Coagulation; IntravascularPhase 3PREVACTNCT01961804
PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma
A Phase 3 study testing Reversion in people with Coagulation; Intravascular and Craniocerebral Trauma, run by University Hospital, Angers at 21 sites in France.
Trial summary
The occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist treatment leads to a high risk of bleeding. Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to reverse anticoagulation with concomitant administration of prothrombin complex concentrates… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation; Intravascular, Craniocerebral Trauma, Haemorrhage
- What is being tested?
- Reversion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 21 sitesFrance
- Study dates
- Mar 2014to 3 Sep 2020
- Phase
- Phase 3
- 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
- Admission in an emergency departement for a recent and isolated minor head trauma with at least one of the following characteristic : a period of alteration in the level of consciousness, a period of loss of consciousness (< 30 min), a posttraumatic amnesia, persistant posttraumatic headache, repeated vomitting (at least 2 episodes) or any other neurological sign such a convulsion or a localised neurological sign, wound of the scalp or the face testifying of the importance of the cranial trauma...
- Subject receiving anticoagulant treatment with anti-vitamin K for the treatment of atrial fibrillation (AF)
- Initial ED Glasgow Coma Scale (GCS) score of ≥13
- Achievable follow up
- Informed consent form signed by the patient or if he/she isn't able an emergency inclusion can be realised.
Who cannot join
- Delay between the minor head trauma and the possible preventive PCC's administration > 6h
- Subject receiving anticoagulant treatment other than anti vitamin K (heparin, fondaparinux, dabigatran, rivaroxaban, apixaban...)
- Subject receiving anticoagulant treatment for other reason than a AF
- Subject on antiplatelet treatment (except the use of low dose of aspirin (≤ 100 mg/day)
- Delocalised biology INR in capillary blood < 1.5 if it's available (only in departement where this analyse is a usual practice)
- Haemorrhage or suspected haemorrhage other than intracranial which could led to a reversion of the anticoagulation
Show all 11Show fewer
- Head trauma associated with one or further potential haemorrhagic traumatic lesions
- Subject who reject the use of products derived from human blood
- Women who are pregnant
- Subject with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
- Subject without social security registered
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
CH Agen
Agen
CHU Angers
Angers, 49933
Ch Annecy
Annecy
CHU Chateauroux
Châteauroux
CHU Clermont Ferrand
Clermont-Ferrand
CHG du Mans
Le Mans
Ch Les Sables D'Olonne
Les Sables-d'Olonne
Ch Longjumeau
Longjumeau
HCL Edouard Herriot
Lyon
CHU METZ
Metz
Chg Montauban
Montauban
Chu Nantes
Nantes
CHU Nice
Nice
CHU Pitié Salpétrière
Paris
Chu Tenon
Paris
Chu Poitiers
Poitiers
Chu Saint Brieuc
Saint-Brieuc
Ch Saint Malo
St-Malo
Chu Toulouse
Toulouse
Chu Tours
Tours
Ch Versailles
Versailles
About this study
Official title: Phase 3 Study Comparing Preventive Reversal of Vitamine K Antagonist Versus Reversion Only in Case of Intracranial Bleeding in Patients Receiving Vitamine K Antagonist Treatment
The occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist treatment leads to a high risk of bleeding.
Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to reverse anticoagulation with concomitant administration of prothrombin complex concentrates (PCCs) and vitamin K.
Read more
However, even if a reversion is performed, the prognostic of post-traumatic intracranial bleeding remain bad.
The investigators hypothesize that, for patients admitted in an emergency department after a minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion with PCCs can lead to a significant reduction of intracranial haemorrhage and can also improve the neurological prognostic of patients versus the current strategy.
PREVACT will test this hypothesis, in an open label, randomized, multicentre, clinical trial involving 400 patients.
- Being tested
- Reversion
- Medical subject headings
- Thrombosis, Craniocerebral Trauma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReversionDrug
Also called KANOKAD
Administration of prothrombin complex concentrates: KANOKAD before CT Scan
| Study group | Role | What they receive |
|---|---|---|
| Actual recommendations | Other | Current guidelines recommend to perform a CT scan and realise the anticoagulation reversion only in case of intracranial bleeding diagnosed. Receives: Drug: Reversion |
| Preventive reversion | Experimental | Realise a preventive reversion before performing any CT scan. Receives: Drug: Reversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of intracranial bleeding diagnosed in CT scan
This primary outcome measure will be analyse in a centralised place by two neuro-radiologist in blind of the randomised group.
Measured: 24 hours +/- 4 hours
Secondary outcomes (3)
Volumetric measure of intracranial haemorrhage
This secondary outcome measure will be analyse in a centralised place by two neuro-radiologist in blind of the randomised group.
Measured: CT scan performed 24 hours +/-4 after inclusion
Percentage of patient having a decrease in their autonomy
A loss of at least one point in the Glasgow Outcome Score Extended
Measured: 3 months
Percentage of patient having a systemic or neurologic ischemic attacks
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startMar 2014
- Primary completion28 Feb 2020
- Study completion3 Sep 2020
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 Coagulation; IntravascularStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- ROY Pierre-Marie, Professor, Principal investigator, UH AngersTAZAROURTE Karim, Pr, Study chair, UH Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961804
- Sponsor's protocol ID
- PHRC 2012-02
- Acronym
- PREVACT
- Status last verified
- Aug 2020
- First submitted
- 9 Oct 2013
- Last updated
- 27 Apr 2021
- Results posted
- No
Publications
Douillet D, Tazarourte K, Dehours E, Brice C, Andrianjafy H, Trinh-Duc A, Lasocki S, Labriffe M, Riou J, Roy PM. Systematic vitamin K antagonist reversal with prothrombin complex concentrate in patients with mild traumatic brain injury: randomized controlled trial. Eur J Emerg Med. 2025 Jun 1;32(3):180-187. doi: 10.1097/MEJ.0000000000001199. Epub 2024 Nov 6.
PubMed 40315031
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study Comparing Preventive Reversal of Vitamine K Antagonist Versus Reversion Only in Case of Intracranial Bleeding in Patients Receiving Vitamine K Antagonist Treatment
- ClinicalTrials.gov ID
- NCT01961804
- Acronym / sponsor ID
- PREVACT / PHRC 2012-02
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Mar 2014 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 11 Oct 2013 (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.
The occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist treatment leads to a high risk of bleeding.
Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to reverse anticoagulation with concomitant administration of prothrombin complex concentrates (PCCs) and vitamin K.
However, even if a reversion is performed, the prognostic of post-traumatic intracranial bleeding remain bad.
The investigators hypothesize that, for patients admitted in an emergency department after a minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion with PCCs can lead to a significant reduction of intracranial haemorrhage and can also improve the neurological prognostic of patients versus the current strategy.
PREVACT will test this hypothesis, in an open label, randomized, multicentre, clinical trial involving 400 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actual recommendations | Other | Drug: ReversionCurrent guidelines recommend to perform a CT scan and realise the anticoagulation reversion only in case of intracranial bleeding diagnosed. |
| Preventive reversion | Experimental | Drug: ReversionRealise a preventive reversion before performing any CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admission in an emergency departement for a recent and isolated minor head trauma with at least one of the following characteristic : a period of alteration in the level of consciousness, a period of loss of consciousness (< 30 min), a posttraumatic amnesia, persistant posttraumatic headache, repeated vomitting (at least 2 episodes) or any other neurological sign such a convulsion or a localised neurological sign, wound of the scalp or the face testifying of the importance of the cranial trauma...
- Subject receiving anticoagulant treatment with anti-vitamin K for the treatment of atrial fibrillation (AF)
- Initial ED Glasgow Coma Scale (GCS) score of ≥13
- Achievable follow up
- Informed consent form signed by the patient or if he/she isn't able an emergency inclusion can be realised.
Key exclusion criteria (11 listed)
- Delay between the minor head trauma and the possible preventive PCC's administration > 6h
- Subject receiving anticoagulant treatment other than anti vitamin K (heparin, fondaparinux, dabigatran, rivaroxaban, apixaban...)
- Subject receiving anticoagulant treatment for other reason than a AF
- Subject on antiplatelet treatment (except the use of low dose of aspirin (≤ 100 mg/day)
- Delocalised biology INR in capillary blood < 1.5 if it's available (only in departement where this analyse is a usual practice)
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 |
|---|---|---|
| ReversionAlso: KANOKADAdministration of prothrombin complex concentrates: KANOKAD before CT Scan | Drug | Actual recommendations, Preventive reversion |
Primary outcome
Percentage of intracranial bleeding diagnosed in CT scan
Time frame: 24 hours +/- 4 hours
This primary outcome measure will be analyse in a centralised place by two neuro-radiologist in blind of the randomised group.
3 secondary outcomes
Volumetric measure of intracranial haemorrhage
Time frame: CT scan performed 24 hours +/-4 after inclusion
Percentage of patient having a decrease in their autonomy
Time frame: 3 months
Percentage of patient having a systemic or neurologic ischemic attacks
Time frame: 1 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 40315031Douillet D, Tazarourte K, Dehours E, Brice C, Andrianjafy H, Trinh-Duc A, Lasocki S, Labriffe M, Riou J, Roy PM. Systematic vitamin K antagonist reversal with prothrombin complex concentrate in patients with mild traumatic brain injury: randomized controlled trial. Eur J Emerg Med. 2025 Jun 1;32(3):180-187. doi: 10.1097/MEJ.0000000000001199. Epub 2024 Nov 6.
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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.
ROY Pierre-Marie, Professor principal investigator
UH Angers
TAZAROURTE Karim, Pr study chair
UH Lyon
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reversion in people with Coagulation; Intravascular and Craniocerebral Trauma, run by University Hospital, Angers at 21 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
Percentage of intracranial bleeding diagnosed in CT scan (time frame: 24 hours +/- 4 hours). 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 NCT01961804, 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 27 Apr 2021.