Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 81
- 主要终点
- Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis
研究概览
简要总结
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80
- •Symptom onset less than 24 hrs prior to diagnostic CT scan
- •Spontaneous ICH less than or equal to 30 cc or primary IVH
- •IVH obstructing 3rd and/or 4th ventricles
- •ICH clot stability at 6 hours or more post IVC placement
- •IVH clot stability at 6 hours or more post IVC placement
- •Catheter tract bleeding stability 6 hours or more post IVC placement
- •EVD placed per standard medical care
- •SBP less than 200 mmHg sustained for 6 hours prior to drug administration
- •Able to randomize within 72 hours of diagnostic CT scan
- •Historical Rankin of 0 or 1
排除标准
- •Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor
- •Presence of a choroid plexus vascular malformation or Moyamoya
- •Clotting disorders
- •Platelet count less than 100,000, INR greater than 1.4
- •Pregnancy
- •Infratentorial hemorrhage
- •SAH at clinical presentation
- •ICH/IVH enlargement that cannot be stabilized in the treatment time window
- •Ongoing internal bleeding
- •Superficial or surface bleeding
- •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
- •Planned or simultaneous participation (between screening and Day-30) in another interventional medical investigation or clinical trial.
- •No subject or legal representative to give written informed consent
研究组 & 干预措施
Alteplase
administration of alteplase via the intraventricular catheter
干预措施: Alteplase (Drug)
Saline Placebo
1 ml of normal saline administered via the intraventricular catheter
干预措施: Normal saline (Other)
结局指标
主要结局
Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis
时间窗: 180 days
Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis
时间窗: 180 days
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis
时间窗: 180 days
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3
时间窗: 180 days
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3
时间窗: 30 days and 180 days
Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
次要结局
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female)(180 days)
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male)(180 days)
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic)(180 days)
- All Cause Mortality(180 days)
- Clot Removal (Amount of Residual Blood)(72 hours)
- Intensity of Critical Care Management - Hospital Days(30 days)
- Intensity of Critical Care Management - ICU Days(30 days)
- Intensity of Critical Care Management - ICP Management(30 days)
- Intensity of Critical Care Management - Mechanical Ventilation(30 days)
- Intensity of Critical Care Management - Pressors(30 days)
- Intensity of Critical Care Management - Shunts(30 days)
- Intensity of Critical Care Management - All Infections(180 days)
- Intensity of Critical Care Management - Pneumonia(30 days)
- Safety/Mortality - Mortality Within 30 Days(30 days)
- Safety/Mortality - Bacterial Brain Infections Within 30 Days(30 days)
- Safety/Mortality - Systematic Bleeds Within 72 Hours(72 hours)
- Safety/Mortality - Systematic Bleeds Within 30 Days(30 days)
- Adverse and Serious Adverse Events(180 days)
- Predicting Hazards of Death by Treatment Group(180 days)
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White)(180 days)
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American)(180 days)
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years)(180 days)
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml)(180 days)
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under)(180 days)
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml)(180 days)
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml)(180 days)
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic)(180 days)
- Quality of Life - Stroke Impact Scale (SIS) - Thinking(180 days)
- Quality of Life - Stroke Impact Scale (SIS) - Emotion(180 days)
- Quality of Life - Stroke Impact Scale (SIS) - Participation(180 days)
- Quality of Life - Stroke Impact Scale (SIS) - Recovery(180 days)
- Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS)(180 days)
- Functional Status - Barthel Index(180 days)
- Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability(180 days)
- Functional Status - National Institutes of Health Stroke Scale (NIHSS)(180 days)
- Quality of Life - Stroke Impact Scale (SIS) - Strength(180 days)
- Quality of Life - Stroke Impact Scale (SIS) - Mobility(180 days)
- Quality of Life - Stroke Impact Scale (SIS) - Hand Function(180 days)
- Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living(180 days)
- Quality of Life - Stroke Impact Scale (SIS) - Communication(180 days)