Patients with cirrhosis and coagulopathy, indicated by a prolonged INR, who present with gastrointestinal bleeding. Cirrhosis, Coagulopathy, Gastrointestinal bleeding, Transfusion, Fresh frozen plasma
Conditions
Interventions
In the no plasma transfusion strategy group, no fresh frozen plasma (FFP) will be given before endoscopy,Two units of FFP with 10 mg of chlorpheniramine as premedication will be given before endoscopy
Experimental Procedure/Surgery,No Intervention Procedure/Surgery
No plasma transfusion,Control
Sponsors
Chulalongkorn University
Maharat Nakhon Ratchasima Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Cirrhosis patients diagnosed by clinical signs and/or liver function tests and/or imaging and/or liver biopsy, 2) Age 18 to 80 years, 3) The international normalized ratio (INR) between 1.5 and 2.5, and the INR level should be obtained no more than 1 month before recruitment. , 4) Patients presenting with upper gastrointestinal bleeding at either the emergency department or the outpatient clinic., 5) Intention for therapeutic endoscopy to address the bleeding lesion.
Exclusion criteria
Exclusion criteria: 1) Hereditary or acquired coagulopathy other than liver diseases, 2) Evidence of hemodynamic instability that requires inotropic support to sustain the mean arterial pressure (MAP) of 65 mmHg or more), 3) Uncontrolled infection with septic shock, 4) Renal insufficiency (CrCl less than 10 ml/min), 5) Taking antiplatelet and/or anticoagulant, 6) Receiving fresh frozen plasma before enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unit of red cell transfusion 14 days after admission Number of red cell unit | — |
Secondary
| Measure | Time frame |
|---|---|
| Unit of red cell transfusion within 6 hours 6 hour after endoscopy Extracted from electronic medical records,Unit of red cell transfusion 6-24 hours 6-24 hour after endoscopy Extracted from electronic medical records,Unit of red cell transfusion after 24 hours 24 hours after endoscopy until discharge or up to 14 days after hospitalization Extracted from electronic medical records,Hemoglobin 12-24 hours after endoscopy Extracted from electronic medical records,INR level 12-24 hours after endoscopy Extracted from electronic medical records,Time to endoscopy During hospitalization Extracted from electronic medical records,Number of platelet transfusion During hospitalization Extracted from electronic medical records,Number of plasma transfusion During hospitalization Extracted from electronic medical records,Volume of platelet transfusion During hospitalization Extracted from electronic medical records,Volume of plasma transfusion During hospitalization Extracted from electronic medical records,Transfusion related adverse event During hospitalization Extracted from electronic medical records,Bleeding complication 14 days after endoscopy Extracted from electronic medical records and patient report outcome,Length of hospital stay During hospitalization Extracted from electronic medical records,Length of ICU stay During hospitalization Extracted from electronic medical records,Mortality 1 and 3 months after endoscopy Extracted from electronic medical records and patient/relative report outcome | — |
Countries
Thailand
Contacts
Public ContactNuanrat Cheerasiri
Chulalongkorn University
Outcome results
None listed