Thromboelastometry in Liver Transplantation

Coagulopathy Clinical Trial

Official title:

Transfusion Prediction Model in Orthotopic Liver Transplantation Based on Thromboelastometry: Prospective Validation Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03011827
• Other study ID #: ATR100F
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 2022

Study information

• Verified date: August 2019
• Source: Hospital Clinic of Barcelona
• Contact: Annabel Blasi, MD, PhD
• Phone: +34679500857
• Email: ablasi[@]clinic.ub.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: October 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previous thrombosis

• Antithrombotic treatment

• No consent

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• Hemostatic Disorders
• Liver Transplant Disorder

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital de Cruces	Bilbao
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Red blood cell transfusion		until 24h after liver transplant
Secondary	Thrombosis	Thrombosis will be assessed clinically and confirmed by ultrasonographic exam	28 days after liver transplant