Caffeinol Hypothermia Protocol

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Caffeinol

hypothermia

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Stroke, Nonhemorrhagic, hypothermia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-80 years Clinical presentation of acute ischemic stroke Computed tomography (CT) scan compatible with acute ischemic stroke. Time to caffeinol treatment < 240 minutes from stroke onset. Time to hypothermia initiation < 300 minutes from stroke onset. Presumed cortical location of stroke (must have at least on sign such as aphasia, neglect, visual field cut) National Institutes of Health Stroke Scale (NIHSS) > 8 at time of each treatment. Tissue plasminogen activator (TPA) treated patients must meet all established criteria for TPA. Exclusion Criteria: Etiology other than ischemic stroke. Item 1a on NIHSS > 1 Signs/symptoms of subcortical, brainstem or cerebellar stroke. Symptoms resolving or NIHSS < 8 at time of each treatment. NIHSS > 20 if right hemisphere or >25 if left hemisphere Known alcoholic Clinical or laboratory evidence of alcohol intoxication. Historical evidence of exogenous caffeine exposure beyond daily consumption of coffee or soft drinks. Known hematologic dyscrasias that affect thrombosis. Comorbid conditions likely to complicate therapy: End-stage cardiomyopathy Uncompensated or clinically significant arrhythmia Myopathy Liver disease History of pelvic or abdominal mass likely to compress inferior vena cava. End-stage AIDS History of clinically significant gastrointestinal (GI) bleeding Impaired renal function with creatinine clearance, 50 ml/min Intracerebral / intraventricular hemorrhage Systolic blood pressure (SBP) > 210 or < 100; diastolic blood pressure (DBP) > 100 or < 50 mmHg Severe coagulopathy Pregnancy Use of monoamine oxidase inhibitor (MAOI),serotonin-specific reuptake inhibitor (SSRI) or Tricyclic Antidepressants (TCA) within the preceding 2 weeks Known history of epilepsy.

Sites / Locations

Memorial Hermann Hospital - Medical Center

Outcomes

Primary Outcome Measures

Number of Participants With Symptomatic Intracerebral Hemorrhage

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

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

The possibility of cardiorespiratory failure was monitored every 30 minutes during the 24 hour hypothermia period based on vitals signs and oxygen saturation.

Secondary Outcome Measures

Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming,

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.

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.

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.

Full Information

NCT ID

NCT00299416

First Posted

March 2, 2006

Last Updated

April 5, 2011

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT00299416

Brief Title

Caffeinol Hypothermia Protocol

Official Title

Combined Neuroprotective Modalities Coupled With Thrombolysis in Acute Ischemic Stroke: A Pilot Study of Caffeinol and Mild Hypothermia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

February 2003 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Caffeinol is a combination of caffeine and alcohol. The amount given is about the same as 1-2 glasses of wine and 3-4 cups of coffee. The patient receives a one time dose given over two hour while being cooled to 34.5 C.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

Keywords

Stroke, Nonhemorrhagic, hypothermia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Caffeinol

Intervention Description

Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours.

Intervention Type

Procedure

Intervention Name(s)

hypothermia

Intervention Description

External or internal cooling for 24 hours and rewarming over 12 hours.

Primary Outcome Measure Information:

Title

Number of Participants With Symptomatic Intracerebral Hemorrhage

Description

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)

Time Frame

from pre-dosage to 90 day followup

Title

Number of Participants With Catheter Related Complications During Hypothermia & Rewarming

Description

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.

Time Frame

over 36 hour period

Title

Number of Participants With Cardiorespiratory Failure

Description

The possibility of cardiorespiratory failure was monitored every 30 minutes during the 24 hour hypothermia period based on vitals signs and oxygen saturation.

Time Frame

every 30 minutes during hypothermia induction

Secondary Outcome Measure Information:

Title

Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming,

Description

Hypothermia will be maintained for 24 hours, afterward, the patient will be rewarmed, gradually, over 12 hours to 36.5C.

Time Frame

rewarming over 12 hours until 36.5C has been achieved

Title

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

Title

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.

Description

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.

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Age 18-80 years Clinical presentation of acute ischemic stroke Computed tomography (CT) scan compatible with acute ischemic stroke. Time to caffeinol treatment < 240 minutes from stroke onset. Time to hypothermia initiation < 300 minutes from stroke onset. Presumed cortical location of stroke (must have at least on sign such as aphasia, neglect, visual field cut) National Institutes of Health Stroke Scale (NIHSS) > 8 at time of each treatment. Tissue plasminogen activator (TPA) treated patients must meet all established criteria for TPA. Exclusion Criteria: Etiology other than ischemic stroke. Item 1a on NIHSS > 1 Signs/symptoms of subcortical, brainstem or cerebellar stroke. Symptoms resolving or NIHSS < 8 at time of each treatment. NIHSS > 20 if right hemisphere or >25 if left hemisphere Known alcoholic Clinical or laboratory evidence of alcohol intoxication. Historical evidence of exogenous caffeine exposure beyond daily consumption of coffee or soft drinks. Known hematologic dyscrasias that affect thrombosis. Comorbid conditions likely to complicate therapy: End-stage cardiomyopathy Uncompensated or clinically significant arrhythmia Myopathy Liver disease History of pelvic or abdominal mass likely to compress inferior vena cava. End-stage AIDS History of clinically significant gastrointestinal (GI) bleeding Impaired renal function with creatinine clearance, 50 ml/min Intracerebral / intraventricular hemorrhage Systolic blood pressure (SBP) > 210 or < 100; diastolic blood pressure (DBP) > 100 or < 50 mmHg Severe coagulopathy Pregnancy Use of monoamine oxidase inhibitor (MAOI),serotonin-specific reuptake inhibitor (SSRI) or Tricyclic Antidepressants (TCA) within the preceding 2 weeks Known history of epilepsy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James C. Grotta, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Hermann Hospital - Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.houstonstroke.com

Description

Introduction of the staff and facility on the stroke team, types of strokes, treatment, risk factors, recovery clinical trials, and contact information.

Acute Ischemic Stroke

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial