Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Tranexamic Acid: Tranexamic Acid 1g iv bolus as loading dose followed by 3g Tranexamic Acid infused over next 24 hours
Control Intervention1: Placebo: Normal Saline
Control Intervention
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients greater than 18 years of age 2.Presenting with Acute UGI bleed (less than 24 hrs from onset) 3.Cirrhosis (Known Or suspected on clinical, biological, radiological data or the patient history) with CTP B or C (i.e. CTP greater than equals to 7) or ACLF (with clinical evidence of cirrhosis)
Exclusion criteria
Exclusion criteria: 1. Non cirrhotic patients 2. Known allergy to Tranexamic Acid 3. Patients with clinical evidence of DIC (Disseminated Intravascular Coagulation) like coagulopathy patches/ haematuria / uncontrolled epistaxis etc. 4. Patients with Chronic Kidney Disease. 5. History of recent Cerebro Vascular Accident (CVA) [in the past 6 months] or patients with thrombotic events [Portal Vein thrombosis /Hepatic vein thrombosis /other sites thrombosis]. HCC with tumour thrombosis will be included 6. Any history of seizures, myocardial infarction 7. Pregnancy/lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients developing five-day treatment failure (i.e., failure to control bleed)Timepoint: 5 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood product and component requirementsTimepoint: 6 weeks;Clinically significant rebleed within 6 weeks (monitored by hemoglobin drop by 3g/dl, need of blood transfusion)Timepoint: 6 weeks;Days of ICU/hospital stayTimepoint: 6 weeks;Failure to prevent rebleed within 6 weeksTimepoint: 6 weeks;Mortality attributed to failure to control bleed.Timepoint: 6 weeks;Need for salvage therapy (tamponade, additional endoscopic therapy, TIPS, surgery etc.)Timepoint: 6 weeks;Other complications post bleed (including other significant cardiac event, sepsis, pneumonia, respiratory failure, Acute Kidney Injury, seizures etc)Timepoint: 6 weeks;Thromboembolic events (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction etc)Timepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactDr Manoj Kumar Sharma
Institute of Liver and Biliary Sciences
Outcome results
None listed