Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease
Study Details
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 | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 [12 hours]
We will collect Factor VIII level pre- and post- transplant
- Factor IX level [12 hours]
We will collect Factor IX level pre- and post- transplant
- Thromboelastography (TEG) values [12 hours]
We will collect thromboelastography values pre- and post- transplant
Secondary Outcome Measures
- Complications [24 hours]
We will collect data on bleeding or clotting events during the liver transplant surgery and 24 hours post-operatively
Eligibility Criteria
Criteria
Inclusion Criteria:
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participants who have end stage liver disease who are listed for liver transplantation and have an accepted organ offer
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age > 18+
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MELD > 25
Exclusion Criteria:
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undergoing multi-organ transplant
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tumor MELD exception points
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has hereditary coagulation disease
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currently on therapeutic blood thinner or anti-platelet medication (ie. aspirin, plavix, warfarin, heparin)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford Hospital | Palo Alto | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
Investigators
- Study Director: Alexandra Ruan, MD, Stanford University
- Principal Investigator: Martin Angst, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
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.
- 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.
- 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.
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