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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 202
- 试验地点
- 21
- 主要终点
- Percentage of intracranial bleeding diagnosed in CT scan
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
研究组 & 干预措施
Actual recommendations
Current guidelines recommend to perform a CT scan and realise the anticoagulation reversion only in case of intracranial bleeding diagnosed.
干预措施: Reversion (Drug)
Preventive reversion
Realise a preventive reversion before performing any CT scan.
干预措施: Reversion (Drug)
结局指标
主要结局
Percentage of intracranial bleeding diagnosed in CT scan
时间窗: 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.
次要结局
- Percentage of patient having a decrease in their autonomy(3 months)
- Percentage of patient having a systemic or neurologic ischemic attacks(1 month)
- Volumetric measure of intracranial haemorrhage(CT scan performed 24 hours +/-4 after inclusion)