Tranexamic Acid for The Treatment of Gastrointestinal Bleeding

Gastrointestinal Bleeding Clinical Trial

Official title:

The Role of Tranexamic Acid for the Treatment of Gastrointestinal Bleeding: A Randomized Double-blind Controlled Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03540368
• Other study ID #: 18-04-0393
• Status: Suspended
• Phase: N/A
• Start date: July 4, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: August 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a randomized double-blind controlled trial study. Interventions were given in the form of tranexamic acid injection compared to placebo in patients with acute upper and lower gastrointestinal bleeding. Tranexamic acid were administered intravenously 1 gram loading dose, followed by 3 grams maintenance dose in infusion for 24 hours. Other routine and standardized drugs for gastrointestinal bleeding will still be given. Statistical analysis will use: Chi square test or Kolmogorov-Smirnov with alternative Fisher test for categorical dependent-variable; Independent T-Test with alternative Mann-Whitney test for two-group numerical dependent-variable; and one-way ANOVA with alternative Kruskal-Wallis for more than two-groups numerical dependent-variable.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 336
• Est. completion date: September 1, 2020
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults

• Patients with acute lower and upper gastrointestinal bleeding (assessed clinically)

• Patients agreed to participate in the study and signed the informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Drug:
• Tranexamic acid injection
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.

Other:
• Placebo
Administering placebo or sodium chloride 0,9% intravenously

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Central General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-bleeding	Total incidence number of re-bleeding	30 days after randomisation
Secondary	Number of death	Total number patients who die	30 days after randomisation
Secondary	Need for blood transfusion	Total number of patients with blood transfusion	30 days after randomisation
Secondary	Length of stay in intensive care unit	Average time of stay each participants in intensive care unit	30 days after randomisation
Secondary	Need for endoscopic hemostasis	Total number of patients with endoscopic hemostasis	30 days after randomisation
Secondary	Quality of life (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health)	Short Form-36 Questionnaire includes one scale for each of eight measured health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. All health domain scales are scored using norm-based scores ranging 0 to 100 with higher scores indicate better health	30 days after randomisation
Secondary	Level of anxiety	Hamilton Anxiety Rating Scale; Each item is scored of 0 (not present) to 4 (severe), with total score range of 0-56, where <14 indicates no anxiety, 14-20 mild anxiety, 21-27 moderate anxiety, 28-41 severe anxiety and 42-56 very severe anxiety	30 days after randomisation