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

NCT06014320 | Unknown

• 1 other identifier: 71275
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

liver transplant; hemophilia; coagulation; thrombosis; bleeding; cirrhosis

Outcome Measures

Primary Outcomes (3)

• Factor VIII level

  We will collect Factor VIII level pre- and post- transplant

  12 hours

• Factor IX level

  We will collect Factor IX level pre- and post- transplant

  12 hours

• Thromboelastography (TEG) values

  We will collect thromboelastography values pre- and post- transplant

  12 hours

Secondary Outcomes (1)

• Complications

  24 hours

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital

Palo Alto, California, 94305, United States

Location

Related 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.

  PMID: 29931985 BACKGROUND

• 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.

  PMID: 26390184 BACKGROUND

• 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.

  PMID: 8579741 BACKGROUND

• 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.

  PMID: 30328141 RESULT

MeSH Terms

Conditions

Liver Cirrhosis; Hemophilia A; Hemophilia B; Liver Failure; Thrombosis; Hemorrhage; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked; Hepatic Insufficiency; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexandra Ruan, MD

  Stanford University

  STUDY DIRECTOR

• Martin Angst, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Ruan, MD

CONTACT

650-723-4000; aruan@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 28, 2023
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)