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Tranexamic acid efficacy in reduction of upper gastointestinal bleeding complications

Evaluation of Tranexamic acid effect on upper gastrointestinal bleeding outcomes

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014112911956N4
Enrollment
100
Registered
2014-12-19
Start date
2015-01-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper gastrointestinal haemorrhage. Haematemesis

Interventions

Intervention 1: Intervention group: after standard treatment of upper GI bleeding, these patients would receive intravenously 1 gr tranexamic acid (100 and 250 mg vials are available) in 10 minutes, t
Treatment - Drugs
Behavior
Intervention group: after standard treatment of upper GI bleeding, these patients would receive intravenously 1 gr tranexamic acid (100 and 250 mg vials are available) in 10 minutes, then 1 gr tranexa
Control group: after standard treatment of upper GI bleeding, these patients would receive normal saline as placebo, as same the intervention group, first in a vial in 10 minutes and then slow intrave

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: All patients with signs and symptoms of upper gastrointestinal bleeding, which will present to emergency ward and have all of these conditions: age more than 18 years old and hemodynamically stable condition(systolic blood pressure more than 90 mmHg and pulse rate less than 110 bpm), as well as accept to contribute in the study(by consent form). Exclusion criteria: age less than 18 years old; pregnancy and breast feeding; Tranexamic Acid contraindications: history of thromboembolic disorders, nephrotic syndrome, current estrogen consumption, history of allergy to tranexamic acid or variceal hemorrhage; patients that need to anticoagulant therapy; probable DIC; history of epilepsy or brain disorders; cancer ( except for who has been treated and no recurrence has occurred in one years ago).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Decrease in mortality of upper gastrointestinal bleeding. Timepoint: one week. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
Decrease in rebleeding. Timepoint: 24 houres. Method of measurement: Questionnaire.;Decrease in need to endoscopic treatment. Timepoint: 24 houres. Method of measurement: Questionnaire.;Decrease in need to blood component transfusion. Timepoint: first week. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSanaz Javdani Masroor Tanha

Mashhad University of Medical Sciences

javedanis921@mums.ac.ir+98 51 3854 3031

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026