Ischemic StrokePhase 2HAIS-SENCT01665885
Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE)
A Phase 2 study testing ZOLL Thermogard XP and BARD/Medivance Arctic Sun 5000 in people with Ischemic Stroke and Thrombolysis, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Stroke, Thrombolysis, Hypothermia
- What is being tested?
- ZOLL Thermogard XP and BARD/Medivance Arctic Sun 5000
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Nov 2015
- Phase
- Phase 2
- 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
Who may be able to join
- Ischemic stroke
- Intravenous thrombolysis within 4.5h from symptom onset
- Informed consent of the patient
- NIHSS score ≥ 2 and ≤ 20
- Age ≥ 18 and ≤ 90 years
- Placement of cooling catheter / cooling pads within 6h from symptom onset
Who cannot join
- (Expected) intubation (e.g. for interventional treatment)
- Pregnancy
- Body weight > 120kg
- Body height < 150cm
- Life-expectancy < 3 months
- Fever > 38.5°C at screening
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- Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
- Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
- Possible compression of the inferior vena cava (e.g. due to tumor) or vena cava filter
- Acute pulmonary embolism
- Acute myocardial infarction
- Severe cardiac insufficiency (NYHA ≥ III)
- Threatening ventricular dysrhythmia
- QTc-interval > 450ms
- Bradycardia < 50/min
- Sick-Sinus-Syndrom
- AV-block > I°
- Severe infection with bacteremia or sepsis ≤ 72h
- Severe renal (GFR < 30ml/min) or liver insufficiency (Child-Pugh C)
- Myopathy
- Known intolerance or allergy against acetaminophen, buspirone, clonidine, magnesium sulphate or pethidine.
- Treatment with MAO-inhibitors ≤ 14 days
- Acute closed-angle glaucoma
Trial locations and contacts
1 site in 1 country.
Germany1 site
Stroke Unit, Dept. of Neurology, University Hospital Heidelberg
Heidelberg, 69120
About this study
Official title: HAIS-SE (Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling): A Randomized Trial Comparing Surface Versus Endovascular Cooling in Awake Stroke Patients Treated With Thrombolysis
HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.
Read the detailed description
Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Via animal models hypothermia has been identified as the most promising neuroprotective therapy in focal cerebral ischemia as well. But the prove of clinical benefit in patients with acute ischemic stroke is still missing: Most likely due to the prolonged time window until hypothermia-induction (14 h) in previous studies. In addition, feasibility of the method through which hypothermia is applied is crucial for a broad implementation of hypothermia in stroke therapy. Surface versus endovascular cooling have never been compared in a prospective trial in awake stroke patients.
HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.
- Conditions
- Ischemic Stroke, Thrombolysis, Hypothermia
- Being tested
- ZOLL Thermogard XP, BARD/Medivance Arctic Sun 5000
- Keywords
- hypothermia, induction of hypothermia, non invasive cooling, external cooling, surface cooling, endovascular cooling, cooling catheter, stroke, shivering, neuro monitoring, coagulation
- Medical subject headings
- Ischemic Stroke, Hypothermia, Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZOLL Thermogard XPDevice
Also called ZOLL Thermogard XP cooling device, ZOLL Circulation, Inc., USA, ZOLL Quattro cooling catheter, ZOLL Circulation, Inc., USA
Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution). Cooling catheter placement at the earliest 30min after end of thrombolysis.
BARD/Medivance Arctic Sun 5000Device
Also called BARD/Medivance Arctic Sun 5000, C. R. Bard, Inc., USA, BARD/Medivance Arctic Gel Pads, C. R. Bard, Inc., USA
Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution) and simultaneous start of surface cooling.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular cooling | Active comparator | Endovascular cooling using the cooling device ZOLL Thermogard XP with ZOLL Quattro cooling catheter Receives: Device: ZOLL Thermogard XP |
| Surface cooling | Active comparator | Surface cooling using the cooling device BARD/Medivance Arctic Sun 5000 with BARD/Medivance Arctic Gel Pads Receives: Device: BARD/Medivance Arctic Sun 5000 |
| Control group | No intervention | Best medical treatment following international stroke guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body core temperature
Primary endpoint: Time to primary target body core temperature (34°C) after hypothermia-induction.
Measured: 0 to 48h
Secondary outcomes (4)
Efficacy
Secondary efficacy outcome measures include the amount of patients reaching the primary target body core temperature (34°C), the time-frame until reaching 35°C body core temperature, temperature stability during maintenance and rewarming.
Measured: 0 to 48h
Tolerability
Tolerability outcome measures include a specific Hypothermia Participant Experience Questionnaire (HPEQ) and the Bedside Shivering Assessment Scale (BSAS) plus correlation with skin temperature, EMG and sNIRS.
Measured: 0 to 48h
Practicability
Practicability outcome measures include a specific Hypothermia Nursing Staff Experience Questionnaire (HNEQ).
Measured: 0 to 48h
Safety
Safety outcome measures include the analysis of (severe) adverse events (e.g. bleeding complications, pneumonia). 0 to 48h: Dose needed of anti-shivering medication, level of sedation (RASS, GCS and BIS), safety laboratory including specific coagulation parameters and monitoring of cerebral auto-regulation including cNIRS and BIS.
Measured: 0 to d90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- ZOLL Circulation, Inc., USA
- Responsible party
- Principal investigator, Dr. Sven Poli, MD MSc FESO, University Hospital Heidelberg
- Investigators
- Sven Poli, Dr. med., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665885
- Sponsor's protocol ID
- HAIS-SE
- Acronym
- HAIS-SE
- Status last verified
- Jun 2013
- First submitted
- 13 Aug 2012
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAIS-SE (Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling): A Randomized Trial Comparing Surface Versus Endovascular Cooling in Awake Stroke Patients Treated With Thrombolysis
- ClinicalTrials.gov ID
- NCT01665885
- Acronym / sponsor ID
- HAIS-SE / HAIS-SE
- Conditions
- Ischemic Stroke, Thrombolysis, Hypothermia
- Keywords
- hypothermia, induction of hypothermia, non invasive cooling, external cooling, surface cooling, endovascular cooling, cooling catheter, stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- ZOLL Circulation, Inc., USA
- Study start
- Aug 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 15 Aug 2012 (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.
HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.
Detailed description
Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Via animal models hypothermia has been identified as the most promising neuroprotective therapy in focal cerebral ischemia as well. But the prove of clinical benefit in patients with acute ischemic stroke is still missing: Most likely due to the prolonged time window until hypothermia-induction (14 h) in previous studies. In addition, feasibility of the method through which hypothermia is applied is crucial for a broad implementation of hypothermia in stroke therapy. Surface versus endovascular cooling have never been compared in a prospective trial in awake stroke patients.
HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endovascular cooling | Active comparator | Device: ZOLL Thermogard XPEndovascular cooling using the cooling device ZOLL Thermogard XP with ZOLL Quattro cooling catheter |
| Surface cooling | Active comparator | Device: BARD/Medivance Arctic Sun 5000Surface cooling using the cooling device BARD/Medivance Arctic Sun 5000 with BARD/Medivance Arctic Gel Pads |
| Control group | No intervention | –Best medical treatment following international stroke guidelines |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ischemic stroke
- Intravenous thrombolysis within 4.5h from symptom onset
- Informed consent of the patient
- NIHSS score ≥ 2 and ≤ 20
- Age ≥ 18 and ≤ 90 years
Key exclusion criteria (23 listed)
- (Expected) intubation (e.g. for interventional treatment)
- Pregnancy
- Body weight > 120kg
- Body height < 150cm
- Life-expectancy < 3 months
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 |
|---|---|---|
| ZOLL Thermogard XPAlso: ZOLL Thermogard XP cooling device, ZOLL Circulation, Inc., USA, ZOLL Quattro cooling catheter, ZOLL Circulation, Inc., USAInduction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution). Cooling catheter placement at the earliest 30min after end of thrombolysis. | Device | Endovascular cooling |
| BARD/Medivance Arctic Sun 5000Also: BARD/Medivance Arctic Sun 5000, C. R. Bard, Inc., USA, BARD/Medivance Arctic Gel Pads, C. R. Bard, Inc., USAInduction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution) and simultaneous start of surface cooling. | Device | Surface cooling |
Primary outcome
Body core temperature
Time frame: 0 to 48h
Primary endpoint: Time to primary target body core temperature (34°C) after hypothermia-induction.
4 secondary outcomes
Efficacy
Time frame: 0 to 48h
Tolerability
Time frame: 0 to 48h
Practicability
Time frame: 0 to 48h
Safety
Time frame: 0 to d90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- Heidelberg HYPOthermia 24/7 - Research group, information and contactsLink provided by the sponsor.
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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.
Sven Poli, Dr. med. principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZOLL Thermogard XP and BARD/Medivance Arctic Sun 5000 in people with Ischemic Stroke and Thrombolysis, run by University Hospital Heidelberg 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 6 inclusion and 23 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 18 Feb 2015. 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. 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 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?
Results are not available in the source record.
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?
Body core temperature (time frame: 0 to 48h). 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 18 Feb 2015.