Trial Outcomes & Findings for Reperfusion With Cooling in Cerebral Acute Ischemia (NCT NCT01585597)

NCT ID: NCT01585597

Last Updated: 2014-08-01

Results Overview

Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying \>30% of the infarct zone with mass effect

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 20 participants
• Primary outcome timeframe: 24 Hours
• Results posted on: 2014-08-01

Participant Flow

Participant milestones

Measure	Mild Hypothermia Reduction of body temperature to 34 degrees centigrade. Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reperfusion With Cooling in Cerebral Acute Ischemia

Baseline characteristics by cohort

Measure	Mild Hypothermia n=20 Participants Reduction of body temperature to 34 degrees centigrade. Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.
Age, Continuous	59 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Hours

Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying >30% of the infarct zone with mass effect

Outcome measures

Measure	Mild Hypothermia n=20 Participants Reduction of body temperature to 34 degrees centigrade. Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.
Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation	3 participants

SECONDARY outcome

Timeframe: 90 days post hospitalization

Modified Rankin Score 0=no symptoms

1. no significant disability

2. slight disability needs help

3. moderate disability

4. moderate serve disability

5. severe disability 0-2 = good outcome 3-5= poor outcome

Outcome measures

Measure	Mild Hypothermia n=20 Participants Reduction of body temperature to 34 degrees centigrade. Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.
Modified Rankin Scale 0-2	20 participants Modified Rankin Scal 0-2

Adverse Events

Mild Hypothermia

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mild Hypothermia n=20 participants at risk Reduction of body temperature to 34 degrees centigrade. Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.
Infections and infestations Pneumonia	25.0% 5/20 • Number of events 5 • 90 days
Infections and infestations Bacteremia	5.0% 1/20 • Number of events 1 • 90 days
Blood and lymphatic system disorders Deep Venous Thrombosis	5.0% 1/20 • Number of events 1 • 90 days
Infections and infestations Urinary Tract Infection	20.0% 4/20 • Number of events 4 • 90 days

Other adverse events

Adverse event data not reported

Additional Information

Christopher Horn

Emory University

Phone: 404 387 7320

Email: cmhorn@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place