Intracerebral HemorrhageEarly Phase 1SNICHNCT02078037
Systemic Normothermia in Intracerebral Hemorrhage (ICH)
A Early Phase 1 study testing Arctic Sun cooling device in people with Intracerebral Hemorrhage, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care group. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Arctic Sun cooling device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Apr 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with spontaneous supratentorial ICH >20 cc
- Age 18 to 85 years of age
- Consent from the patient or surrogate decision maker
- Within 24 hours of onset of ictus
Who cannot join
- Hemorrhage secondary to trauma, Arterio-venous malformation (AVM), aneurysm or Arterio-venous dural fistula
- Moribund state and deemed unlikely to survive until study completion (5 days)
- Patients with a don-not-resuscitate (DNR) order
- Known infection at the time of admission (elevated white blood cell count (WBC) with identified infection source).
- Evidence of a blood dyscrasia
- Pregnancy
Show all 11Show fewer
- Renal failure (CCR < 50 ml/min)
- Contraindications for a brain MRI scan
- Infratentorial ICH
- Warfarin-induced intracerebral hemorrhages NOT corrected to International Normalized Ratio (INR) < 1.4 within 24 hours
- Episode of fever > 38.5 degrees Celsius prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care group. The investigators propose to test the hypothesis that prophylactic forced normothermia in patients with ICH leads to less systemic inflammation and decreased perihematomal edema.
Read the detailed description
This is a randomized device efficacy trial. Patients with a supratentorial intracerebral hemorrhage (ICH) admitted to the Cleveland Clinic Neurointensive Care Unit within 1 day of symptom onset and who have not experienced episodes of temperature elevation will be enrolled after consent. Patients randomized to the experimental arm, will have Artic Sun cooling pads applied to the torso and thighs for five days. The Arctic Sun device will keep the body temperature at the normal range of 35.5 - 37.5 degrees Celsius. Patients randomized to the active comparator arm will receive a standard of care treatment at the discretion of the treating physician. Patients will have hourly measurement of blood pressure, heart rate, respiratory rate, urine output, temperature (from the urinary catheter) shivering scale, and nursing neurological assessment. Glasgow coma scale, NIH Stroke Scale Score (NIHSS), telemetry monitoring and labs will also be performed daily. The investigators will also collect demographic information about the patients (i.e. age, gender, medical risk factors) and information regarding their current disease process.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Arctic Sun cooling device, Standard of Care
- Keywords
- Intracerebral hemorrhage, Perihematomal edema, hemorrhage, normothermia
- Medical subject headings
- Cerebral Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arctic Sun cooling deviceDevice
Also called The Arctic Sun® 5000 Temperature management systems
The Arctic Sun® 5000 Temperature management systems (Bard Medical), a non- invasive, surface cooling technology that allows rapid and precise manipulation of core body temperature will be employed to maintain normothermia (normal temperature) in patients with ICH randomized to the treatment group.
Standard of CareOther
Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician)
| Study group | Role | What they receive |
|---|---|---|
| Arctic Sun cooling device | Experimental | The Arctic Sun device pads will be placed on the patient as per manufacturer's instructions. Patients, who cannot tolerate placement of all the pads for any given reason, will still be included in the study if they can maintain normothermia (normal body temperature). The total normothermia time for the study is five days. After 5 days, the attending physician will make clinical decisions based on the patient needs.The temperature goal for this study is 36.5 degree Celsius, but normothermia for the purpose of this study will be defined as a temperature of 35.5 - 37.5 degree Celsius. A thermometer mounted urinary catheter will be used for temperature monitoring and feedback to the Arctic Sun. Receives: Device: Arctic Sun cooling device |
| Standard of Care | Active comparator | Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician) initiated at a temperature of 38.5 degrees Celsius Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI measurement of relative perihematomal edema (% change of perihematomal edema)
Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI
Measured: First 5 days of hospital course
Secondary outcomes (2)
Structured telephone interview of functional and cognitive outcome
Functional and cognitive outcomes measured by structured phone assessment.
Measured: 3 months and 1 year
Serum cytokine measurement with inflammatory cytokine protein array
Cytokine markers of inflammation tested daily over the first 5 days.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier J Provencio, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078037
- Sponsor's protocol ID
- 13-1407
- Acronym
- SNICH
- Status last verified
- Jan 2017
- First submitted
- 21 Feb 2014
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Normothermia in Intracerebral Hemorrhage (ICH)
- ClinicalTrials.gov ID
- NCT02078037
- Acronym / sponsor ID
- SNICH / 13-1407
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral hemorrhage, Perihematomal edema, hemorrhage, normothermia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care group. The investigators propose to test the hypothesis that prophylactic forced normothermia in patients with ICH leads to less systemic inflammation and decreased perihematomal edema.
Detailed description
This is a randomized device efficacy trial. Patients with a supratentorial intracerebral hemorrhage (ICH) admitted to the Cleveland Clinic Neurointensive Care Unit within 1 day of symptom onset and who have not experienced episodes of temperature elevation will be enrolled after consent. Patients randomized to the experimental arm, will have Artic Sun cooling pads applied to the torso and thighs for five days. The Arctic Sun device will keep the body temperature at the normal range of 35.5 - 37.5 degrees Celsius. Patients randomized to the active comparator arm will receive a standard of care treatment at the discretion of the treating physician. Patients will have hourly measurement of blood pressure, heart rate, respiratory rate, urine output, temperature (from the urinary catheter) shivering scale, and nursing neurological assessment. Glasgow coma scale, NIH Stroke Scale Score (NIHSS), telemetry monitoring and labs will also be performed daily. The investigators will also collect demographic information about the patients (i.e. age, gender, medical risk factors) and information regarding their current disease process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arctic Sun cooling device | Experimental | Device: Arctic Sun cooling deviceThe Arctic Sun device pads will be placed on the patient as per manufacturer's instructions. Patients, who cannot tolerate placement of all the pads for any given reason, will still be included in the study if they can maintain normothermia (normal body temperature). The total normothermia time for the study is five days. After 5 days, the attending physician will make clinical decisions based on the patient needs.The temperature goal for this study is 36.5 degree Celsius, but normothermia for the purpose of this study will be defined as a temperature of 35.5 - 37.5 degree Celsius. A thermometer mounted urinary catheter will be used for temperature monitoring and feedback to the Arctic Sun. |
| Standard of Care | Active comparator | Other: Standard of CarePatient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician) initiated at a temperature of 38.5 degrees Celsius |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with spontaneous supratentorial ICH >20 cc
- Age 18 to 85 years of age
- Consent from the patient or surrogate decision maker
- Within 24 hours of onset of ictus
Key exclusion criteria (11 listed)
- Hemorrhage secondary to trauma, Arterio-venous malformation (AVM), aneurysm or Arterio-venous dural fistula
- Moribund state and deemed unlikely to survive until study completion (5 days)
- Patients with a don-not-resuscitate (DNR) order
- Known infection at the time of admission (elevated white blood cell count (WBC) with identified infection source).
- Evidence of a blood dyscrasia
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 |
|---|---|---|
| Arctic Sun cooling deviceAlso: The Arctic Sun® 5000 Temperature management systemsThe Arctic Sun® 5000 Temperature management systems (Bard Medical), a non- invasive, surface cooling technology that allows rapid and precise manipulation of core body temperature will be employed to maintain normothermia (normal temperature) in patients with ICH randomized to the treatment group. | Device | Arctic Sun cooling device |
| Standard of CarePatient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician) | Other | Standard of Care |
Primary outcome
MRI measurement of relative perihematomal edema (% change of perihematomal edema)
Time frame: First 5 days of hospital course
Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI
2 secondary outcomes
Structured telephone interview of functional and cognitive outcome
Time frame: 3 months and 1 year
Serum cytokine measurement with inflammatory cytokine protein array
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Javier J Provencio, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Arctic Sun cooling device in people with Intracerebral Hemorrhage, run by The Cleveland Clinic 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 4 inclusion and 11 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 10 Jan 2017. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MRI measurement of relative perihematomal edema (% change of perihematomal edema) (time frame: First 5 days of hospital course). 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 10 Jan 2017.