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

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ClinicalTrials.gov Identifier: NCT06014320

Recruitment Status : Not yet recruiting

First Posted : August 28, 2023

Last Update Posted : August 28, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Alexandra Ruan, Stanford University

Study Description

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.

Condition or disease
Liver Cirrhosis Hemophilia Hemophilia A Hemophilia B Liver Transplant Disorder Liver Failure Coagulation Factor Deficiency

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 Design

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Study Type :	Observational
Estimated Enrollment :	25 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Understanding the Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease
Estimated Study Start Date :	October 1, 2023
Estimated Primary Completion Date :	April 1, 2024
Estimated Study Completion Date :	October 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hemophilia

MedlinePlus related topics: Liver Diseases

Genetic and Rare Diseases Information Center resources: Hemophilia Hemophilia B Hemophilia A

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
ESLD All participants recruited will belong to this group. These participants will all have end stage liver disease and be listed for liver transplant with an accepted organ offer.

Outcome Measures

Primary Outcome Measures :

Factor VIII level [ Time Frame: 12 hours ]
We will collect Factor VIII level pre- and post- transplant
Factor IX level [ Time Frame: 12 hours ]
We will collect Factor IX level pre- and post- transplant
Thromboelastography (TEG) values [ Time Frame: 12 hours ]
We will collect thromboelastography values pre- and post- transplant

Secondary Outcome Measures :

Complications [ Time Frame: 24 hours ]
We will collect data on bleeding or clotting events during the liver transplant surgery and 24 hours post-operatively

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Participants will be recruited for the study who have end stage liver disease and are undergoing liver transplant at Stanford hospital

Criteria

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06014320

Contacts

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Contact: Alexandra Ruan, MD	650-723-4000	aruan@stanford.edu

Locations

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United States, California
Stanford Hospital
Palo Alto, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

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Study Director:	Alexandra Ruan, MD	Stanford University
Principal Investigator:	Martin Angst, MD	Stanford University

More Information

Publications of Results:

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 7.

Other Publications:

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.

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.

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.

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Responsible Party:	Alexandra Ruan, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier:	NCT06014320
Other Study ID Numbers:	71275
First Posted:	August 28, 2023 Key Record Dates
Last Update Posted:	August 28, 2023
Last Verified:	August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Alexandra Ruan, Stanford University:


liver transplant hemophilia coagulation	thrombosis bleeding cirrhosis

Additional relevant MeSH terms:

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Liver Diseases Liver Cirrhosis Liver Failure End Stage Liver Disease Hemophilia A Hemophilia B Fibrosis Digestive System Diseases Pathologic Processes	Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Hepatic Insufficiency Genetic Diseases, X-Linked

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