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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fibrinogen in Liver Transplant

NCT07265843

Liver Transplant Surgery

NOT_YET_RECRUITING PHASE4

Fibrinogen and Intraoperative Bleeding in Liver Transplant

NCT04925843

End Stage Liver DIsease Liver Transplant; Complications

COMPLETED

Thrombin Generation in Liver Transplant Surgery

NCT04762550

Liver Transplantation Thrombin Hemostasis, Surgical +2 more

UNKNOWN

Investigation of Systemic and Regional Haemostasis During Liver Transplantation by Comparing ClotPro® and TEG®

NCT04246307

Haemostasis Disorders

UNKNOWN

Fibrinogen in Liver Transplant Subjects

NCT06764927

Liver Transplant Surgery

NOT_YET_RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No