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The Intravascular Cooling in the Treatment of Stroke 2/3 Trial (ICTuS2/3)

This study has been terminated.
(The ICTuS 2 portion of the trial has been halted and data will be analyzed.)
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Patrick Lyden, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01123161
First received: April 27, 2010
Last updated: February 18, 2017
Last verified: February 2017
Results First Received: September 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Outcomes Assessor;   Primary Purpose: Treatment
Condition: Stroke, Acute
Interventions: Device: hypothermia and anti-shivering treatment
Drug: Group1: IV t-PA and normothermia

  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
No text entered.

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
Group1: IV t-PA and Normothermia

IV tpa and normothermia

Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia

Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment

IV tpa and hypothermia and anti-shivering treatment

hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming.


Participant Flow:   Overall Study
    Group1: IV t-PA and Normothermia   Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment
STARTED   57   63 
COMPLETED   55   63 
NOT COMPLETED   2   0 
Lost to Follow-up                1                0 
Withdrawal by Subject                1                0 



  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.
Patients enrolled and randomized

Reporting Groups
  Description
Group1: IV t-PA and Normothermia

IV tpa and normothermia

Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia

Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment

IV tpa and hypothermia and anti-shivering treatment

hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming

Total Total of all reporting groups

Baseline Measures
   Group1: IV t-PA and Normothermia   Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   63   120 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.5  (11.1)   65.5  (10.3)   66.4  (10.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      22  38.6%      29  46.0%      51  42.5% 
Male      35  61.4%      34  54.0%      69  57.5% 
Baseline NIHSS [1] 
[Units: Points]
Mean (Standard Deviation)
 14.5  (4.9)   14.1  (4.8)   14.3  (4.8) 
[1] The NIHSS measures neurological deficit. Scores range from 0 (best) to 42 (worst). Between 0 and 42 higher scores reflect progressively worse neurological deficit.
Baseline temperature 
[Units: Degrees (C)]
Mean (Standard Deviation)
 36.4  (0.50)   36.6  (0.46)   36.5  (0.48) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Primary Outcome is the Proportion of Patients Achieving a Favorable Outcome Defined as Modified Rankin Scale Score of 0 or 1, Assessed 90 Days After Treatment.   [ Time Frame: 90 days ]

2.  Primary:   Incidence of Any Intracranial Hemorrhage (ICH) Within 48 Hours of Stroke Onset   [ Time Frame: 48 hours ]

3.  Primary:   Incidence of Any Symptomatic Intracranial Hemorrhage (sICH) Within 48 Hours of Stroke Onset   [ Time Frame: 48 hours ]

4.  Primary:   Incidence of Pneumonia   [ Time Frame: 7 days or discharge whichever comes first ]

5.  Primary:   90 Day Mortality   [ Time Frame: 90 days ]

6.  Secondary:   The Barthel Index Measure of Activities of Daily Living;   [ Time Frame: 90 days ]

7.  Secondary:   NIHSS Scores at 90 Days   [ Time Frame: 90 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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Patrick Lyden
Organization: Cedars-Sinai Medical Center
phone: 310-423-5166
e-mail: lydenp@cshs.org


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

Responsible Party: Patrick Lyden, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01123161     History of Changes
Other Study ID Numbers: ICTuS2/3
P50NS044148 ( U.S. NIH Grant/Contract )
P50NS044227 ( U.S. NIH Grant/Contract )
Study First Received: April 27, 2010
Results First Received: September 29, 2016
Last Updated: February 18, 2017