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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03540368 |
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Date of registration:
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15/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tranexamic Acid for The Treatment of Gastrointestinal Bleeding
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Scientific title:
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The Role of Tranexamic Acid for the Treatment of Gastrointestinal Bleeding: A Randomized Double-blind Controlled Trial |
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Date of first enrolment:
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July 4, 2018 |
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Target sample size:
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336 |
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Recruitment status: |
Suspended |
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URL:
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https://clinicaltrials.gov/show/NCT03540368 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Ari F Syam, Dr, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gastroenterology Division, Internal Medicine Department RSCM/UI |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastrointestinal Bleeding
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Intervention(s)
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Other: Placebo
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Drug: Tranexamic acid injection
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Primary Outcome(s)
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Re-bleeding
[Time Frame: 30 days after randomisation]
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Secondary Outcome(s)
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Length of stay in intensive care unit
[Time Frame: 30 days after randomisation]
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Quality of life (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health)
[Time Frame: 30 days after randomisation]
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Need for endoscopic hemostasis
[Time Frame: 30 days after randomisation]
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Number of death
[Time Frame: 30 days after randomisation]
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Level of anxiety
[Time Frame: 30 days after randomisation]
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Need for blood transfusion
[Time Frame: 30 days after randomisation]
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Secondary ID(s)
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18-04-0393
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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