Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 25
- 主要终点
- 30-day Mortality
研究概览
简要总结
The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.
详细描述
The purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses. Results of this stage (n=16) were then analyzed and the most effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the optimal frequency of dosing. We propose to test if this intervention facilitates more rapid clot resolution, complete recovery function and decreased mortality from this condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IVC placed as standard of care using less than or equal to 2 complete passes.
- •Spontaneous ICH less than or equal to 30 cc.
- •Able to receive first dose within 48 hours of CT scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours).
- •Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size plus or minus 5 cc (as determined by the AxBxC)/2 method).
- •ON stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of CSF flow on CT).
- •SBP < 200 mmHg sustained for 6 hours.
- •Historical Rankin of 0 or 1.
排除标准
- •Suspected or untreated aneurysm or AVM (unless ruled out by angiogram or MRA/MRI).
- •Clotting disorders.
- •Patients with platelet count < 100,000, INR > 1.7, PT > 15s, or an elevated APTT.
- •Pregnancy (positive pregnancy test).
- •Infratentorial hemorrhage (i.e., parenchymal/posterior fossa hematoma; all cerebellar hematomas excluded).
- •SAH (An angiogram should be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. If the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study).
- •ICH enlargement during the 6-hour stabilization period (6 hour after IVC placement).
- •Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.
- •Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention.
- •Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis.
- •Prior enrollment in the study.
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- •Participation in another simultaneous medical investigation or trial.
研究组 & 干预措施
0.3 mg rt-PA
In stage 1 of the protocol, dose finding, subjects were randomized to either this 0.3 mg dose arm or the 1.0 mg dose arm. Subjects in this arm (0.3 mg) received up to 8 doses of 0.3 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage.
干预措施: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo) (Drug)
1.0 mg rt-PA
In stage 1 of the protocol, dose finding, subjects were randomized to either this 1.0 mg dose arm or the 0.3 mg dose arm. Subjects in this arm (1.0 mg) received up to 8 doses of 1.0 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage.
干预措施: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo) (Drug)
1.0 mg Rt-PA q8h
In stage 2 of the protocol, dose frequency, subjects received up to 8 doses of 1.0 mg of rt-PA (Cathflo) every 8 hours through the intraventricular catheter to treat intraventricular hemorrhage.
干预措施: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo) (Drug)
结局指标
主要结局
30-day Mortality
时间窗: 30 days
The number of subjects who died at or before the 30-day follow-up visit were determined as a measure of safety. If more than 50% of the subjects died at or before the 30-day follow-up visit, the study would have been stopped for full DSMB review.
Rate of Symptomatic Bleeding Events
时间窗: 30-days
The rate of symptomatic brain bleeding events were recorded to determine the safety of intraventricular administrations of rt-PA. If 35% or more subjects experienced a symptomatic bleeding event prior to the 30-day follow-up visit, the study would have been stopped for a full DSMB review.
Incidence of Bacterial Ventriculitis, Meningitis
时间窗: 30 days
The incidence of bacterial ventriculitis/meningitis was recorded to determine the safety of intraventricular administration of rt-PA. If 30% or more subjects experienced this event, the study would have been stopped for full DSMB review.
次要结局
- Average Daily Percentage Clot Size Resolution Over the First 3 Days(3 days)
- 90 Day Follow-Up Glasgow Outcome Scale (GOS) Score(90 days)
- 90 Day Follow-Up Modified Rankin Scale (mRS) Score(90 days)
- 180 Day Follow-Up Modified Rankin Scale (mRS) Score(180 days)
- 180 Day Follow-Up Glasgow Outcome Scale (GOS) Score(180 days)