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Preconditioning for Aneurismal Subarachnoid Hemorrhage

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sebastian Koch, University of Miami
ClinicalTrials.gov Identifier:
NCT01110239
First received: April 21, 2010
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
Results First Received: August 9, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Subarachnoid Hemorrhage
Intervention: Procedure: remote limb preconditioning

  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
Subjects admitted to a large community based teaching hospital were recruited between November 2008 and July 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
none

Reporting Groups
  Description
Sham Preconditioning Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes. A sham preconditioning group was added with only minimal cuff inflation.
5-min Ischemia No text entered.
7.5-min Ischemia No text entered.
10-min Ischemia No text entered.

Participant Flow for 4 periods

 Period 1:   Sham Preconditioning
    Sham Preconditioning     5-min Ischemia     7.5-min Ischemia     10-min Ischemia  
STARTED     7     14     7     6  
COMPLETED     7     14     6     6  
NOT COMPLETED     0     0     1     0  
Withdrawal by Subject                 0                 0                 1                 0  

Period 2:   5 Min Ischemia
    Sham Preconditioning     5-min Ischemia     7.5-min Ischemia     10-min Ischemia  
STARTED     0     14     0     0  
COMPLETED     0     0     0     0  
NOT COMPLETED     0     14     0     0  

Period 3:   7.5 Min Ischemia
    Sham Preconditioning     5-min Ischemia     7.5-min Ischemia     10-min Ischemia  
STARTED     0     0     7     0  
COMPLETED     0     0     6     0  
NOT COMPLETED     0     0     1     0  
Withdrawal by Subject                 0                 0                 1                 0  

Period 4:   10 Min Ischemia
    Sham Preconditioning     5-min Ischemia     7.5-min Ischemia     10-min Ischemia  
STARTED     0     0     0     6  
COMPLETED     0     0     0     6  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Sham Preconditioning Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
5 Min Ischemia No text entered.
7.5 Min Ischemia No text entered.
10 Min Ischemia No text entered.
Total Total of all reporting groups

Baseline Measures
    Sham Preconditioning     5 Min Ischemia     7.5 Min Ischemia     10 Min Ischemia     Total  
Number of Participants  
[units: participants]
 		  7     14     7     6     34  
Age  
[units: years]
Mean ± Standard Deviation 		  49  ± 9     53  ± 14     47  ± 12     62  ± 10     52  ± 12  
Gender  
[units: participants]
 		         
Female     6     9     4     3     22  
Male     1     5     3     3     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Deep Vein Thrombosis for Safety Assessment.   [ Time Frame: 90 days ]
  Show Outcome Measure 1

2.  Primary:   Visual Analog Scale Score as a Measure of Tolerability   [ Time Frame: 90 days ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Sebastian Koch
Organization: University Miami
phone: 305 243-6733
e-mail: skoch@med.miami.edu


No publications provided


Responsible Party: Sebastian Koch, University of Miami
ClinicalTrials.gov Identifier: NCT01110239     History of Changes
Other Study ID Numbers: 20080406
Study First Received: April 21, 2010
Results First Received: August 9, 2011
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board