Thromboelastometry in Liver Transplantation

NCT ID: NCT03011827

Last Updated: 2019-08-07

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Transplant Disorder Coagulopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prospective cohort

Fibrinogen and/or platelet administration

Group Type EXPERIMENTAL

Fibrinogen and/or platelets administration

Intervention Type OTHER

Fibrinogen and/or platelets administration to maintain clot amplitude at 10 minutes of the thromboelastometry between 35-40 mm along liver transplant procedure

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previous thrombosis
* Antithrombotic treatment
* No consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Annabel Blasi

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annabel Blasi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic Barcelona. IDIBAPS

Locations

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Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Hospital de Cruces

Bilbao, , Spain

Site Status NOT_YET_RECRUITING

Countries

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Spain

Central Contacts

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Annabel Blasi, MD, PhD

Role: CONTACT

+34679500857

Facility Contacts

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Antoni Sabaté, Professor

Role: primary

Rosa Gutierrez, MD, PhD

Role: primary

Other Identifiers

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ATR100F

Identifier Type: -

Identifier Source: org_study_id

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