Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P50NS44277 project #1 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeinol | Drug | Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours. | ||
| hypothermia | Procedure | External or internal cooling for 24 hours and rewarming over 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | from pre-dosage to 90 day followup |
| 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. | over 36 hour period |
| 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. | every 30 minutes during hypothermia induction |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | rewarming over 12 hours until 36.5C has been achieved |
Not provided
Inclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James C. Grotta, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital - Medical Center | Houston | Texas | 77030 | United States |
Open label pilot trial; Caffeinol Arm
Patient/& or family was approached by one of the investigators in the Emergency Department in order to obtain informed consent.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Caffeinol | Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Caffeinol | Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 were determined by intention to treat. We did not use any imputation technique. | Posted | Number | participants | from pre-dosage to 90 day followup |
|
Adverse event data was collected over the duration of the study (2003-2009)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caffeinol | Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Nervous system disorders | Systematic Assessment | Three patients died (SAE unrelated to study interventions): (1) symptomatic hemorrhage due to severity of stroke (1) malignant edema/ herniation (1) unrelated medical condition (withdrawal of care requested by family) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Surgical and medical procedures | Systematic Assessment | Sedation noted:
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James C. Grotta, MD | UT-Houston Health Science Center, Department of Neurology | 713-500-7088 | james.c.grotta@uth.tmc.edu |
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C503306 | caffeinol |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering. |
| 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. | 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. | 90 days |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Not Posted | Number | participants with acute ischemic stroke | rewarming over 12 hours until 36.5C has been achieved |
| Secondary | Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering. | Not Posted | Number | participants with acute ischemic stroke | rewarming over 12 hours until 36.5C has been achieved |
| Secondary | 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. | Not Posted | Number | participants with acute ischemic stroke | 90 days |
| Primary | 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. | Posted | Number | participants | over 36 hour period |
|
|
|
| Primary | 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. | Posted | Number | participants | every 30 minutes during hypothermia induction |
|
|
|
| 9 |
| 30 |
| 17 |
| 30 |
|
| Neuroworsening | Nervous system disorders | Systematic Assessment |
|
| Cholecysitits | Hepatobiliary disorders | Systematic Assessment |
|
| Reduced respiratory drive | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Parenchymal hemorrhage | Nervous system disorders | Systematic Assessment | 3 symptomatic 1 asymptomatic |
|
| Thrombotic thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment | Attributed to clopidrogrel and required treatment with plasmapheresis |
|
|
| Elevated CK | Cardiac disorders | Systematic Assessment | Elevated Ck noted -asymptomatic/ resolved |
|
| Elevated Amylase | Gastrointestinal disorders | Systematic Assessment | Elevated amylase noted:Asymptomatic/resolved. |
|
| Device failure | Surgical and medical procedures | Systematic Assessment | Cooling machine failure (3) Icy catheter tubing leak (1) |
|
| Asymptomatic hemorrhagic transformation | Nervous system disorders | Systematic Assessment | Noted/ resolved |
|
| Elevated WBC | Blood and lymphatic system disorders | Systematic Assessment | No fever/ symptoms; resolved without treatment. |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | (1)Treated with lasix and nebulizer treatment. Resolved. (1)Shortness of breath, oxygen saturation 87%, infiltrates on CXR. Treated with BiPAP & lasix |
|
| Infection | Infections and infestations | Systematic Assessment |
|
|
| Low Hgb/ Hct | Blood and lymphatic system disorders | Systematic Assessment |
|
| Abnormal Labs (chem.) | Blood and lymphatic system disorders | Systematic Assessment | (1)Low K+ - replaced/ resolved (1)Elevated K+ - treated (1)Elevated Mg - asymptomatic/ resolved |
|
| Arrhythmia | Cardiac disorders | Systematic Assessment | (1) A. fib (1)A. fib with AV block |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |