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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid injection | Experimental | Group with tranexamic acid injection |
|
| Placebo | Placebo Comparator | Group with Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid injection | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Re-bleeding | The number of participants experiencing re-bleeding in each arm was measured within 28 days after randomisation | 28 days after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality | Total number patients who die | 30 days after randomisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ari F Syam, Dr, MD | Gastroenterology Division, Internal Medicine Department RSCM/UI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo National Central General Hospital | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25414987 | Background | 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. |
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Excluded because clinically had CKD
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid Injection | Group with tranexamic acid injection 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. |
| FG001 | Placebo | Group with Placebo Placebo: Administering placebo or sodium chloride 0,9% intravenously |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamix Acid Group | Patients received intravenous TXA (bolus 1 gram in 100 mL normal saline for 10 minutes followed by 3 grams infusion in 500 mL of normal saline for 24 hours) for a total of 24 hours. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Re-bleeding | The number of participants experiencing re-bleeding in each arm was measured within 28 days after randomisation | Posted | Count of Participants | Participants | 28 days after randomisation |
|
Adverse event collected during injection until 30 days after injection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tranexamix Acid Group | Patients received intravenous TXA (bolus 1 gram in 100 mL normal saline for 10 minutes followed by 3 grams infusion in 500 mL of normal saline for 24 hours) for a total of 24 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolism | Blood and lymphatic system disorders | Non-systematic Assessment | Venous or arterial thromboembolism |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ari Fahrial Syam | Division of Gastroenterology, Department of Internal Medicine Faculty of Medicine Universitas Indonesia -- Dr. Cipto Mangunkusumo National Center General Hospital | +62213153957 | 6704 | ari_syam@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2018 | May 16, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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All patients will receive standard treatment equally
|
| Placebo | Other | Administering placebo or sodium chloride 0,9% intravenously |
|
Patients received the same volume of placebo infusions for a total of 24 hours.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Bleeding onset <24 h | Count of Participants | Participants |
|
| Antiplatelet/anticoagulant | Count of Participants | Participants |
|
| Comorbidity | Comorbidities include patients with: Autoimmune disease, Diabetes, HIV, Cardiovascular disease, Pneumonia, Malignancy, Compensated cirrhosis and Decompensated cirrhosis | Count of Participants | Participants |
|
| Compensated cirrhosis | Count of Participants | Participants |
|
| Decompensated cirrhosis | Count of Participants | Participants |
|
| Glasgow-Blatchford score | The Glasgow-Blatchford Score (GBS) is a clinical risk scoring system used to assess the severity of upper gastrointestinal bleeding and predict the need for medical intervention. The total score ranges from 0 to 23, with higher scores indicating a greater risk of severe bleeding and a higher likelihood of requiring intervention. | Mean | Standard Deviation | Scores on a scale (0-23) |
|
| Haemoglobin | Mean | Standard Deviation | g/dL |
|
| Upper GI bleeding | Count of Participants | Participants |
|
| Variceal bleeding | Count of Participants | Participants |
|
| Inhospital endoscopy | Count of Participants | Participants |
|
| PRC transfusion (mL) | Mean | Standard Deviation | milliliter |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | All Cause Mortality | Total number patients who die | Posted | Count of Participants | Participants | 30 days after randomisation |
|
|
|
| 4 |
| 19 |
| 1 |
| 19 |
| 0 |
| 19 |
| EG001 | Placebo | Patients received the same volume of placebo infusions for a total of 24 hours. | 5 | 23 | 1 | 23 | 0 | 23 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |