CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients (CLOT-CRANE)
Primary Purpose
Intracranial Hemorrhages
Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Prothrombin Complex Concentrate
Fresh Frozen Plasma
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Hemorrhages
Eligibility Criteria
Inclusion Criteria:
- Patient with spontaneous intracranial hemorrhage or traumatic intracranial hemorrhage or patient requiring neurological surgery
- Coagulation disorder defined by PT less than 60%
Exclusion Criteria:
- Concomitant use with oral anticoagulant drugs
- Acquired deficiency of coagulation factors whose treatment is established
- Hypersensitivity to a PCC
- History of thrombocytopenia induced by heparin
- Disseminated intravascular coagulation
- Extracranial active bleeding
- Hypersensitivity to vitamin K
Sites / Locations
- CHU de Lille
- CHU de NANCYRecruiting
- Fondation Ophtalmologique Adolphe de Rothschild (FOR)Recruiting
- Hôpital Foch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prothrombin Complex Concentrate
Fresh Frozen Plasma
Arm Description
Administration of a single dose of prothrombin complex concentrate (25 U/kg equivalent factor IX)
Administration of a single dose of fresh frozen plasma of 15 mL/kg
Outcomes
Primary Outcome Measures
Proportion of patients with correction of prothrombin time (PT more than 60%)
Secondary Outcome Measures
Full Information
NCT ID
NCT02777424
First Posted
May 12, 2016
Last Updated
February 1, 2022
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT02777424
Brief Title
CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients
Acronym
CLOT-CRANE
Official Title
Prothrombin Complex Concentrate Versus Fresh Frozen Plasma to Correct Coagulation Disorders in Adult Neurosurgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 21, 2020 (Actual)
Study Completion Date
July 27, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
5. Study Description
Brief Summary
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%).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hemorrhages
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prothrombin Complex Concentrate
Arm Type
Experimental
Arm Description
Administration of a single dose of prothrombin complex concentrate (25 U/kg equivalent factor IX)
Arm Title
Fresh Frozen Plasma
Arm Type
Active Comparator
Arm Description
Administration of a single dose of fresh frozen plasma of 15 mL/kg
Intervention Type
Drug
Intervention Name(s)
Prothrombin Complex Concentrate
Intervention Description
Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C & S
Intervention Type
Biological
Intervention Name(s)
Fresh Frozen Plasma
Intervention Description
Pooled collection of plasma from donors
Primary Outcome Measure Information:
Title
Proportion of patients with correction of prothrombin time (PT more than 60%)
Time Frame
End of treatment administration (an average of 1 hour)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with spontaneous intracranial hemorrhage or traumatic intracranial hemorrhage or patient requiring neurological surgery
Coagulation disorder defined by PT less than 60%
Exclusion Criteria:
Concomitant use with oral anticoagulant drugs
Acquired deficiency of coagulation factors whose treatment is established
Hypersensitivity to a PCC
History of thrombocytopenia induced by heparin
Disseminated intravascular coagulation
Extracranial active bleeding
Hypersensitivity to vitamin K
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence SALOMON
Email
lsalomon@for.paris
Facility Information:
Facility Name
CHU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit TAVERNIER
Email
Benoit.TAVERNIER@CHRU-LILLE.FR
Facility Name
CHU de NANCY
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gérard AUDIBERT, MD
Phone
0033383851403
Email
g.audibert@chu-nancy.fr
Facility Name
Fondation Ophtalmologique Adolphe de Rothschild (FOR)
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence SALOMON, MD, PhD
Email
lsalomon@for.paris
First Name & Middle Initial & Last Name & Degree
Marine DE MESMAY, MD
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc fischler
Email
m.fischler@hopital-foch.org
12. IPD Sharing Statement
Learn more about this trial
CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients
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