Management of Seizures after Traumatic brain injury
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,649
- 试验地点
- 1
- 主要终点
- MAST-DURATION: the occurrence of late post-traumatic seizure.
研究概览
简要总结
Brief Study Protocol
Post-traumatic seizures (PTS) are a common complication of traumatic brain injury (TBI), affecting up to ~15 % of closed TBIs. PTS may impair brain metabolism with potentially severe consequences on patients’ neurological outcomes and a significant impact on healthcare costs. The evidence supporting the use of antiepileptic drugs (AEDs) for the management of PTS remains very low, with consequent ambiguity in the latest guidelines for TBI management. In this context, MAST Prophylaxis was developed to address the issue of preventing PTS.
The MAST trial is already registered with EudraCT Number: 2020-000282-16 and
ISRCTN Number: ISRCTN13200656
The study is funded by the NIHR HTA Programme and it is sponsored by the University of Cambridge.
Due to longstanding collaboration and shared research interest with the Neurosurgical Department at NIMHANS, the latter Institute will launch an equivalent study in India. The study will mirror the ongoing UK trial.
| Purpose of clinical trial |
To assess
1. Anti-epileptic drug (AED) prophylaxis following traumatic brain injury (TBI) (MAST-PROPHYLAXIS)
2. Duration of AED treatment following post- traumatic seizure(s) (PTS) (MAST- DURATION)
This will be assessed by conducting 2 parallel but independent trials. Eligibility to enter either trial
will be dependent on whether an early seizure has occurred.
|Trial Design
MAST-PROPHYLAXIS: Phase 3, randomised multi-centre, pragmatic, parallel group trial.
MAST-DURATION: Phase 3, randomised multicentre, pragmatic, parallel group trial
Both studies will start with an internal pilot study.
|Trial Outcome Measures
Primary outcome measure:
· MAST-PROPHYLAXIS: Occurrence of PTS within 2 weeks after TBI.
· MAST-DURATION: Occurrence of late PTS within 24 months after TBI.
Secondary outcome measures:
· PTS up to 2 years (MAST-PROPHYLAXIS only)
· Extended Glasgow Outcome Scale, Neurobehavioural Symptom Inventory, quality of life (EQ-5D-5L), and Liverpool Adverse Events Profile at 6, 12, 18 and 24 months.
· Economic evaluation
· Frequency of PTS
· Mortality at 6, 12, 18 and 24 months.
· Adverse events of special interest during treatment.
|Sample Size
Recruitment of:
MAST-PROPHYLAXIS: 1221 participants in total (130 in an internal pilot)
MAST-DURATION: 428 participants in total (50 in an internal pilot)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Male
入选标准
- •MAST DURATION Inclusion Criteria: Patients aged ≥10 years with TBI managed in an NSU who have started on an phenytoin or levetiracetam due to an acute symptomatic seizure during acute hospitalisation Patient or Legal Representative is willing and able to provide informed consent or in the absence of a legal representative, an Independent Healthcare Professional provides authorisation for patient enrolment MAST PROPHYLAXIS Inclusion Criteria: Patients aged ≥10 years, with TBI managed in an NSU without an acute symptomatic seizure Patient or Legal Representative is willing and able to provide informed consent or in the absence of a legal representative, an Independent Healthcare Professional provides authorisation for patient enrolment within 48 hours of admittance.
排除标准
- •MAST DURATION Unsurvivable injury Previous history of epilepsy Patients who are on an AED pre-TBI Patient who has been clinically prescribed an AED other than phenytoin or levetiracetam Unwillingness to take products containing gelatin (animal products) Severe lactose intolerance or any known hypersensitivity to study drug or any of its excipients MAST PROPHYLAXIS Post-traumatic seizures Unsurvivable injury Previous history of epilepsy Patients who are on an AED pre-TBI Pregnancy or breastfeeding Unwillingness to take products containing gelatin (animal products) Severe lactose intolerance or any known hypersensitivity to study drug or any of its excipients Time interval from the time of admission to NSU to randomisation exceeds 48 hours.
结局指标
主要结局
MAST-DURATION: the occurrence of late post-traumatic seizure.
时间窗: MAST-DURATION: Within 24 months post traumatic brain injury | MAST-PROPHYLAXIS: Occurrence of post-traumatic seizures within 2 weeks post TBI
MAST-PROPHYLAXIS: is the occurrence of an acute symptomatic seizure.
时间窗: MAST-DURATION: Within 24 months post traumatic brain injury | MAST-PROPHYLAXIS: Occurrence of post-traumatic seizures within 2 weeks post TBI
次要结局
- • Extended Glasgow Outcome Scale, Neurobehavioural Symptom Inventory, quality of life (EQ-5D-5L), and Liverpool Adverse Events(At 6, 12, 18 and 24 months)
- THe frequency of post traumatic seizures(Within 24 months post traumatic brain injury)
- Mortality(Death from any cause)
- Frequency of adverse events of special interest (unfavourable and unintended sign, symptom, or disease temporally associated with the use of trial drug, whether or not considered related to the trial drug.(Up to 24 months)
研究者
Dhaval Shukla
National Institute of Mental Health and Neurosciences, Bengaluru