Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease

Not yet recruiting

• Conditions: Hemophilia; Coagulation Factor Deficiency; Liver Cirrhosis; Hemophilia A; Hemophilia B; Liver Transplant Disorder; Liver Failure

• Registration Number: NCT06014320
• Lead Sponsor: Stanford University

Brief Summary

The goal of this observational study is to learn about the changes in coagulation factor VIII and IX levels in patients undergoing liver transplantation to help guide future management of coagulation factor replacement in patients with hemophilia and liver disease. The question we aim to answer is: should the recommendations for factor replacement in patients with hereditary bleeding disorders be altered in the setting of end stage liver cirrhosis?

Participants will be asked to provide two blood samples, one at the beginning of their liver transplant, and one after their liver transplant.

Detailed Description

Current guidelines for management of hemophilia B suggest replacement of factor IX to 100% prior to major abdominal surgery. However, in patients with concurrent liver cirrhosis where the liver does not produce Factor IX, is it worth considering adjusting the factor replacement strategy? We recently had a case of a patient with Hemophilia B and end-stage liver disease (ESLD) who underwent orthotopic liver transplantation and received the standard pre-operative recombinant factor IX replacement. His case was complicated by intra-cardiac thrombus and hypotension. We conduct a small study to assess the pre-operative thromboelastography (TEG) and factor levels in ESLD patient which we hope will help guide clinical decision making in future hemophilia B patients with cirrhosis.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-23
• Last Update Submitted: 2023-08-23
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28
• Study Start: 2023-10-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• participants who have end stage liver disease who are listed for liver transplantation and have an accepted organ offer
• age > 18+
• MELD > 25

Exclusion Criteria

• undergoing multi-organ transplant
• tumor MELD exception points
• has hereditary coagulation disease
• currently on therapeutic blood thinner or anti-platelet medication (ie. aspirin, plavix, warfarin, heparin)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Factor IX level	12 hours	We will collect Factor IX level pre- and post- transplant
Factor VIII level	12 hours	We will collect Factor VIII level pre- and post- transplant
Thromboelastography (TEG) values	12 hours	We will collect thromboelastography values pre- and post- transplant

Secondary Outcome Measures

Name	Time	Method
Complications	24 hours	We will collect data on bleeding or clotting events during the liver transplant surgery and 24 hours post-operatively

Trial Locations

Locations (1)

Stanford Hospital; 🇺🇸 Palo Alto, California, United States