Postcardiac ArrestNCT02033720
Study of Survivors of Different Types of Cardiac Arrest and Their Neurological Recovery
An observational study of Postcardiac Arrest and Pulseless Electrical Activity, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
After successful resuscitation from certain types of cardiac arrest, total body cooling is now a well established treatment that improves the chances of the brain recovering. This however, has only been definitively proven after a certain type of cardiac arrest that is "ventricular fibrillation / ventricular… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postcardiac Arrest, Pulseless Electrical Activity, Asystole
- What is being tested?
- No treatment and Therapeutic hypothermia
- How many people
- 400 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2014to Feb 2015
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the intensive care unit (ICU) with a diagnosis of postcardiac arrest between Jan 2008 and Dec 2012 will be examined.
Who may be able to join
- Admission to adult ICU (age ≥18 years) at London Health Sciences Centre
- Primary reason for ICU admission: postcardiac arrest
- Both in-hospital and out-of-hospital cardiac arrest will be included
- ICU admission between Jan 2008 and Dec 2012.
Who cannot join
- ICU admissions primarily for reasons other than cardiac arrest.
Trial locations and contacts
2 sites in 1 country.
Eyad AlThenayan, MD contact
Canada2 sites
University Hospital, London Health Sciences Centre, University of Western Ontario
London, Ontario, N6A 5A5
Ahmed F Hegazy, MD, FRCPC, 1(519) 860-4917, ahmed.hegazy@londonhospitals.ca
Eyad Althenayan, MD, 1 (519) 685-8500 ext. 19119, eyad.althenayan@lhsc.on.ca
Victoria Hospital, London Health Sciences Centre, University of Western Ontario
London, Ontario, N6A 5W9
Ahmed F Hegazy, MD, FRCPC, 1(519) 860-4917, ahmed.hegazy@londonhospitals.ca
Eyad Althenayan, MD, 1 (519) 685-8500 ext. 19119, eyad.althenayan@lhsc.on.ca
About this study
Official title: Neurological Outcomes After Cardiac Arrest in Pulseless Electrical Activity in Comparison to Asystole. Are All Non-shockable Rhythms the Same?
After successful resuscitation from certain types of cardiac arrest, total body cooling is now a well established treatment that improves the chances of the brain recovering. This however, has only been definitively proven after a certain type of cardiac arrest that is "ventricular fibrillation / ventricular tachycardia". The purpose of this study is to explore if total body cooling is beneficial for patients recovering from another type of cardiac arrest that is "pulseless electrical activity".
HYPOTHESIS:
Patients undergoing post-cardiac arrest therapeutic hypothermia have better neurological outcomes if their initial arrest rhythm is pulseless electrical activity (PEA) in comparison to asystole.
Read the detailed description
STUDY RATIONALE AND BACKGROUND INFORMATION:
After successful resuscitation from cardiac arrest the body experiences a period of global reperfusion. During this period, patients may show signs of myocardial stunning, lactic acidosis, neurological injury and reperfusion syndrome. This constellation of findings constitutes what is known as post-cardiac arrest syndrome. The brain appears to be one of the most vulnerable organs to injury during this reperfusion phase and varying degrees of cognitive impairment may be the end result. Inducing mild therapeutic hypothermia has been shown to be protective for the brain in this setting and has been demonstrated to improve neurological recovery. The evidence for this however, is only conclusive in cases where the arrest is in a shockable rhythm i.e. pulseless ventricular tachycardia and ventricular fibrillation.
In 2002, two randomized controlled trials were published showing an improvement in neurological outcomes in patients treated with mild therapeutic hypothermia post resuscitation from shockable cardiac arrest. Therapeutic hypothermia has since been widely adopted by most authorities as part of the comprehensive treatment bundle for post cardiac arrest syndrome. Whether there is any benefit for patients arrested in non-shockable rhythms however, is a matter of controversy. Some have reported improved mortality and better neurological outcomes with therapeutic hypothermia in this patient population. Others have reported no benefit or even a trend towards harm. And although the matter remains controversial, the recommendation still stands for therapeutic hypothermia to be offered for all comatose survivors of cardiac arrest whatever the arrest rhythm.
Most previous reports have examined the differences between shockable and non-shockable rhythms in terms of neurological outcome and mortality rates after therapeutic hypothermia. To our knowledge, no study has examined the differences in outcome between the two types of non-shockable rhythms, that is pulseless electrical activity (PEA) and asystole. We hypothesize that during PEA arrests, patients may retain some degree of cerebral perfusion and hence have better neurological outcomes post-resuscitation. That is in contrast to asystole where patients are likely to have no cerebral perfusion. In this study we attempt to detect any possible differences in neurological recovery (as indicated by the Cerebral Performance Category scale on hospital discharge) after therapeutic hypothermia, between patients arrested in PEA arrest and those arrested in asystole.
- Conditions
- Postcardiac Arrest, Pulseless Electrical Activity, Asystole
- Being tested
- No treatment, Therapeutic hypothermia
- Keywords
- postcardiac arrest, post cardiac arrest syndrome, post cardiac arrest hypothermia, pulseless electrical activity, asystole, therapeutic hypothermia, therapeutic hypothermia after cardiac arrest, therapeutic hypothermia neurologic outcome
- Medical subject headings
- Heart Arrest, Post-Cardiac Arrest Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatmentOther
Also called No therapeutic hypothermia., Control.
No therapeutic hypothermia was induced.
Therapeutic hypothermiaOther
Also called Hypothermia, Induced hypothermia, Mild therapeutic hypothermia, Cooling
Hypothermia was induced after successful resuscitation from cardiac arrest.
| Study group | Role | What they receive |
|---|---|---|
| Shockable arrest | Initial arrest rhythm shockable. This is either pulseless ventricular tachycardia (pulseless VT) or ventricular fibrillation (VF). Receives: Other: No treatment; Other: Therapeutic hypothermia | |
| Pulseless electrical activity | Initial arrest rhythm is pulseless electrical activity. Receives: Other: No treatment; Other: Therapeutic hypothermia | |
| Asystole | Initial arrest rhythm is asystole. Receives: Other: No treatment; Other: Therapeutic hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral performance category score on hospital discharge
Neurological outcome on discharge from hospital as defined by the cerebral performance category (CPC) scale. The CPC scale is a 5 point scale. The outcome measure will be dichotomized into good or bad. Good outcome will be equivalent to CPC scores of 1 \& 2 (where the patient is independent), and bad outcome will be equivalent to CPC scores of 3, 4 \& 5 (where the patient is either dependent or dead).
CPC Scale:
- Functioning normally and independent, possibly with a minor disability.
- Moderately disabled, still independent.
- Conscious but with a severe disability, dependent.
- Unconscious (comatose or in a persistent vegetative state).
- Brain dead or dead by traditional criteria.
Measured: Upon discharge from hospital, assessed up to 36 months postcardiac arrest
Secondary outcomes (3)
Hospital length of stay postcardiac arrest
Hospital length of stay (LOS) post-cardiac arrest will be calculated from the day of the cardiac arrest to the day of hospital discharge. If prior to the arrest the patient was an inpatient, we will only count the days from the arrest to discharge. Days spent in hospital prior to the arrest will not be included.
Measured: Days spent in hospital after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest
Intensive care unit length of stay postcardiac arrest
The length of stay (LOS) in the intensive care unit (ICU) in days, after successful resuscitation from cardiac arrest.
Measured: Days spent in the intensive care unit after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest
Neurological status after hospital discharge
Neurological status as documented on the patient's first outpatient clinic visit, assessed up to 12 months from hospital discharge. This will be analyzed as a secondary outcome only if enough data is generated on chart review.
Measured: Assessed up to 12 months from hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postcardiac ArrestStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Principal investigator, Eyad AlThenayan, University of Western Ontario, Canada
- Investigators
- Eyad Althenayan, MD, Principal investigator, Western University, CanadaPhilip Jones, MD, FRCPC, Study director, Western University, CanadaBryan Young, MD, FRCPC, Study chair, Western University, CanadaAhmed F Hegazy, MD, FRCPC, Study director, Western University, CanadaAna Igric, MD, FRCSC, Study director, Western University, CanadaCarolyn Benson, MD, Study director, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033720
- Sponsor's protocol ID
- 104666
- Status last verified
- Jan 2014
- First submitted
- 4 Jan 2014
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Holzer M. Targeted temperature management for comatose survivors of cardiac arrest. N Engl J Med. 2010 Sep 23;363(13):1256-64. doi: 10.1056/NEJMct1002402. No abstract available.
PubMed 20860507Bernard 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 11856794Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.
PubMed 11856793Hazinski MF, Nolan JP, Billi JE, Bottiger BW, Bossaert L, de Caen AR, Deakin CD, Drajer S, Eigel B, Hickey RW, Jacobs I, Kleinman ME, Kloeck W, Koster RW, Lim SH, Mancini ME, Montgomery WH, Morley PT, Morrison LJ, Nadkarni VM, O'Connor RE, Okada K, Perlman JM, Sayre MR, Shuster M, Soar J, Sunde K, Travers AH, Wyllie J, Zideman D. Part 1: Executive summary: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S250-75. doi: 10.1161/CIRCULATIONAHA.110.970897. No abstract available.
PubMed 20956249Arrich J; European Resuscitation Council Hypothermia After Cardiac Arrest Registry Study Group. Clinical application of mild therapeutic hypothermia after cardiac arrest. Crit Care Med. 2007 Apr;35(4):1041-7. doi: 10.1097/01.CCM.0000259383.48324.35.
PubMed 17334257Testori C, Sterz F, Behringer W, Haugk M, Uray T, Zeiner A, Janata A, Arrich J, Holzer M, Losert H. Mild therapeutic hypothermia is associated with favourable outcome in patients after cardiac arrest with non-shockable rhythms. Resuscitation. 2011 Sep;82(9):1162-7. doi: 10.1016/j.resuscitation.2011.05.022. Epub 2011 Jun 12.
PubMed 21705132Dumas F, Grimaldi D, Zuber B, Fichet J, Charpentier J, Pene F, Vivien B, Varenne O, Carli P, Jouven X, Empana JP, Cariou A. Is hypothermia after cardiac arrest effective in both shockable and nonshockable patients?: insights from a large registry. Circulation. 2011 Mar 1;123(8):877-86. doi: 10.1161/CIRCULATIONAHA.110.987347. Epub 2011 Feb 14.
PubMed 21321156
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Outcomes After Cardiac Arrest in Pulseless Electrical Activity in Comparison to Asystole. Are All Non-shockable Rhythms the Same?
- ClinicalTrials.gov ID
- NCT02033720
- Acronym / sponsor ID
- 104666
- Conditions
- Postcardiac Arrest, Pulseless Electrical Activity, Asystole
- Keywords
- postcardiac arrest, post cardiac arrest syndrome, post cardiac arrest hypothermia, pulseless electrical activity, asystole, therapeutic hypothermia, therapeutic hypothermia after cardiac arrest, therapeutic hypothermia neurologic outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 13 Jan 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.
After successful resuscitation from certain types of cardiac arrest, total body cooling is now a well established treatment that improves the chances of the brain recovering. This however, has only been definitively proven after a certain type of cardiac arrest that is "ventricular fibrillation / ventricular tachycardia". The purpose of this study is to explore if total body cooling is beneficial for patients recovering from another type of cardiac arrest that is "pulseless electrical activity".
HYPOTHESIS:
Patients undergoing post-cardiac arrest therapeutic hypothermia have better neurological outcomes if their initial arrest rhythm is pulseless electrical activity (PEA) in comparison to asystole.
Detailed description
STUDY RATIONALE AND BACKGROUND INFORMATION:
After successful resuscitation from cardiac arrest the body experiences a period of global reperfusion. During this period, patients may show signs of myocardial stunning, lactic acidosis, neurological injury and reperfusion syndrome. This constellation of findings constitutes what is known as post-cardiac arrest syndrome. The brain appears to be one of the most vulnerable organs to injury during this reperfusion phase and varying degrees of cognitive impairment may be the end result. Inducing mild therapeutic hypothermia has been shown to be protective for the brain in this setting and has been demonstrated to improve neurological recovery. The evidence for this however, is only conclusive in cases where the arrest is in a shockable rhythm i.e. pulseless ventricular tachycardia and ventricular fibrillation.
In 2002, two randomized controlled trials were published showing an improvement in neurological outcomes in patients treated with mild therapeutic hypothermia post resuscitation from shockable cardiac arrest. Therapeutic hypothermia has since been widely adopted by most authorities as part of the comprehensive treatment bundle for post cardiac arrest syndrome. Whether there is any benefit for patients arrested in non-shockable rhythms however, is a matter of controversy. Some have reported improved mortality and better neurological outcomes with therapeutic hypothermia in this patient population. Others have reported no benefit or even a trend towards harm. And although the matter remains controversial, the recommendation still stands for therapeutic hypothermia to be offered for all comatose survivors of cardiac arrest whatever the arrest rhythm.
Most previous reports have examined the differences between shockable and non-shockable rhythms in terms of neurological outcome and mortality rates after therapeutic hypothermia. To our knowledge, no study has examined the differences in outcome between the two types of non-shockable rhythms, that is pulseless electrical activity (PEA) and asystole. We hypothesize that during PEA arrests, patients may retain some degree of cerebral perfusion and hence have better neurological outcomes post-resuscitation. That is in contrast to asystole where patients are likely to have no cerebral perfusion. In this study we attempt to detect any possible differences in neurological recovery (as indicated by the Cerebral Performance Category scale on hospital discharge) after therapeutic hypothermia, between patients arrested in PEA arrest and those arrested in asystole.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shockable arrest | – | Other: No treatment, Other: Therapeutic hypothermiaInitial arrest rhythm shockable. This is either pulseless ventricular tachycardia (pulseless VT) or ventricular fibrillation (VF). |
| Pulseless electrical activity | – | Other: No treatment, Other: Therapeutic hypothermiaInitial arrest rhythm is pulseless electrical activity. |
| Asystole | – | Other: No treatment, Other: Therapeutic hypothermiaInitial arrest rhythm is asystole. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the intensive care unit (ICU) with a diagnosis of postcardiac arrest between Jan 2008 and Dec 2012 will be examined.
Key inclusion criteria (4 listed)
- Admission to adult ICU (age ≥18 years) at London Health Sciences Centre
- Primary reason for ICU admission: postcardiac arrest
- Both in-hospital and out-of-hospital cardiac arrest will be included
- ICU admission between Jan 2008 and Dec 2012.
Key exclusion criteria (1 listed)
- ICU admissions primarily for reasons other than cardiac arrest.
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 |
|---|---|---|
| No treatmentAlso: No therapeutic hypothermia., Control.No therapeutic hypothermia was induced. | Other | Asystole, Pulseless electrical activity, Shockable arrest |
| Therapeutic hypothermiaAlso: Hypothermia, Induced hypothermia, Mild therapeutic hypothermia, CoolingHypothermia was induced after successful resuscitation from cardiac arrest. | Other | Asystole, Pulseless electrical activity, Shockable arrest |
Primary outcome
Cerebral performance category score on hospital discharge
Time frame: Upon discharge from hospital, assessed up to 36 months postcardiac arrest
Neurological outcome on discharge from hospital as defined by the cerebral performance category (CPC) scale. The CPC scale is a 5 point scale. The outcome measure will be dichotomized into good or bad. Good outcome will be equivalent to CPC scores of 1 \& 2 (where the patient is independent), and bad outcome will be equivalent to CPC scores of 3, 4 \& 5 (where the patient is either dependent or dead). CPC Scale: 1. Functioning normally and independent, possibly with a minor disability. 2. Moderately disabled, still independent. 3. Conscious but with a severe disability, dependent. 4. Unconscious (comatose or in a persistent vegetative state). 5. Brain dead or dead by traditional criteria.
3 secondary outcomes
Hospital length of stay postcardiac arrest
Time frame: Days spent in hospital after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest
Intensive care unit length of stay postcardiac arrest
Time frame: Days spent in the intensive care unit after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest
Neurological status after hospital discharge
Time frame: Assessed up to 12 months from hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
- Background: PubMed 20860507Holzer M. Targeted temperature management for comatose survivors of cardiac arrest. N Engl J Med. 2010 Sep 23;363(13):1256-64. doi: 10.1056/NEJMct1002402. No abstract available.
- 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.
- Background: PubMed 11856793Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.
- Background: PubMed 20956249Hazinski MF, Nolan JP, Billi JE, Bottiger BW, Bossaert L, de Caen AR, Deakin CD, Drajer S, Eigel B, Hickey RW, Jacobs I, Kleinman ME, Kloeck W, Koster RW, Lim SH, Mancini ME, Montgomery WH, Morley PT, Morrison LJ, Nadkarni VM, O'Connor RE, Okada K, Perlman JM, Sayre MR, Shuster M, Soar J, Sunde K, Travers AH, Wyllie J, Zideman D. Part 1: Executive summary: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S250-75. doi: 10.1161/CIRCULATIONAHA.110.970897. No abstract available.
- Background: PubMed 17334257Arrich J; European Resuscitation Council Hypothermia After Cardiac Arrest Registry Study Group. Clinical application of mild therapeutic hypothermia after cardiac arrest. Crit Care Med. 2007 Apr;35(4):1041-7. doi: 10.1097/01.CCM.0000259383.48324.35.
- Background: PubMed 21705132Testori C, Sterz F, Behringer W, Haugk M, Uray T, Zeiner A, Janata A, Arrich J, Holzer M, Losert H. Mild therapeutic hypothermia is associated with favourable outcome in patients after cardiac arrest with non-shockable rhythms. Resuscitation. 2011 Sep;82(9):1162-7. doi: 10.1016/j.resuscitation.2011.05.022. Epub 2011 Jun 12.
- Background: PubMed 21321156Dumas F, Grimaldi D, Zuber B, Fichet J, Charpentier J, Pene F, Vivien B, Varenne O, Carli P, Jouven X, Empana JP, Cariou A. Is hypothermia after cardiac arrest effective in both shockable and nonshockable patients?: insights from a large registry. Circulation. 2011 Mar 1;123(8):877-86. doi: 10.1161/CIRCULATIONAHA.110.987347. Epub 2011 Feb 14.
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.
Eyad AlThenayan, MD contact
Eyad Althenayan, MD principal investigator
Western University, Canada
Philip Jones, MD, FRCPC study director
Western University, Canada
Bryan Young, MD, FRCPC study chair
Western University, Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postcardiac Arrest and Pulseless Electrical Activity, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed F Hegazy, MD, FRCPC (1(519) 860-4917, ahmed.hegazy@londonhospitals.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral performance category score on hospital discharge (time frame: Upon discharge from hospital, assessed up to 36 months postcardiac arrest). 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 NCT02033720, which also lists 7 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 13 Jan 2014.