Prognosis Related to Induced Thrombopenia With Heparin Un... | NCT03979625

Studies
Prognosis Related to Induced Thrombopenia With Heparin Under Venoarterial ECMO in Reanimation

NCT03979625

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Jun 7, 2019Actual

Enrollment

39Actual

Phase

Not provided

Conditions

Heparin-induced Thrombocytopenia

Interventions

Hospitalization for more than 3 days with high clinical suspicion of HIT and positive anti-PF4/heparin antibodies

Countries

Not provided

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 2019

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

Jan 1, 2016Actual

Primary Completion Date

Apr 30, 2018Actual

Completion Date

Apr 30, 2018Actual

First Submitted Date

Jun 6, 2019

First Submission Date that Met QC Criteria

Jun 6, 2019

First Posted Date

Jun 7, 2019Actual

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 6, 2019

Last Update Posted Date

Jun 7, 2019Actual

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

Thrombocytopenia is a frequent and serious adverse event in patients treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for refractory cardiogenic shock. Similarly to postcardiac surgery patients, heparin-induced thrombocytopenia (HIT) could represent the causative underlying mechanism. However, the epidemiology as well as related mortality regarding HIT and VA-ECMO remains largely unknown. The investigators aimed to define the prevalence and associated 90-day mortality of HIT diagnosed under VA-ECMO.This retrospective study included patients under VA-ECMO from 20 French centers between 2012 and 2016.

Detailed Description

Not provided

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

39Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hospitalization for more than 3 days with high clinical suspicion of HIT and positive anti-PF4/heparin antibodies	Other	Patients are classified according to results of functional tests as having either Confirmed or Excluded HIT.

Measure	Description	Time Frame
Death		90 days after inclusion

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Patient hospitalized in intensive care for a cardiovascular failure requiring the setting up of an ECMO-VA
ECMO-VA duration ≥ 3 days
HIT confirmed by immunological tests
Patient affiliated to a Social Security scheme

Exclusion Criteria:

Known antecedent of TIH prior to cannulation
Pregnant woman
ECMO-VA following cardiopulmonary arrest or septic shock

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 hospitalized in intensive care for cardiogenic shock requiring cardiac assisting with ECMO-VA.

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D006760	Hospitalization

Ancestor Terms

ID	Term
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided