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Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00784134
First Posted: November 3, 2008
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Genentech, Inc.
Emissary International LLC
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: March 30, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Intraventricular Hemorrhage
Interventions: Drug: Alteplase
Other: Normal saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Alteplase

Administration of alteplase via the intraventricular catheter

Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses

Saline Placebo

1 ml of normal saline administered via the intraventricular catheter

Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses


Participant Flow:   Overall Study
    Alteplase   Saline Placebo
STARTED   249   251 
COMPLETED   246   245 
NOT COMPLETED   3   6 
Lost to Follow-up                3                6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Alteplase

Administration of alteplase via the intraventricular catheter

Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses

Saline Placebo

1 ml of normal saline administered via the intraventricular catheter

Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses

Total Total of all reporting groups

Baseline Measures
   Alteplase   Saline Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 249   251   500 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      182  73.1%      172  68.5%      354  70.8% 
>=65 years      67  26.9%      79  31.5%      146  29.2% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      105  42.2%      117  46.6%      222  44.4% 
Male      144  57.8%      134  53.4%      278  55.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      1   0.4%      1   0.2% 
Asian      7   2.8%      7   2.8%      14   2.8% 
Native Hawaiian or Other Pacific Islander      3   1.2%      1   0.4%      4   0.8% 
Black or African American      92  36.9%      78  31.1%      170  34.0% 
White      144  57.8%      161  64.1%      305  61.0% 
More than one race      0   0.0%      1   0.4%      1   0.2% 
Unknown or Not Reported      3   1.2%      2   0.8%      5   1.0% 
Region of Enrollment 
[Units: Participants]
     
Canada   3   6   9 
Hungary   7   6   13 
United States   190   180   370 
Brazil   1   3   4 
United Kingdom   4   4   8 
Israel   13   24   37 
Switzerland   1   3   4 
Germany   21   18   39 
Spain   9   7   16 


  Outcome Measures
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1.  Primary:   Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis   [ Time Frame: 180 days ]

2.  Primary:   Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis   [ Time Frame: 180 days ]

3.  Primary:   Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis   [ Time Frame: 180 days ]

4.  Primary:   Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3   [ Time Frame: 180 days ]

5.  Primary:   Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3   [ Time Frame: 30 days and 180 days ]

6.  Secondary:   All Cause Mortality   [ Time Frame: 180 days ]

7.  Secondary:   Clot Removal (Amount of Residual Blood)   [ Time Frame: 72 hours ]

8.  Secondary:   Intensity of Critical Care Management - Hospital Days   [ Time Frame: 30 days ]

9.  Secondary:   Intensity of Critical Care Management - ICU Days   [ Time Frame: 30 days ]

10.  Secondary:   Intensity of Critical Care Management - ICP Management   [ Time Frame: 30 days ]

11.  Secondary:   Intensity of Critical Care Management - Mechanical Ventilation   [ Time Frame: 30 days ]

12.  Secondary:   Intensity of Critical Care Management - Pressors   [ Time Frame: 30 days ]

13.  Secondary:   Intensity of Critical Care Management - Shunts   [ Time Frame: 30 days ]

14.  Secondary:   Intensity of Critical Care Management - All Infections   [ Time Frame: 30 days ]

15.  Secondary:   Intensity of Critical Care Management - Pneumonia   [ Time Frame: 30 days ]

16.  Secondary:   Intensity of Critical Care Management - All Infections   [ Time Frame: 180 days ]

17.  Secondary:   Safety/Mortality - Mortality Within 30 Days   [ Time Frame: 30 days ]

18.  Secondary:   Safety/Mortality - Bacterial Brain Infections Within 30 Days   [ Time Frame: 30 days ]

19.  Secondary:   Safety/Mortality - Systematic Bleeds Within 72 Hours   [ Time Frame: 72 hours ]

20.  Secondary:   Safety/Mortality - Systematic Bleeds Within 30 Days   [ Time Frame: 30 days ]

21.  Secondary:   Adverse and Serious Adverse Events   [ Time Frame: 180 days ]

22.  Secondary:   Predicting Hazards of Death by Treatment Group   [ Time Frame: 180 days ]

23.  Secondary:   Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American)   [ Time Frame: 180 days ]

24.  Secondary:   Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White)   [ Time Frame: 180 days ]

25.  Secondary:   Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female)   [ Time Frame: 180 days ]

26.  Secondary:   Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male)   [ Time Frame: 180 days ]

27.  Secondary:   Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under)   [ Time Frame: 180 days ]

28.  Secondary:   Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years)   [ Time Frame: 180 days ]

29.  Secondary:   Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml)   [ Time Frame: 180 days ]

30.  Secondary:   Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml)   [ Time Frame: 180 days ]

31.  Secondary:   Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml)   [ Time Frame: 180 days ]

32.  Secondary:   Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic)   [ Time Frame: 180 days ]

33.  Secondary:   Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic)   [ Time Frame: 180 days ]

34.  Secondary:   Functional Status - Barthel Index   [ Time Frame: 180 days ]

35.  Secondary:   Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability   [ Time Frame: 180 days ]

36.  Secondary:   Functional Status - National Institutes of Health Stroke Scale (NIHSS)   [ Time Frame: 180 days ]

37.  Secondary:   Quality of Life - Stroke Impact Scale (SIS) - Strength   [ Time Frame: 180 days ]

38.  Secondary:   Quality of Life - Stroke Impact Scale (SIS) - Mobility   [ Time Frame: 180 days ]

39.  Secondary:   Quality of Life - Stroke Impact Scale (SIS) - Hand Function   [ Time Frame: 180 days ]

40.  Secondary:   Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living   [ Time Frame: 180 days ]

41.  Secondary:   Quality of Life - Stroke Impact Scale (SIS) - Communication   [ Time Frame: 180 days ]

42.  Secondary:   Quality of Life - Stroke Impact Scale (SIS) - Thinking   [ Time Frame: 180 days ]

43.  Secondary:   Quality of Life - Stroke Impact Scale (SIS) - Emotion   [ Time Frame: 180 days ]

44.  Secondary:   Quality of Life - Stroke Impact Scale (SIS) - Participation   [ Time Frame: 180 days ]

45.  Secondary:   Quality of Life - Stroke Impact Scale (SIS) - Recovery   [ Time Frame: 180 days ]

46.  Secondary:   Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS)   [ Time Frame: 180 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Daniel F. Hanley
Organization: Johns Hopkins University Division of Brain Injury Outcomes
phone: 4106146996
e-mail: dhanley@jhmi.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00784134     History of Changes
Other Study ID Numbers: IVH06
5U01NS062851-05 ( U.S. NIH Grant/Contract )
First Submitted: October 31, 2008
First Posted: November 3, 2008
Results First Submitted: March 30, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017