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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03248596
Other study ID # 35RC15_3023_ECMO PFA-100
Secondary ID
Status Terminated
Phase N/A
First received August 9, 2017
Last updated November 17, 2017
Start date February 2016
Est. completion date July 2016

Study information

Verified date November 2017
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU de Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate primary hemostasis in patient with ECMO at University Hospital of Rennes Day 5