Out of Hospital Cardiac ArrestTHAWNCT03065946
Therapeutic Hypothermia and eArly Waking
An observational study of Out of Hospital Cardiac Arrest and Brain Injury, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Unconscious survivors of cardiac arrest who are treated with intravenous therapeutic hypothermia for 24 hours will be assessed after 12 hours for appropriateness to be woken early and extubated whilst continuing to receive therapeutic hypothermia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out of Hospital Cardiac Arrest, Brain Injury
- What is being tested?
- Early wakening
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Feb 2017to 28 Feb 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac arrest
Who may be able to join
- Post cardiac arrest with ROSC
- Planning to receive MTH as part of post-cardiac arrest care
Who cannot join
- Cardiac arrest caused by trauma, head injury, massive haemorrhage, drug overdose, cerebrovascular accident, drowning, electric shock or hanging.
- Do Not Attempt to Resuscitate (DNAR) orders
- Known terminal illness (e.g. malignancy in the end stages)
- Known or obvious pregnancy
- Known coagulation disorder (except those induced by medication)
- Known oxygen dependency
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- The patient has a height of <1.5 meters (4 feet 11 inches)
- The patient has a known hypersensitivity to Buspirone Hydrochloride or Pethidine
- Patient has a known history of severe hepatic or renal impairment, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture that in the opinion of the treating consultant would be incompatible with Pethidine administration
- The patient has an inferior Vena Cava (IVC) filter in place
- The patient has a known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL
About this study
Unconscious survivors of cardiac arrest who are treated with intravenous therapeutic hypothermia for 24 hours will be assessed after 12 hours for appropriateness to be woken early and extubated whilst continuing to receive therapeutic hypothermia. Sedation will be reduced/stopped at 12 hours to enable a comprehensive neurological assessment utilising a multimodal approach.
Providing the patient is clinically stable with no adverse neurological signs the patient will be extubated. Patients who remain unconscious will be reviewed 6 hourly for neurological recovery and their suitability to be extubated in line with standard practice.
Read the detailed description
This study is a single centre, prospective, feasibility and safety study. Consecutively enrolling 50 patients. Subjects will include adult patients who have suffered a cardiac arrest with a return of spontaneous circulation (ROSC).
To qualify, patients must be unconscious and intubated because their initial Glasgow Coma Score (GCS) is <8. Intravenous therapeutic hypothermia (TH) will be established in the cathlab and maintained for 24 hours whilst being cared for in the intensive Care Unit (ICU). IVTM will maintain the patient's core temperature at a target temperature between 32-34 degrees Celsius. After the patient has received 12 hours of TH, sedation will be stopped and the patient will have a comprehensive neurological assessment combining electroencephalogram (EEG), Somatic Sensory Evoked Potential (SSEP) and neurological biomarkers, Neuron Specific Enolase (NSE) and S100b. The EEG, SSEP and biomarkers will be reviewed by an expert in neurophysiology at a core lab off-site. These results will be reviewed retrospectively, therefore will not influence the medical management of the patient.
Patients who are clinically stable and not showing any adverse neurological signs will be extubated after 12 hours. Patients who don't meet the early waking criteria will reassessed every 6 hours for extubation. Those patients who are not suitable to be woken early or remain unconscious after 24 hours will be reassessed as per standard practice for unconscious survivors of cardiac arrest.
- Conditions
- Out of Hospital Cardiac Arrest, Brain Injury
- Being tested
- Early wakening
- Keywords
- Therapeutic hypothermia, Electroencephalogram, Neuron-Specific Enolase, Return of Spontaneous Circulation, S-100B
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early wakeningOther
By using an intravascular device to administer mild TH for 24 hours, patients can safely have their medically induced coma reversed early at 12 hours, allowing an accurate neurological assessment to be performed
| Study group | Role | What they receive |
|---|---|---|
| Case series | Early wakening Receives: Other: Early wakening |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of unconscious survivors following an OHCA, who are admitted to the ICU being treated with MTH who are clinically stable can be safely woken and extubated after 12 hours whilst continuing to receive therapeutic hypothermia.
Is it safe and feasible to wake patients early whilst receiving therapeutic hypothermia to assess their neurological function?
Measured: 12 hours
Secondary outcomes (8)
Reduction in ICU and hospital stay
Length of ICU and hospital stay
Measured: 24 hours
Reduction of Neurological recovery at 12 hours
Length of time to perform a neurological assessment and intervention
Measured: 24 hours
Reduction in the time to perform a CPC assessment
Length of time to perform a Cerebral Performance Category (CPC) assessment
Measured: 24 days
NSE and S100B values during early waking phase
Time of peak NSE and S100B
Measured: 2 days
Composite outcome off all-cause mortality and poor neurological function
Time taken to confirm poor neurological outcome or death
Measured: 7 days
Presence of EEG findings associated with seizures or poor prognosis
Time of identifying abnormal EEG findings associated with seizures or poor prognosis
Measured: 2 days
Presence of SSEP findings associated with poor prognosis
Time of identifying abnormal SSEP findings associated with poor prognosis
Measured: 2 Weeks
Safe to wake unconscious survivors whilst still providing IVTM
Length of time patients are unconscious whilst receiving IVTM
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start10 Feb 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out of Hospital 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Keeble, MBBS MD MRCP, Principal investigator, Basildon and Thurrock University Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065946
- Sponsor's protocol ID
- B784
- Acronym
- THAW
- Status last verified
- Dec 2020
- First submitted
- 20 Feb 2017
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Hypothermia and eArly Waking
- ClinicalTrials.gov ID
- NCT03065946
- Acronym / sponsor ID
- THAW / B784
- Conditions
- Out of Hospital Cardiac Arrest, Brain Injury
- Keywords
- Therapeutic hypothermia, Electroencephalogram, Neuron-Specific Enolase, Return of Spontaneous Circulation, S-100B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 28 Feb 2017 (actual)
- 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.
Unconscious survivors of cardiac arrest who are treated with intravenous therapeutic hypothermia for 24 hours will be assessed after 12 hours for appropriateness to be woken early and extubated whilst continuing to receive therapeutic hypothermia. Sedation will be reduced/stopped at 12 hours to enable a comprehensive neurological assessment utilising a multimodal approach.
Providing the patient is clinically stable with no adverse neurological signs the patient will be extubated. Patients who remain unconscious will be reviewed 6 hourly for neurological recovery and their suitability to be extubated in line with standard practice.
Detailed description
This study is a single centre, prospective, feasibility and safety study. Consecutively enrolling 50 patients. Subjects will include adult patients who have suffered a cardiac arrest with a return of spontaneous circulation (ROSC).
To qualify, patients must be unconscious and intubated because their initial Glasgow Coma Score (GCS) is <8. Intravenous therapeutic hypothermia (TH) will be established in the cathlab and maintained for 24 hours whilst being cared for in the intensive Care Unit (ICU). IVTM will maintain the patient's core temperature at a target temperature between 32-34 degrees Celsius. After the patient has received 12 hours of TH, sedation will be stopped and the patient will have a comprehensive neurological assessment combining electroencephalogram (EEG), Somatic Sensory Evoked Potential (SSEP) and neurological biomarkers, Neuron Specific Enolase (NSE) and S100b. The EEG, SSEP and biomarkers will be reviewed by an expert in neurophysiology at a core lab off-site. These results will be reviewed retrospectively, therefore will not influence the medical management of the patient.
Patients who are clinically stable and not showing any adverse neurological signs will be extubated after 12 hours. Patients who don't meet the early waking criteria will reassessed every 6 hours for extubation. Those patients who are not suitable to be woken early or remain unconscious after 24 hours will be reassessed as per standard practice for unconscious survivors of cardiac arrest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case series | – | Other: Early wakeningEarly wakening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac arrest
Key inclusion criteria (2 listed)
- Post cardiac arrest with ROSC
- Planning to receive MTH as part of post-cardiac arrest care
Key exclusion criteria (11 listed)
- Cardiac arrest caused by trauma, head injury, massive haemorrhage, drug overdose, cerebrovascular accident, drowning, electric shock or hanging.
- Do Not Attempt to Resuscitate (DNAR) orders
- Known terminal illness (e.g. malignancy in the end stages)
- Known or obvious pregnancy
- Known coagulation disorder (except those induced by medication)
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 |
|---|---|---|
| Early wakeningBy using an intravascular device to administer mild TH for 24 hours, patients can safely have their medically induced coma reversed early at 12 hours, allowing an accurate neurological assessment to be performed | Other | Case series |
Primary outcome
The number of unconscious survivors following an OHCA, who are admitted to the ICU being treated with MTH who are clinically stable can be safely woken and extubated after 12 hours whilst continuing to receive therapeutic hypothermia.
Time frame: 12 hours
Is it safe and feasible to wake patients early whilst receiving therapeutic hypothermia to assess their neurological function?
8 secondary outcomes
Reduction in ICU and hospital stay
Time frame: 24 hours
Reduction of Neurological recovery at 12 hours
Time frame: 24 hours
Reduction in the time to perform a CPC assessment
Time frame: 24 days
NSE and S100B values during early waking phase
Time frame: 2 days
Composite outcome off all-cause mortality and poor neurological function
Time frame: 7 days
Presence of EEG findings associated with seizures or poor prognosis
Time frame: 2 days
Presence of SSEP findings associated with poor prognosis
Time frame: 2 Weeks
Safe to wake unconscious survivors whilst still providing IVTM
Time frame: 2 Weeks
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 22 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Out of Hospital Cardiac Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
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.
Thomas Keeble, MBBS MD MRCP principal investigator
Basildon and Thurrock University Hospitals NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out of Hospital Cardiac Arrest and Brain Injury, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
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 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 22 Dec 2020. 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 Kingdom. 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?
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?
The number of unconscious survivors following an OHCA, who are admitted to the ICU being treated with MTH who are clinically stable can be safely woken and extubated after 12 hours whilst continuing to receive therapeutic hypothermia. (time frame: 12 hours). 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 22 Dec 2020.