Interest in Evaluating Primary Hemostasis in Patients Wit... | NCT03248596

Studies
Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO)

NCT03248596

Sponsor

Rennes University Hospital

Status

Terminated

Last Update Posted

Nov 21, 2017Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Patients With ECMO

Interventions

Not provided

Countries

France

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Obsolete study

Expanded Access Info

Start Date

Feb 2016Actual

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Aug 9, 2017

First Submission Date that Met QC Criteria

Aug 9, 2017

First Posted Date

Aug 14, 2017Actual

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

Nov 17, 2017

Last Update Posted Date

Nov 21, 2017Actual

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

The aim of the study is a better understanding of hemorrhagic events causes in patients with ECMO, prevent them and decrease the number of transfusion.

Detailed Description

The most frequent complication during ECMO is hemorrhage especially as a curative anticoagulant treatment is necessary. The primary hemostasis is also affected with a von Willebrand disease and thrombopathy, well known but not studied by recent tests.The identification of primary haemostasis deficits with these tools would allow to supply them and decrease the morbi-mortality related to the transfusion.

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

5Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate primary hemostasis in patient with ECMO at University Hospital of Rennes		Day 5

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient older than 18 years old
Patient with ECMO
Patient hospitalized in an intensive care unit at the University Hospital of Rennes

Exclusion Criteria:

Known history for constitutional pathology of the primary haemostasis
Platelets < 100000 / mm3 or hematocrit < 28 % between H+12 and H+24

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

Patient with ECMO

Sampling Method

Non-Probability Sample