Study Evaluating Liver Transplantation in Haemophilia Patients in Spain

Study Overview
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Brief Summary
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This study will analyze survival and outcome of patients with severe haemophilia who undergo liver transplantation in Spain

Detailed Description
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Probability Sample

Official Title
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Liver Transplantation in Haemophilia Patients in Spain

Conditions
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Hemophilia, Hemophilia B

Intervention / Treatment
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* Other: Epidemiological Non interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain. Exclusion Criteria: Patients without informed consent form.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with haemophilia who undergo liver transplantation<br>Patients with haemophilia who underwent liver transplantation and who have been followed up at any site in Spain. | Other: Epidemiological Non interventional<br>* Epidemiological Non interventional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation | Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation. | Post liver transplantation up to Month 3 | 
| Number of Participants With Acute Rejection of Liver Transplant | Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist. | Post liver transplantation up to Month 3 | 
| Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation | Number of participants who had liver transplantation after cirrhosis due to hepatitis C virus (HCV) infection and experienced recurrence of HCV infection post liver transplantation. | Post liver transplantation up to Month 3 | 
| Number of Participants Who Survived After Liver Transplantation | Number of participants who survived after liver transplantation was reported. The death reported was a result of acute-related transplantation complications and end-stage liver disease. | Post liver transplantation up to Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation | Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion. | Up to Day 5 post liver transplantation | 
| Dose of Exogenous Clotting Factors Used During Liver Transplantation | Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion. | Up to Day 5 post liver transplantation | 
| Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation |  | Post liver transplantation up to Month 3 |