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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06014320
• Other study ID #: 71275
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: Alexandra Ruan, MD
• Phone: 650-723-4000
• Email: aruan[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: October 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coagulation Factor Deficiency
• End Stage Liver Disease
• Fibrosis
• Hemophilia
• Hemophilia A
• Hemophilia B
• Liver Cirrhosis
• Liver Diseases
• Liver Failure
• Liver Transplant Disorder

Locations

Country	Name	City	State
United States	Stanford Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Alonso Madrigal C, Dobon Rebollo M, Laredo de la Torre V, Palomera Bernal L, Garcia Gil FA. Liver transplantation in hemophilia A and von Willebrand disease type 3: perioperative management and post-transplant outcome. Rev Esp Enferm Dig. 2018 Aug;110(8):522-526. doi: 10.17235/reed.2018.5204/2017. — View Citation

Kadry Z, de Moerloose P, Giostra E, Morel P, Huber O, Meili E, Blum HE, Mentha G. Orthotopic liver transplantation in hemophilia B: a case report. Transpl Int. 1995;8(6):485-7. doi: 10.1007/BF00335602. — View Citation

Ramiz S, Hartmann J, Young G, Escobar MA, Chitlur M. Clinical utility of viscoelastic testing (TEG and ROTEM analyzers) in the management of old and new therapies for hemophilia. Am J Hematol. 2019 Feb;94(2):249-256. doi: 10.1002/ajh.25319. Epub 2018 Dec — View Citation

Togashi J, Akamatsu N, Tanaka T, Sugawara Y, Tsukada K, Kaneko J, Arita J, Sakamoto Y, Hasegawa K, Kokudo N. Living donor liver transplantation for hemophilia with special reference to the management of perioperative clotting factor replacement. Liver Transpl. 2016 Mar;22(3):366-70. doi: 10.1002/lt.24341. Epub 2016 Feb 15. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factor VIII level	We will collect Factor VIII level pre- and post- transplant	12 hours
Primary	Factor IX level	We will collect Factor IX level pre- and post- transplant	12 hours
Primary	Thromboelastography (TEG) values	We will collect thromboelastography values pre- and post- transplant	12 hours
Secondary	Complications	We will collect data on bleeding or clotting events during the liver transplant surgery and 24 hours post-operatively	24 hours