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IRCT20190116042380N1 IRCT 2019-03-04 Ahvaz University of Medical Sciences The effectiveness of oral Tranexamic Acid on prevention of rebleeding in patients with acute upper gastrointestinal bleeding Comparison of the effectiveness of oral Tranexamic Acid in control of gastrointestinal bleeding in patients with acute upper gastrointestinal bleeding 2019-01-06 anticipated 375 Complete https://irct.ir/trial/36854 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Balanced allocation to groups A to C in successive blocks: we will divide each letters A, B, C to a special treatment conventional. Then start from block 1, means; First patient will receive C treatment, Second patient will receive A treatment and... The first six patients were all over, we will start block 2 for the seventh patient, and in the same way to finish. BLOCK 1 1: C 2: A 3: A 4: B 5: B 6: C BLOCK 2 1: B 2: A 3: C 4: B 5: A 6: C, Blinding description: Drug and Placebo have been Prescribed for Patients in separated packets.Physician, Nurse, Patient and Data Analyser Are Unaware About Packets, But the Patients's Name and Packet Code Are Noted First of All. 3 Acute Upper Gastrointestinal Bleeding. Intervention 1: Control group: participants in this group was given four 250 mg placebo capsule (Corn Starch) daily, for 3 days. Intervention 2: Intervention group 1: participants in this group was given four 250 mg tranexamic acid (Amin Pharma co.) capsule daily, for 3 days. Intervention 3: Intervention group 2: participants in this group was given two 250 mg tranexamic acid (Amin Pharma co.) capsule and two placebo capsule (Corn Starch) daily, for 3 days. Yes - There is a plan to make this available What will be shared: information related to the main outcomes will be published. When: 6 months after ending the study To whom: Researchers in Academic Institutes Conditions: For Academic research Where to obtain: Person responsible for scientific inquiries How to obtain: By sending Email, at least 2 months Comments:
public Ali Akbar Shayesteh
Azadegan Street
Ahvaz Iran (Islamic Republic of) 61357-12794 +98 61 3292 1839 habibi.n@ajums.ac.ir Ahvaz University of Medical Sciences scientific Ali Akbar Shayesteh
Azadegan Street
Ahvaz Iran (Islamic Republic of) 61357-12794 +98 61 3292 1839 habibi.n@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients With Acute Upper Gastrointestinal Bleeding no limit no limit Both Patient's discontent Clean base Ulcers in Endoscopy Malignant Ulcers in Endoscopy Placebo Treatment - Drugs Treatment - Drugs Control group: participants in this group was given four 250 mg placebo capsule (Corn Starch) daily, for 3 days. Intervention group 1: participants in this group was given four 250 mg tranexamic acid (Amin Pharma co.) capsule daily, for 3 days. Intervention group 2: participants in this group was given two 250 mg tranexamic acid (Amin Pharma co.) capsule and two placebo capsule (Corn Starch) daily, for 3 days. Gastrointestinal Bleeding. Timepoint: one, Two and Three Days After Drug Consumption. Method of measurement: Hemoglubin Drop, Gastrointestinal Rebleeding. Hemoglobin Drop. Timepoint: Gastrointestinal Rebleeding. Method of measurement: Serial Hemoglobin measurement. Ahvaz University of Medical Sciences Approved 2019-01-05 Jundi Shapoor Medical Sciences Ethics Committee Azadegan Street Ahvaz Khouzestan Iran (Islamic Republic of)