CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-21

Study Completion Date

2019-03-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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%).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis

NCT03268668

Stroke, Acute Biological Specimen Banks Biomarkers +2 more

RECRUITING

Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke

NCT02893631

Stroke, Acute

COMPLETED

Impact of Cranioplasty On Cerebral Perfusion

NCT01113645

Head Injuries Subarachnoid Haemorrhage Intra-cerebral Haemorrhage +2 more

COMPLETED

Macrowire for IntracraNial Thrombectomy

NCT06148675

Stroke, Acute Ischemic

COMPLETED

Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture

NCT00823485

Aneurysm, Ruptured Subarachnoid Hemorrhage

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Hemorrhages

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prothrombin Complex Concentrate

Administration of a single dose of prothrombin complex concentrate (25 U/kg equivalent factor IX)

Group Type EXPERIMENTAL

Prothrombin Complex Concentrate

Intervention Type DRUG

Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S

Fresh Frozen Plasma

Administration of a single dose of fresh frozen plasma of 15 mL/kg

Group Type ACTIVE_COMPARATOR

Fresh Frozen Plasma

Intervention Type BIOLOGICAL

Pooled collection of plasma from donors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prothrombin Complex Concentrate

Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S

Intervention Type DRUG

Fresh Frozen Plasma

Pooled collection of plasma from donors

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No