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Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage

Primary Purpose

Gastrointestinal Hemorrhage, Tranexamic Acid, Emergency Department

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Tranexamic acid 5%
Placebo
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients presenting with upper gastrointestinal hemorrhage to the ED
  • Patients older than 18 years
  • Patients who agree to participate the study by reading and signing the informed consent form

Exclusion Criteria:

  • Patients younger than 18 years
  • Patients who do not agree to participate the study
  • Documented or declared allergy to tranexamic acid
  • Upper gastrointestinal hemorrhage secondary to trauma
  • Upper gastrointestinal hemorrhage secondary to esophageal varices
  • Patients who cannot undergo to endoscopy for any reason
  • History for thromboembolic disease
  • Patients with renal impairment

Sites / Locations

  • Kocaeli University, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid 5%

Placebo

Arm Description

Tranexamic acid 5%, 2000 mg (40 mL) in 60 mL normal saline (0.9%) solution (total 100 mL)

0.9% normal saline solution (total 100 mL)

Outcomes

Primary Outcome Measures

Mortality
In- or out of hospital mortality
Re-bleeding
Recurrent upper gastrointestinal hemorrhage
Endoscopic intervention need
Surgical intervention need
ED revisit

Secondary Outcome Measures

Length of stay in the hospital
Administered blood products in the ED
Adverse reactions
Thromboembolic events, anaphylaxis

Full Information

First Posted
September 12, 2016
Last Updated
March 5, 2018
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT02903017
Brief Title
Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage
Official Title
Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage: A Double-Blind, Randomized, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments. Although new drugs and endoscopic techniques were easily applied in various settings in this condition, the role of local administered therapies such as antifibrinolytic agents remain unclear. The investigators aimed to compare standard therapy (proton pump inhibitors, endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in upper gastrointestinal hemorrhage in a double-blind, randomized trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage, Tranexamic Acid, Emergency Department, Antifibrinolytic Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid 5%
Arm Type
Active Comparator
Arm Description
Tranexamic acid 5%, 2000 mg (40 mL) in 60 mL normal saline (0.9%) solution (total 100 mL)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% normal saline solution (total 100 mL)
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid 5%
Intervention Description
Via nasogastric tube, 100 mL
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Via nasogastric tube, 100 mL
Primary Outcome Measure Information:
Title
Mortality
Description
In- or out of hospital mortality
Time Frame
One month
Title
Re-bleeding
Description
Recurrent upper gastrointestinal hemorrhage
Time Frame
One month
Title
Endoscopic intervention need
Time Frame
One month
Title
Surgical intervention need
Time Frame
One month
Title
ED revisit
Time Frame
One month
Secondary Outcome Measure Information:
Title
Length of stay in the hospital
Time Frame
One month
Title
Administered blood products in the ED
Time Frame
One month
Title
Adverse reactions
Description
Thromboembolic events, anaphylaxis
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presenting with upper gastrointestinal hemorrhage to the ED Patients older than 18 years Patients who agree to participate the study by reading and signing the informed consent form Exclusion Criteria: Patients younger than 18 years Patients who do not agree to participate the study Documented or declared allergy to tranexamic acid Upper gastrointestinal hemorrhage secondary to trauma Upper gastrointestinal hemorrhage secondary to esophageal varices Patients who cannot undergo to endoscopy for any reason History for thromboembolic disease Patients with renal impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurettin Özgür Doğan, M.D., Assoc. Prof.
Organizational Affiliation
Kocaeli University, Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University, Faculty of Medicine
City
Kocaeli
ZIP/Postal Code
41050
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
11511559
Citation
Hawkey GM, Cole AT, McIntyre AS, Long RG, Hawkey CJ. Drug treatments in upper gastrointestinal bleeding: value of endoscopic findings as surrogate end points. Gut. 2001 Sep;49(3):372-9. doi: 10.1136/gut.49.3.372.
Results Reference
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PubMed Identifier
7018048
Citation
Bergqvist D, Dahlgren S, Hessman Y. Local inhibition of the fibrinolytic system in patients with massive upper gastrointestinal hemorrhage. Ups J Med Sci. 1980;85(2):173-8. doi: 10.3109/03009738009179185.
Results Reference
background
PubMed Identifier
4122561
Citation
Cormack F, Chakrabarti RR, Jouhar AJ, Fearnley GR. Tranexamic acid in upper gastrointestinal haemorrhage. Lancet. 1973 Jun 2;1(7814):1207-8. doi: 10.1016/s0140-6736(73)90525-4. No abstract available.
Results Reference
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Learn more about this trial

Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage

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