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Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation (HHT)

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ClinicalTrials.gov Identifier: NCT03942315
Recruitment Status : Completed
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
Liver transplantation (LT) has been proposed as a curative treatment in hereditary hemorrhagic telangiectasia (HHT) with severe hepatic involvement. The investigating team provides a long-term evaluation of graft status after LT for HHT with a focus on the risk of recurrence. The present study included all patients prospectively followed up after LT for HHT in the Lyon Liver Transplant Unit from 1993 to 2010 with a survival of more than 1 year.

Condition or disease Intervention/treatment
Hereditary Haemorrhagic Telangiectasia Liver Transplant Other: Data collection from standard follow-up after liver transplant

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation: Clinical Implications and Physiopathological Insights.
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : December 1, 2018


Group/Cohort Intervention/treatment
Liver transplant in Hereditary Hemorrhagic Telangiectasia
Hereditary Hemorrhagic Telangiectasia (HHT) patients who underwent a liver transplant in Lyon between 1993 and 2010, and who survived more than 1 year after transplantation.
Other: Data collection from standard follow-up after liver transplant
All patients underwent regular follow-up every 6 to 12 months after the first year post-liver transplant (LT). Complete laboratory investigations were performed at each visit. Doppler ultrasonography was performed every 1 to 3 years after LT. Computed tomography (CT) scan and/ or magnetic resonance imaging (MRI) was performed at 1, 5, 10, 15, and 20 years after LT, or when clinically indicated. All available radiological material was reviewed. Cardiac evaluation was performed regularly in patients who received transplant for cardiac failure.




Primary Outcome Measures :
  1. Change in graft status after liver transplant for Hereditary Haemorrhagic Telangiectasia (HHT) (risk of recurrence) [ Time Frame: Every 6 months after transplantation up to 5 years ]
    Recurrent clinical examinations (including laboratory, histological and radiological investigations)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant
Criteria

Inclusion Criteria:

  • Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant for HHT

Exclusion Criteria:

  • Patient who died in the year following transplantation

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): NCT03942315


Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Jérôme DUMORTIER, MD Hospices Civils de Lyon (Hôpital Edouard Herriot )

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03942315     History of Changes
Other Study ID Numbers: HHT
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Telangiectasia, Hereditary Hemorrhagic
Disease Attributes
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Telangiectasis
Recurrence
Pathologic Processes
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Liver Extracts
Hematinics