NCT03011827

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
2.6 years until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

3.1 years

First QC Date

January 4, 2017

Last Update Submit

August 6, 2019

Conditions

Liver Transplant DisorderCoagulopathy

Outcome Measures

Primary Outcomes (1)

  • Red blood cell transfusion

    until 24h after liver transplant

Secondary Outcomes (1)

  • Thrombosis

    28 days after liver transplant

Study Arms (1)

Prospective cohort

EXPERIMENTAL

Fibrinogen and/or platelet administration

Other: Fibrinogen and/or platelets administration

Interventions

Fibrinogen and/or platelets administrationOTHER

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

Prospective cohort

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous thrombosis
  • Antithrombotic treatment
  • No consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Hospital de Cruces

Bilbao, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Annabel Blasi, MD, PhD

    Hospital Clinic Barcelona. IDIBAPS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annabel Blasi, MD, PhD

CONTACT

+34679500857ablasi@clinic.ub.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 5, 2017

Study Start

August 1, 2019

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

ES(2)