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Thromboelastometry in Liver Transplantation

Primary Purpose

Liver Transplant Disorder, Coagulopathy

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Fibrinogen and/or platelets administration
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Transplant Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous thrombosis
  • Antithrombotic treatment
  • No consent

Sites / Locations

  • Hospital Universitari de BellvitgeRecruiting
  • Hospital de Cruces

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prospective cohort

Arm Description

Fibrinogen and/or platelet administration

Outcomes

Primary Outcome Measures

Red blood cell transfusion

Secondary Outcome Measures

Thrombosis
Thrombosis will be assessed clinically and confirmed by ultrasonographic exam

Full Information

First Posted
January 4, 2017
Last Updated
August 6, 2019
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT03011827
Brief Title
Thromboelastometry in Liver Transplantation
Official Title
Transfusion Prediction Model in Orthotopic Liver Transplantation Based on Thromboelastometry: Prospective Validation Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplant Disorder, Coagulopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prospective cohort
Arm Type
Experimental
Arm Description
Fibrinogen and/or platelet administration
Intervention Type
Other
Intervention Name(s)
Fibrinogen and/or platelets administration
Intervention Description
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 Measure Information:
Title
Red blood cell transfusion
Time Frame
until 24h after liver transplant
Secondary Outcome Measure Information:
Title
Thrombosis
Description
Thrombosis will be assessed clinically and confirmed by ultrasonographic exam
Time Frame
28 days after liver transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presurgical hemoglobin < 13 d/L and clot firmness at 10 minutes Extem < 35 mm Exclusion Criteria: Previous thrombosis Antithrombotic treatment No consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annabel Blasi, MD, PhD
Phone
+34679500857
Email
ablasi@clinic.ub.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annabel Blasi, MD, PhD
Organizational Affiliation
Hospital Clinic Barcelona. IDIBAPS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoni Sabaté, Professor
Email
asabatep@ub.edu; asabatep@bellvitgehospital.cat
Facility Name
Hospital de Cruces
City
Bilbao
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Gutierrez, MD, PhD
Email
rogurico@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Thromboelastometry in Liver Transplantation

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