Gastrointestinal Bleeding
Conditions
Keywords
Gastrointestinal bleeding, Tranexamic acid, Clinical trial
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.
Interventions
DRUGTranexamic 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.
OTHERPlacebo
Administering placebo or sodium chloride 0,9% intravenously
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
All patients will receive standard treatment equally
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-bleeding | 28 days after randomisation | The number of participants experiencing re-bleeding in each arm was measured within 28 days after randomisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality | 30 days after randomisation | Total number patients who die |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORAri F Syam, Dr, MD
Gastroenterology Division, Internal Medicine Department RSCM/UI
Participant flow
Recruitment details
Between July 1, 2018 and December 31, 2019, 48 patients were enrolled of whom 42 of them were eligible. The trial was done at Cipto Mangunkusumo National Hospital and Budhi Asih Regional Hospital in DKI Jakarta, Indonesia.
Pre-assignment details
Excluded because clinically had CKD
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 13.87 |
| Antiplatelet/anticoagulant | 1 Participants |
| Bleeding onset <24 h | 12 Participants |
| Comorbidity | 17 Participants |
| Compensated cirrhosis | 7 Participants |
| Decompensated cirrhosis | 9 Participants |
| Glasgow-Blatchford score | 9.9 Scores on a scale (0-23) STANDARD_DEVIATION 2.95 |
| Haemoglobin | 8.52 g/dL STANDARD_DEVIATION 3.511 |
| Inhospital endoscopy | 21 Participants |
| PRC transfusion (mL) | 906.5 milliliter STANDARD_DEVIATION 956.24 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Indonesia | 23 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 21 Participants |
| Upper GI bleeding | 23 Participants |
| Variceal bleeding | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 19 | 5 / 23 |
| other Total, other adverse events | 0 / 19 | 0 / 23 |
| serious Total, serious adverse events | 1 / 19 | 1 / 23 |
Outcome results
None listed