Caffeinol Hypothermia Protocol
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|ClinicalTrials.gov Identifier: NCT00299416|
Recruitment Status : Completed
First Posted : March 6, 2006
Results First Posted : May 3, 2011
Last Update Posted : May 3, 2011
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke||Drug: Caffeinol Procedure: hypothermia||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Neuroprotective Modalities Coupled With Thrombolysis in Acute Ischemic Stroke: A Pilot Study of Caffeinol and Mild Hypothermia|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||August 2009|
- Number of Participants With Symptomatic Intracerebral Hemorrhage [ Time Frame: from pre-dosage to 90 day followup ]Symptomatic intracerebral hemorrhages were measured by a full NIHSS(National Institute of Health Stroke Scale) prior to caffeinol & hypothermia,at the end of hypothermia & rewarming, 24 hrs after stroke onset, daily during hospitalization,& at the 90 day follow-up visit. In addition, modified NIHSS were done hourly during the 24 hr hypothermia period & 12 hr rewarming period. At the end of rewarming an MRI was obtained to verify if hemorrhages or neurologic deteriorations were present.NIHSS scores severity of stroke on 11 items;more points given for greater deficiencies(range 0-42,0=normal)
- Number of Participants With Catheter Related Complications During Hypothermia & Rewarming [ Time Frame: over 36 hour period ]Catheter-related complications assessed whether participants had bleeding (major hemorrhaging) that required a blood transfusion, this was determined by labs. Participants were monitored for infections every hour during vital signs in the 24 hour hypothermia phase and 12 hour rewarming phase.
- Number of Participants With Cardiorespiratory Failure [ Time Frame: every 30 minutes during hypothermia induction ]The possibility of cardiorespiratory failure was monitored every 30 minutes during the 24 hour hypothermia period based on vitals signs and oxygen saturation.
- Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming, [ Time Frame: rewarming over 12 hours until 36.5C has been achieved ]Hypothermia will be maintained for 24 hours, afterward, the patient will be rewarmed, gradually, over 12 hours to 36.5C.
- Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering. [ Time Frame: rewarming over 12 hours until 36.5C has been achieved ]
- Efficacy: NIHSS < 2 at 24 Hours, Modified Rankin Scale (mRS) < 2 at 3 Months, NIHSS < 2 at 3 Months, and Length of Hospital and ICU Stay. [ Time Frame: 90 days ]NIHSS score of ≤ 2 24 hours after stroke onset modified Rankin Scale (mRS) < 2 at 90 day followup NIHSS score of ≤ 2 at daily duration of hospitalization and ICU stay and 90 day follow up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299416
|United States, Texas|
|Memorial Hermann Hospital - Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||James C. Grotta, MD||The University of Texas Health Science Center, Houston|