Loading clinical trials...
Loading clinical trials...
Prothrombin Complex Concentrate Versus Fresh Frozen Plasma to Correct Coagulation Disorders in Adult Neurosurgical Patients
This prospective, randomized, multicenter study is performed to determine whether prothrombin complex concentrates confers any benefits over fresh frozen plasma in adult neurological patients with coagulation disorders (PT value less than 60%).
The coagulation disorders increase the risk of bleeding and are a risk factor of intracranial hemorrhagic complications in neurosurgical patients. They are diagnosed more often in emergency on a PT value less than 60% and so they should be corrected as soon as possible. Two therapeutic strategies are proposed by French or international recommendations: transfusion of fresh frozen plasma (FFP) or administration of prothrombin complex concentrates (PCC). This prospective, randomized, multicenter study with blinded assessment of the primary endpoint, is performed to determine whether PCC confers any benefits over FFP in the neurological patients with coagulation disorders.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU de Lille
Lille, France
CHU de NANCY
Nancy, France
Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Paris, France
Hôpital Foch
Suresnes, France
Start Date
January 21, 2016
Primary Completion Date
March 27, 2019
Completion Date
March 27, 2019
Last Updated
June 5, 2024
18
ACTUAL participants
Prothrombin Complex Concentrate
DRUG
Fresh Frozen Plasma
BIOLOGICAL
Lead Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05300672