Cardiac ArrestPhase 4COOLNCT00843297
COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest
A Phase 4 study testing Coolgard, ArcticSun and Conventional treatment in people with Cardiac Arrest and Hypothermia, run by University of Leipzig at 1 site in Germany.
Trial summary
Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Arrest, Hypothermia
- What is being tested?
- Coolgard, ArcticSun and Conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Jan 2010
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ROSC after SCA due to VF/VT or PEA/Asystolia
- GCS 3
Who cannot join
- Non-cardiac SCA
- Pregnancy
- Unstable Circulation instead of High-dose Inotropics
- Life-expectancy reducing concomitant illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Neurological Outcome With Two Different Cooling Methods (Invasive and Non-invasive) After Sudden Cardiac Arrest
Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.
Read the detailed description
Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC). Blood samples of neuron-specific enolase (NSE) were collected during 72 hours.
- Conditions
- Cardiac Arrest, Hypothermia
- Being tested
- Coolgard, ArcticSun, Conventional treatment
- Keywords
- Sudden Cardiac Arrest, Hypothermia, Outcome, neurological, Coolgard, ArcticSun
- Medical subject headings
- Heart Arrest, Hypothermia, Death, Sudden, Cardiac, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolgardDevice
invasive Cooling via femoral ICY-catheter
ArcticSunDevice
Noninvasive surface-cooling by saline-cooled thermo-vest
Conventional treatmentOther
Intensive care-treatment without cooling
| Study group | Role | What they receive |
|---|---|---|
| CG | Active comparator | Coolgard: invasive Cooling Receives: Device: Coolgard |
| AS | Active comparator | ArcticSun: Surface-Cooling Receives: Device: ArcticSun |
| UnCOOL | Sham comparator | No Cooling-Therapy due to non-operational cooling-devices Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach the target temperature
Measured: Twenty-four hours
NSE as a parameter for cerebral damage
Measured: Seventy-two hours
Secondary outcomes (3)
Neurologic outcome
Measured: Six months
Survival
Measured: Six months
Periprocedural complications
Measured: Seventy-two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startApr 2008
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Investigators
- Holger Thiele, Associate Professor, Principal investigator, Study ChairUndine Pittl, MD, Study director, Study Sub-Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843297
- Sponsor's protocol ID
- COOL-Trial
- Acronym
- COOL
- Status last verified
- Jan 2010
- First submitted
- 12 Feb 2009
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Zeiner A, Holzer M, Sterz F, Behringer W, Schorkhuber W, Mullner M, Frass M, Siostrzonek P, Ratheiser K, Kaff A, Laggner AN. Mild resuscitative hypothermia to improve neurological outcome after cardiac arrest. A clinical feasibility trial. Hypothermia After Cardiac Arrest (HACA) Study Group. Stroke. 2000 Jan;31(1):86-94. doi: 10.1161/01.str.31.1.86.
PubMed 10625721Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
PubMed 11856794
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Neurological Outcome With Two Different Cooling Methods (Invasive and Non-invasive) After Sudden Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00843297
- Acronym / sponsor ID
- COOL / COOL-Trial
- Conditions
- Cardiac Arrest, Hypothermia
- Keywords
- Sudden Cardiac Arrest, Hypothermia, Outcome, neurological, Coolgard, ArcticSun
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Feb 2009 (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.
Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.
Detailed description
Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC). Blood samples of neuron-specific enolase (NSE) were collected during 72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CG | Active comparator | Device: CoolgardCoolgard: invasive Cooling |
| AS | Active comparator | Device: ArcticSunArcticSun: Surface-Cooling |
| UnCOOL | Sham comparator | Other: Conventional treatmentNo Cooling-Therapy due to non-operational cooling-devices |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ROSC after SCA due to VF/VT or PEA/Asystolia
- GCS 3
Key exclusion criteria (4 listed)
- Non-cardiac SCA
- Pregnancy
- Unstable Circulation instead of High-dose Inotropics
- Life-expectancy reducing concomitant illness
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 |
|---|---|---|
| Coolgardinvasive Cooling via femoral ICY-catheter | Device | CG |
| ArcticSunNoninvasive surface-cooling by saline-cooled thermo-vest | Device | AS |
| Conventional treatmentIntensive care-treatment without cooling | Other | UnCOOL |
Primary outcome
Time to reach the target temperature
Time frame: Twenty-four hours
NSE as a parameter for cerebral damage
Time frame: Seventy-two hours
3 secondary outcomes
Neurologic outcome
Time frame: Six months
Survival
Time frame: Six months
Periprocedural complications
Time frame: Seventy-two hours
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 2 Feb 2010.
- Background: PubMed 10625721Zeiner A, Holzer M, Sterz F, Behringer W, Schorkhuber W, Mullner M, Frass M, Siostrzonek P, Ratheiser K, Kaff A, Laggner AN. Mild resuscitative hypothermia to improve neurological outcome after cardiac arrest. A clinical feasibility trial. Hypothermia After Cardiac Arrest (HACA) Study Group. Stroke. 2000 Jan;31(1):86-94. doi: 10.1161/01.str.31.1.86.
- Background: PubMed 11856794Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
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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.
Holger Thiele, Associate Professor principal investigator
Study Chair
Undine Pittl, MD study director
Study Sub-Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coolgard, ArcticSun and Conventional treatment in people with Cardiac Arrest and Hypothermia, run by University of Leipzig at 1 site in Germany.
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 2 inclusion and 4 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 2 Feb 2010. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Time to reach the target temperature (time frame: Twenty-four hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00843297, which also lists 2 linked publications.
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 2 Feb 2010.