Caffeinol Hypothermia Protocol
|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|
|Primary Completion Date :||January 2009|
|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.
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|