Controlled Donors After Circulatory Death and Brain Death... | NCT04945135

Studies
Controlled Donors After Circulatory Death and Brain Death: a Multicenter Study of Transfusion, One-year Graft Survival and Mortality. Cohort Study,

NCT04945135

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

Jun 30, 2021Actual

Enrollment

591Actual

Phase

Not provided

Conditions

Liver Transplant

Interventions

Not provided

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

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Jun 25, 2021Actual

First Submitted Date

Jun 25, 2021

First Submission Date that Met QC Criteria

Jun 25, 2021

First Posted Date

Jun 30, 2021Actual

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

Jun 25, 2021

Last Update Posted Date

Jun 30, 2021Actual

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

RBC requirement ein DBD and DCD liver transplants

Detailed Description

Background: Controlled donation after cardiac circulatory death (cDCD) is accepted to expand the donor pool for liver transplantation (LT). However, transfusion requirements and perioperative outcomes should be elucidated. The aims of this multicentre study are to assess the red blood cell (RBC) transfusions, one-year graft and patient survival after LT with cDCD compared to donors after brain dead (DBD).

Methods: 591 LT patients conducted in ten centers during 2019 were reviewed. Thromboelastometry was used to manage coagulation and blood product transfusion in all centres. Normothermic regional perfusion was the standard technique for organ recovery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

591Actual

Label	Type	Description	Intervention Names
liver donors

Measure	Description	Time Frame
RBC transfusion		intraoperative

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing LT

Exclusion Criteria:

acute liver failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients undergoing LT

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided