Cirrhosis, Upper Gastrointestinal Bleeding (UGIB), Variceal Bleeding
Conditions
Keywords
Variceal bleeding, Tranexamic acid and vitamin K, Liver cirrhosis
Brief summary
The goal of this randomized controlled clinical trial is to evaluate the efficacy of Tranexamic acid and vitamin K injection versus placebo in control of upper gastrointestinal bleeding (UGIB) in Egyptian cirrhotic patients. Researchers will compare the bleeding and mortality rates (at 5 days and 6 weeks post endoscopic intervention for UGIB) between patients receiving tranxemic acid and vitamin K injection and patients receiving placebo. Participants presenting with variceal bleeding will be randomly assigned to receive tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h or matching placebo group receiving IV saline. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy. Follow-up All patients will be kept at the hospital for at least 5 days from the index bleed and will be discharged if no other reason was observed to keep them at the hospital. The rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate were evaluated and compared across the groups. At discharge, all patients will be started on nonselective beta-blockers if there was no contraindication. They will be given instructions to attend to hospital if they noticed any melena or hematemesis. Second follow-up after 6 weeks for the rebleeding rate and mortality related to bleeding rate.
Interventions
DRUGTranexamic Acid and vitamin K
Tranxemic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection (10 mg daily of vitamin K for 24-48 h) along with initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy to control UGIB in cirrhotic patients. Patients will be followed up after 5 days and 6 weeks to assess the rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate.
DRUGPlacebo
Intravenous saline over 24-48 hours along with initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy to control UGIB in cirrhotic patients. Patients will be followed up after 5 days and 6 weeks to assess the rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Liver cirrhosis * Upper gastrointestinal bleeding
Exclusion criteria
* Patients aged \< 18 years * Allergy to tranexamic acid * Allergy to vitamin K injection * DIC. * Thromboembolic event. * Pregnancy or lactation. * End-stage renal disease. * Unwilling to participate in our study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rebleeding rate | through study completion, an average of 1 year | The rate of rebleeding and need for blood transfusion at 5 days and 6 weeks will be evaluated and compared across the groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | through study completion, an average of 1 year | The mortality rates at 5 days and 6 weeks will be evaluated and compared across the groups. |
| adverse effects | through study completion, an average of 1 year | Drug adverse effects at 5 days and 6 weeks will be evaluated and compared across the groups. |
Countries
Egypt
Contacts
Primary ContactRania M Elkafoury, MD
Backup ContactMennat-Allah M El Sawaf, MD
Outcome results
None listed