcome Measures:

Effect modification by hyperfibrinolysis and other coagulation related factors [ Time Frame: Variable (within 24-hour and 1-month of emergency department visit) ] [ Designated as safety issue: No ]
Separate analysis looking into the interaction between coagulation function and tranexamic acid effect


Estimated Enrollment:	414
Study Start Date:	October 2012
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Early intravenous tranexamic acid administration 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 Initial history taking and physical examination --> enrollment --> 1g bolus over 10 minutes followed slow infusion over 8 hours. Other Names: tranexamic acid administration transamine administration antifibrinolytics administration
Placebo Comparator: Placebo group Normal saline (placebo) administration instead of tranexamic acid solution	Drug: placebo

Detailed Description:

Previous studies reported that IV/Oral administration of tranexamic acid improves the outcome upper gastrointestinal bleeding. However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm. Although a recent meta-analysis done by Cochrane review group concluded that it improves patient survival, other review articles including "Gut" suggested that a well-designed clinical study is needed for re-evaluation of the efficacy and safety of the drug in current clinical situation. We hypothesized that early administration of the drug will significantly decrease the proportion of patient requiring early endoscopic treatment.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)
  - Any malignancy except those cured and has not recurred more than two years
- Patients with history or presence of subarachnoid hemorrhage
- Acquired color vision impairment, visual loss and retinal venous and arterial occlusions
- Past history of seizure or organic brain lesion that predispose to seizure disorder
Previous history of variceal bleeding
Cases where informed consent is unobtainable

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713101

Contacts


Contact: Kyuseok Kim, MD	+82-31-787-7572	dremkks@snubh.org
Contact: Joonghee Kim, MD	+82-10-9489-3696	joonghee@me.com

Locations


Korea, Republic of
Seoul National University Bundang Hospital	Recruiting
Seongnam-si, Kyeongi-do, Korea, Republic of
Contact: Kyuseok Kim, MD +82-31-787-7572 dremkks@snubh.org
Contact: Joonghee Kim, MD +82-10-9489-3696 joonghee@me.com

Sponsors and Collaborators

Seoul National University Hospital

Investigators


Study Director:	Kyuseok Kim, MD	Professor, department of emergency medicine
Principal Investigator:	Sang Hyub Lee, MD	Professor, department of internal medicine (gastroenterology)
Principal Investigator:	Cheol Min Shin, MD	Professor, department of internal medicine (gastroenterology)

More Information

No publications provided


Responsible Party:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT01713101 History of Changes
Other Study ID Numbers:	B-1207-163-002
Study First Received:	October 18, 2012
Last Updated:	May 14, 2014
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:


Gastrointestinal Hemorrhage Peptic Ulcer Hemorrhage Hematemesis Melena Tranexamic acid

Additional relevant MeSH terms:


Gastrointestinal Hemorrhage Digestive System Diseases Gastrointestinal Diseases Hemorrhage Pathologic Processes Tranexamic Acid Antifibrinolytic Agents	Coagulants Fibrin Modulating Agents Hematologic Agents Hemostatics Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

Tranexamic Acid for Upper Gastrointestinal Bleeding (TAUGIB)