Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanta University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Liver cirrhosis
Upper gastrointestinal bleeding
Disqualifiers
Patients aged < 18 years
Allergy to tranexamic acid
Allergy to vitamin K injection
DIC.
Trial design
Design model
Parallel
Treatments tested in this trial
Tranexamic Acid and vitamin K
DrugTranxemic 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.
Placebo
DrugIntravenous 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.
Treatment groups
194 Participants
are divided into 2 treatment groupsGroup A: Tranexamic acid and vitamin KExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rebleeding rate
The rate of rebleeding and need for blood transfusion at 5 days and 6 weeks will be evaluated and compared across the groups.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Mortality rate
The mortality rates at 5 days and 6 weeks will be evaluated and compared across the groups.
Time frame
through study completion, an average of 1 year2
adverse effects
Drug adverse effects at 5 days and 6 weeks will be evaluated and compared across the groups.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov