CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients (CLOT-CRANE)

February 1, 2022 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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%).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France, 59037
      • Nancy, France, 54000
      • Paris, France, 75019
        • Recruiting
        • Fondation Ophtalmologique Adolphe de Rothschild (FOR)
        • Contact:
        • Principal Investigator:
          • Marine DE MESMAY, MD
      • Suresnes, France, 92150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prothrombin Complex Concentrate
Administration of a single dose of prothrombin complex concentrate (25 U/kg equivalent factor IX)
Drug: Prothrombin Complex Concentrate
Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C & S
Active Comparator: Fresh Frozen Plasma
Administration of a single dose of fresh frozen plasma of 15 mL/kg
Biological: Fresh Frozen Plasma
Pooled collection of plasma from donors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with correction of prothrombin time (PT more than 60%)
Time Frame: End of treatment administration (an average of 1 hour)
End of treatment administration (an average of 1 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

July 21, 2020

Study Completion (Anticipated)

July 27, 2022

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

February 2, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGR_2014-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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