Intracranial HemorrhagesPhase 4CLOT-CRANENCT02777424
CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients
A Phase 4 study testing Prothrombin Complex Concentrate and Fresh Frozen Plasma in people with Intracranial Hemorrhages, run by Fondation Ophtalmologique Adolphe de Rothschild at 4 sites in France.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhages
- What is being tested?
- Prothrombin Complex Concentrate and Fresh Frozen Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesFrance
- Study dates
- 21 Jan 2016to 27 Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with spontaneous intracranial hemorrhage or traumatic intracranial hemorrhage or patient requiring neurological surgery
- Coagulation disorder defined by PT less than 60%
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de Lille
Lille, 59037
CHU de NANCY
Nancy, 54000
Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Paris, 75019
Hôpital Foch
Suresnes, 92150
About this study
Official title: 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%).
Read the 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.
- Conditions
- Intracranial Hemorrhages
- Being tested
- Prothrombin Complex Concentrate, Fresh Frozen Plasma
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prothrombin Complex ConcentrateDrug
Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S
Fresh Frozen PlasmaBiological
Pooled collection of plasma from donors
| Study group | Role | What they receive |
|---|---|---|
| Prothrombin Complex Concentrate | Experimental | Administration of a single dose of prothrombin complex concentrate (25 U/kg equivalent factor IX) Receives: Drug: Prothrombin Complex Concentrate |
| Fresh Frozen Plasma | Active comparator | Administration of a single dose of fresh frozen plasma of 15 mL/kg Receives: Biological: Fresh Frozen Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with correction of prothrombin time (PT more than 60%)
Measured: End of treatment administration (an average of 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start21 Jan 2016
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777424
- Sponsor's protocol ID
- AGR_2014-22
- Acronym
- CLOT-CRANE
- Status last verified
- Jun 2024
- First submitted
- 12 May 2016
- Last updated
- 5 Jun 2024
- Results posted
- No
Publications
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.
PubMed 37870112
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prothrombin Complex Concentrate Versus Fresh Frozen Plasma to Correct Coagulation Disorders in Adult Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT02777424
- Acronym / sponsor ID
- CLOT-CRANE / AGR_2014-22
- Conditions
- Intracranial Hemorrhages
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 21 Jan 2016 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prothrombin Complex Concentrate | Experimental | Drug: Prothrombin Complex ConcentrateAdministration of a single dose of prothrombin complex concentrate (25 U/kg equivalent factor IX) |
| Fresh Frozen Plasma | Active comparator | Biological: Fresh Frozen PlasmaAdministration of a single dose of fresh frozen plasma of 15 mL/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with spontaneous intracranial hemorrhage or traumatic intracranial hemorrhage or patient requiring neurological surgery
- Coagulation disorder defined by PT less than 60%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prothrombin Complex ConcentrateNon-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S | Drug | Prothrombin Complex Concentrate |
| Fresh Frozen PlasmaPooled collection of plasma from donors | Biological | Fresh Frozen Plasma |
Primary outcome
Proportion of patients with correction of prothrombin time (PT more than 60%)
Time frame: End of treatment administration (an average of 1 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Derived from this study: PubMed 37870112Eilertsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prothrombin Complex Concentrate and Fresh Frozen Plasma in people with Intracranial Hemorrhages, run by Fondation Ophtalmologique Adolphe de Rothschild at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with correction of prothrombin time (PT more than 60%) (time frame: End of treatment administration (an average of 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02777424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.