CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients
CLOT-CRANE
Prothrombin Complex Concentrate Versus Fresh Frozen Plasma to Correct Coagulation Disorders in Adult Neurosurgical Patients
1 other identifier
interventional
18
1 country
4
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%).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2016
Typical duration for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2016
CompletedFirst Submitted
Initial submission to the registry
May 12, 2016
CompletedFirst Posted
Study publicly available on registry
May 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2019
CompletedJune 5, 2024
June 1, 2024
3.2 years
May 12, 2016
June 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with correction of prothrombin time (PT more than 60%)
End of treatment administration (an average of 1 hour)
Study Arms (2)
Prothrombin Complex Concentrate
EXPERIMENTALAdministration of a single dose of prothrombin complex concentrate (25 U/kg equivalent factor IX)
Fresh Frozen Plasma
ACTIVE COMPARATORAdministration of a single dose of fresh frozen plasma of 15 mL/kg
Interventions
Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S
Eligibility Criteria
You may qualify if:
- Patient with spontaneous intracranial hemorrhage or traumatic intracranial hemorrhage or patient requiring neurological surgery
- Coagulation disorder defined by PT less than 60%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU de Lille
Lille, 59037, France
CHU de NANCY
Nancy, 54000, France
Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Paris, 75019, France
Hôpital Foch
Suresnes, 92150, France
Related Publications (1)
Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
PMID: 37870112DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2016
First Posted
May 19, 2016
Study Start
January 21, 2016
Primary Completion
March 27, 2019
Study Completion
March 27, 2019
Last Updated
June 5, 2024
Record last verified: 2024-06