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Trial record 3 of 29 for:    "Hemorrhagic Disease" | "Benzocaine"

Thromboelastometry in Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03011827
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : August 7, 2019
Information provided by (Responsible Party):
Annabel Blasi, Hospital Clinic of Barcelona

Brief Summary:
Thromboelastometry better assess coagulation than standard coagulation test in patients undergoing ortothopic liver transplantation. In a post-hoc analysis from a randomized study recently conducted by our group, presurgical values of MA10 Extem < 35 mm are highly predictive of RBC administration , with no further improvement over MA10 Extem >40 mm ; suggesting that MA10 Extem between 35-40 would be the optimal range to manage blood product administration. The aim of the study is to validate this result in a prospective cohort of patients submitted to ortothopic liver transplantation.

Condition or disease Intervention/treatment Phase
Liver Transplant Disorder Coagulopathy Other: Fibrinogen and/or platelets administration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transfusion Prediction Model in Orthotopic Liver Transplantation Based on Thromboelastometry: Prospective Validation Study.
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Arm Intervention/treatment
Experimental: Prospective cohort
Fibrinogen and/or platelet administration
Other: Fibrinogen and/or platelets administration
Fibrinogen and/or platelets administration to maintain clot amplitude at 10 minutes of the thromboelastometry between 35-40 mm along liver transplant procedure

Primary Outcome Measures :
  1. Red blood cell transfusion [ Time Frame: until 24h after liver transplant ]

Secondary Outcome Measures :
  1. Thrombosis [ Time Frame: 28 days after liver transplant ]
    Thrombosis will be assessed clinically and confirmed by ultrasonographic exam

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Presurgical hemoglobin < 13 d/L and clot firmness at 10 minutes Extem < 35 mm

Exclusion Criteria:

  • Previous thrombosis
  • Antithrombotic treatment
  • No consent

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 identifier (NCT number): NCT03011827

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Contact: Annabel Blasi, MD, PhD +34679500857

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Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Contact: Antoni Sabaté, Professor;   
Hospital de Cruces Not yet recruiting
Bilbao, Spain
Contact: Rosa Gutierrez, MD, PhD   
Sponsors and Collaborators
Hospital Clinic of Barcelona
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Principal Investigator: Annabel Blasi, MD, PhD Hospital Clinic Barcelona. IDIBAPS

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Responsible Party: Annabel Blasi, Anesthesiologist, Hospital Clinic of Barcelona Identifier: NCT03011827     History of Changes
Other Study ID Numbers: ATR100F
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders