NCT03540368

Brief Summary

Studies showed that in cases of gastrointestinal bleeding, injection tranexamic acid decreasing the risk of death and the need of surgical intervention. However, the quality of most clinical trials were not good and the results were not significant. Injection tranexamic acid does not become one of the treatment option in the international guidelines nor in national consensus, so the effectiveness and the safety of its use in the treatment of gastrointestinal bleeding remains unclear and not routinely used. In Indonesia, injection tranexamic acid in gastrointestinal bleeding is limitedly used and recorded. Therefore, a clinical trial study of injection tranexamic acid is required to assess the effectiveness and the safety in the treatment of gastrointestinal bleeding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

May 15, 2018

Results QC Date

September 1, 2020

Last Update Submit

March 8, 2026

Conditions

Gastrointestinal Bleeding

Keywords

Gastrointestinal bleedingTranexamic acidClinical trial

Outcome Measures

Primary Outcomes (1)

  • Re-bleeding

    The number of participants experiencing re-bleeding in each arm was measured within 28 days after randomisation

    28 days after randomisation

Secondary Outcomes (1)

  • All Cause Mortality

    30 days after randomisation

Study Arms (2)

Tranexamic acid injection

EXPERIMENTAL

Group with tranexamic acid injection

Drug: Tranexamic acid injection

Placebo

PLACEBO COMPARATOR

Group with Placebo

Other: Placebo

Interventions

Tranexamic acid injectionDRUG

Administering tranexamic acid loading dose 1 gram in 100 cc sodium chloride 0,9%, followed by maintenance dose 3 grams in infusion for 24 hours.

Also known as: TXA
Tranexamic acid injection
PlaceboOTHER

Administering placebo or sodium chloride 0,9% intravenously

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults
  • Patients with acute lower and upper gastrointestinal bleeding (assessed clinically)
  • Patients agreed to participate in the study and signed the informed consent

You may not qualify if:

  • Allergy with tranexamic acid
  • Patients considered by the clinician can not be randomized to participate in the study
  • Patients with chronic kidney disease stage III - V

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo National Central General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (1)

  • Bennett C, Klingenberg SL, Langholz E, Gluud LL. Tranexamic acid for upper gastrointestinal bleeding. Cochrane Database Syst Rev. 2014 Nov 21;2014(11):CD006640. doi: 10.1002/14651858.CD006640.pub3.

    PMID: 25414987BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Limitations and Caveats

High mortality in this trial (21%) compared to references (8%--10%) caused the interim analysis was carried out earlier. Limitations of our study include insufficient power to detect assumed differences in clinical outcomes.

Results Point of Contact

Title
Ari Fahrial Syam
Organization
Division of Gastroenterology, Department of Internal Medicine Faculty of Medicine Universitas Indonesia -- Dr. Cipto Mangunkusumo National Center General Hospital
ari_syam@hotmail.com
+62213153957

Study Officials

  • Ari F Syam, Dr, MD

    Gastroenterology Division, Internal Medicine Department RSCM/UI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
All patients will receive standard treatment equally
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Gastroenterology Hepatology Consultant

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 30, 2018

Study Start

July 1, 2018

Primary Completion

March 1, 2019

Study Completion

December 31, 2019

Last Updated

March 27, 2026

Results First Posted

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)