Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT05698134
Eligibility Criteria:
Inclusion Criteria:
Patients with Cirrhosis undergoing elective procedure must meet all following criterias.
1. Patients undergoing the following elective procedures will be included in the study
1. Gastroscopy with endoscopic variceal ligation
2. Colonoscopy with polypectomy and endoscopic mucosal resection
3. ERCP with sphincterotomy
4. Percutaneous liver biopsy
5. Biopsy of other sites (excluding liver)
6. Hepatic venous pressure gradient with or without liver biopsy
7. Elective Transjugular Intrahepatic Portosystemic Shunt
8. Portal Vein embolization
9. Trans-arterial chemo-embolization (TACE)
10. Thermal ablation of hepatocellular carcinoma
11. Large volume paracentesis
12. Central venous catheter insertion
13. Thoracentesis
2. Age: Older than 21 years
3. Coagulopathy based on conventional coagulation tests which is defined as
1. INR \> 1.5 and/or aPTT \> 1.5x ULN for PTT and/or
2. Platelets \< 50,000/mm3/uL
4. Patients with acute decompensation, acute on chronic liver failure and acute liver failure.
5. Able to give informed consent.
Exclusion Criteria:
1. Emergency procedures. (defined as life-saving procedures)
2. On-going bleeding
3. Under 21 years of age
4. Inability to obtain informed consent from patients
5. Coagulation disorders (other than those relating to liver disease)
6. Patients on anticoagulant medications (e.g. warfarin, enoxaparin, rivaroxaban, dabigatran, apixaban, heparin, clexane etc.)
7. Patients on anti-platelet aggregation agents other than aspirin (e.g. clopidogrel, ticagrelor)
8. Active malignancy except hepatocellular carcinoma
9. Patients who have received FFP, platelet transfusion, cryoprecipitate within last 7 days
10. Patients with stage 4 or 5 chronic kidney disease
11. Patients receiving renal replacement therapy
12. Patients with active sepsis as defined by ACPP-SCCM criteria (21).
13. Pregnant Women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT05698134
Study Brief:
Protocol Section:
NCT05698134