Clinical trial NCT03540368: Tranexamic Acid for The Treatment of Gastrointestinal Bleeding
Official title: The Role of Tranexamic Acid for the Treatment of Gastrointestinal Bleeding: A Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Gastrointestinal Bleeding
Keywords: Gastrointestinal bleeding
Tranexamic acid
Clinical trial
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Re-bleeding
timeFrame: 30 days after randomisation
Secondary outcomes:
measure: Number of death
timeFrame: 30 days after randomisation
measure: Need for blood transfusion
timeFrame: 30 days after randomisation
measure: Length of stay in intensive care unit
timeFrame: 30 days after randomisation
measure: Need for endoscopic hemostasis
timeFrame: 30 days after randomisation
measure: Quality of life (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health)
timeFrame: 30 days after randomisation
measure: Level of anxiety
timeFrame: 30 days after randomisation
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo National Central General Hospital
state: DKI Jakarta
Study officials:
affiliation: Gastroenterology Division, Internal Medicine Department RSCM/UI
name: Ari F Syam, Dr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.