Acute Ischemic StrokePhase 1/2NCT00299416
Caffeinol Hypothermia Protocol
A Phase 1/2 study testing Caffeinol and hypothermia in people with Acute Ischemic Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Caffeinol and hypothermia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Aug 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Hospital - Medical Center
Houston, Texas, 77030
About this study
Official title: Combined Neuroprotective Modalities Coupled With Thrombolysis in Acute Ischemic Stroke: A Pilot Study of Caffeinol and Mild Hypothermia
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Caffeinol, hypothermia
- Keywords
- Stroke, Nonhemorrhagic, hypothermia
- Medical subject headings
- Ischemic Stroke, Stroke, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeinolDrug
Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours.
hypothermiaProcedure or surgery
External or internal cooling for 24 hours and rewarming over 12 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: every 30 minutes during hypothermia induction
Secondary outcomes (3)
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.
Measured: rewarming over 12 hours until 36.5C has been achieved
Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startFeb 2003
- Primary completionJan 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Investigators
- James C. Grotta, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299416
- Sponsor's protocol ID
- HSC- MS-02-188
- Other IDs
- P50NS44277 project #1
- Status last verified
- Apr 2011
- First submitted
- 2 Mar 2006
- Last updated
- 3 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Neuroprotective Modalities Coupled With Thrombolysis in Acute Ischemic Stroke: A Pilot Study of Caffeinol and Mild Hypothermia
- ClinicalTrials.gov ID
- NCT00299416
- Acronym / sponsor ID
- HSC- MS-02-188
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Nonhemorrhagic, hypothermia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 6 Mar 2006 (estimated)
- Results
- Posted 3 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaffeinolInfusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours. | Drug | – |
| hypothermiaExternal or internal cooling for 24 hours and rewarming over 12 hours. | Procedure or surgery | – |
Primary outcome
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.
3 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C. Grotta, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Caffeinol and hypothermia in people with Acute Ischemic Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Symptomatic Intracerebral Hemorrhage (time frame: from pre-dosage to 90 day followup). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2011.