Thromboelastometry in Liver Transplantation | NCT03011827

Studies
Thromboelastometry in Liver Transplantation

NCT03011827

Sponsor

Hospital Clinic of Barcelona

Status

Unknown status

Last Update Posted

Aug 7, 2019Actual

Enrollment

65Estimated

Phase

Not Applicable

Conditions

Liver Transplant Disorder
Coagulopathy

Interventions

Fibrinogen and/or platelets administration

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Sep 2022Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Jan 4, 2017

First Submission Date that Met QC Criteria

Jan 4, 2017

First Posted Date

Jan 5, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2019

Last Update Posted Date

Aug 7, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Annabel Blasi, Anesthesiologist, Hospital Clinic of BarcelonaPrincipal Investigator

Lead Sponsor

Hospital Clinic of BarcelonaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prospective cohort	Experimental	Fibrinogen and/or platelet administration	Other: Fibrinogen and/or platelets administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fibrinogen and/or platelets administration	Other	Fibrinogen and/or platelets administration to maintain clot amplitude at 10 minutes of the thromboelastometry between 35-40 mm along liver transplant procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Red blood cell transfusion		until 24h after liver transplant

Secondary Outcomes

Measure	Description	Time Frame
Thrombosis	Thrombosis will be assessed clinically and confirmed by ultrasonographic exam	28 days after liver transplant

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Annabel Blasi, MD, PhD	Contact	+34679500857		ablasi@clinic.ub.es

Overall Officials

Name	Affiliation	Role
Annabel Blasi, MD, PhD	Hospital Clinic Barcelona. IDIBAPS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari de Bellvitge	Recruiting	L'Hospitalet de Llobregat	Barcelona		Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020141	Hemostatic Disorders

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006474	Hemorrhagic Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided