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Early Administration of Intravenous Tranexamic Acid in Acute Gastrointestinal Bleeding Prior to Endoscopy

Comparison of Systemic and Topical plus systemic Tranexamic acid versus placebo in urgent endosopy rate for acute gastrointestinal bleeding:

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014120120178N1
Enrollment
516
Registered
2015-01-20
Start date
2014-11-10
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

Acute Gastrointestinal hemorrhage. Gastrointestinal haemorrhage, unspecified

Interventions

Intervention 1: Group A :tranexamic acid 1 g slow and diluted IV injection q6h for 24hours.Group B:tranexamic acid 1 g slow and diluted IV injection q6h for 24hours plus topical -single dose tranexam
Treatment - Drugs
Group A :tranexamic acid 1 g slow and diluted IV injection q6h for 24hours.Group B:tranexamic acid 1 g slow and diluted IV injection q6h for 24hours plus topical -single dose tranexamic acid 1 g in
Group B:tranexamic acid 1 g slow and diluted IV injection q6h for 24hours plus topical -single dose tranexamic acid 1 g in 500 normal sailin by NG rout with NG clamp for 30 minute and then NG set free
Group C:normal sailin as the placebo same as the two mentioned above rout

Sponsors

Colorectal Research Center,Rasoul Akram Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria:Chief complaint of hematemesis, melena or hematochezia and objective signs of gastrointestinal bleeding,and age more than 18 Exclusion Criteria:Pregnancy , lactation,Oral Contraceotive Pill users,History of thromboembolic disease(cardiac and/or cerebrovascular thrombotic events,pulmonary thromboembolc eventi,deep vein thrombosis),Malignancy (except those cured and has not recurred more than two years), End stage renal disease and /or Nephrotic syndrome, Underlying cardiac rhythm disorder where anticoagulation is indicated (e.g. atrial fibrillation/flutter),Signs and symptoms suggestive of clinically significant infectious disease (e.g. body temperature > 38 degree),Acquired color vision impairment, visual loss and retinal venous and arterial occlusions,Past history of seizure ,severe liver disease and/or previous history of variceal bleeding,Cases where informed consent is unobtainable, any allergic history to this medication

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Urgent endosopy rate. Timepoint: ;first endoscopy at less than 24hour after emergency visit. Method of measurement: Time frame as hour.

Secondary

MeasureTime frame
Endoscopic detection rate in early endoscopy. Timepoint: First 24 hours. Method of measurement: Report of early endoscopy.;Blood transfusion rate. Timepoint: First 24 and 72 hours and first 1 months after bleeding. Method of measurement: Number of Pack Cell.;Endoscopic intervention rate in early endoscopy. Timepoint: Early endoscopy in first 24 hours. Method of measurement: Report of early endoscopy.;Rebleeding rate. Timepoint: First 24 and 72 hours and first 1 months after bleeding. Method of measurement: Data gathering sheet.;Surgical intervention rate. Timepoint: First 24 and 72 hours and first 1 months after bleeding. Method of measurement: Data gathering sheet.;ICU admission rate. Timepoint: First 24 and 72 hours and first 1 months after bleeding. Method of measurement: Data gathering sheet.;Mortality rate. Timepoint: First 24 and 72 hours and first 1 months after bleeding. Method of measurement: Data gathering sheet.;Endoscopic time in early endoscopy. Timepoint: Early endoscopic time in first 24 hours. Method of measurement: Time frame in minute.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Saadegh Ghafoori

Colorectal Research Center, Rasoul Akram Hospital

smsghafoori@gmail.com+98 21 6655 4790

Outcome results

None listed

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