StrokeRE-HIBERNCT04554797
Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke
A study testing Regional Hypothermia in people with Stroke and Neuroprotection, run by Capital Medical University at 2 sites in China.
Trial summary
The investigators have previous shown that regional hypothermia by the intra-arterial infusion of cold saline combined with mechanical thrombectomy in acute ischemic stroke is feasible and safe. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Neuroprotection, Hypothermia
- What is being tested?
- Regional Hypothermia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 16 Oct 2020to 16 Mar 2021
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤80
- Clinical signs consistent with the diagnosis of an acute ischemic stroke
- Baseline NIHSS score obtained prior to randomization ≥8
- Intracranial arterial occlusion of the distal intracranial carotid artery or
- Middle (M1/M2), demonstrated with CTA, MRA, DSA
- The possibility to start treatment (artery puncture) within 6 hours from onset
- Regional hypothermia is expected to start within 15 minutes after recanalization
- Informed consent given
Who cannot join
- mTICI<2b after endovascular treatment
- No significant pre-stroke disability (mRS ≤1)
- Previous NYHA grade > 1
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
- Baseline platelet count < 50000/µL
- Baseline blood glucose of < 50mg/dL or >400mg/dl
Show all 19Show fewer
- Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg). NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using local treatment guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
- Seizures at stroke onset which would preclude obtaining a baseline NIHSS
- Subjects who have received iv t-PA treatment beyond 4,5 hours from the beginning of the symptoms
- Renal insufficiency with creatinine ≥ 3 mg/dl
- Woman of childbearing potential who is known to be pregnant or lactating
- Subject participating in a study involving an investigational drug or device that would impact this study
- Cerebral vasculitis
- Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
- Unlikely to be available for 3 months follow-up (e.g. no fixed home address, visitor from overseas).
- CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed)
- ASPECT<6
- Subjects with occlusions in multiple vascular territories (anterior circulation and posterior circulation)
- Evidence of intracranial tumor (except small meningioma)
Trial locations and contacts
2 sites in 1 country.
Chuanjie Wu, MD contact
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Xunming Ji
Xunming Ji
- Not yet recruiting
Lu He hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
Xiaokun Geng, MD, 18311055270, xgeng@ccmu.edu.cn
About this study
The investigators have previous shown that regional hypothermia by the intra-arterial infusion of cold saline combined with mechanical thrombectomy in acute ischemic stroke is feasible and safe. The safety of selective brain cooling in patients undergoing mechanical thrombectomy, however, is not established in a randomized trial. The investigators therefore conducted this RCT study to further explore the safety of regional hypothermia in patients with acute ischemic stroke who underwent mechanical thrombectomy.
- Conditions
- Stroke, Neuroprotection, Hypothermia
- Being tested
- Regional Hypothermia
- Medical subject headings
- Stroke, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional HypothermiaOther
Regional hypothermia was achieved by intraarteral perfusion of cold fluid into the ischemic area of the brain
| Study group | Role | What they receive |
|---|---|---|
| Regional Hypothermia group | Experimental | Not described Receives: Other: Regional Hypothermia |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of any major adverse events
Measured: 7 days
Secondary outcomes (7)
Rate of intracerebral hemorrhage
Measured: 24 hours
Rate of symptomatic intracerebral hemorrhage
Measured: 24 hours
Rate of death
Measured: 90 days
NIHSS
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Measured: 24 hours
Final infarct volume
measured on 5-7 days CT (or MRI if available)
Measured: 5-7 days
NIHSS
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Measured: 7 days or discharge
Modified Rankin scale
The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death). A score of 2 or less indicates functional independence.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start16 Oct 2020 (estimated)
- Primary completion16 Dec 2020 (estimated)
- Study completion16 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554797
- Sponsor's protocol ID
- RE-HIBER
- Acronym
- RE-HIBER
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04554797
- Acronym / sponsor ID
- RE-HIBER / RE-HIBER
- Conditions
- Stroke, Neuroprotection, Hypothermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 16 Oct 2020 (estimated)
- Primary completion
- 16 Dec 2020 (estimated)
- Study completion
- 16 Mar 2021 (estimated)
- First posted
- 18 Sep 2020 (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.
The investigators have previous shown that regional hypothermia by the intra-arterial infusion of cold saline combined with mechanical thrombectomy in acute ischemic stroke is feasible and safe. The safety of selective brain cooling in patients undergoing mechanical thrombectomy, however, is not established in a randomized trial. The investigators therefore conducted this RCT study to further explore the safety of regional hypothermia in patients with acute ischemic stroke who underwent mechanical thrombectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional Hypothermia group | Experimental | Other: Regional Hypothermia |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 and ≤80
- Clinical signs consistent with the diagnosis of an acute ischemic stroke
- Baseline NIHSS score obtained prior to randomization ≥8
- Intracranial arterial occlusion of the distal intracranial carotid artery or
- Middle (M1/M2), demonstrated with CTA, MRA, DSA
Key exclusion criteria (19 listed)
- mTICI<2b after endovascular treatment
- No significant pre-stroke disability (mRS ≤1)
- Previous NYHA grade > 1
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
- Baseline platelet count < 50000/µL
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 |
|---|---|---|
| Regional HypothermiaRegional hypothermia was achieved by intraarteral perfusion of cold fluid into the ischemic area of the brain | Other | Regional Hypothermia group |
Primary outcome
Rate of any major adverse events
Time frame: 7 days
7 secondary outcomes
Rate of intracerebral hemorrhage
Time frame: 24 hours
Rate of symptomatic intracerebral hemorrhage
Time frame: 24 hours
Rate of death
Time frame: 90 days
NIHSS
Time frame: 24 hours
Final infarct volume
Time frame: 5-7 days
NIHSS
Time frame: 7 days or discharge
Modified Rankin scale
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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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.
Chuanjie Wu, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional Hypothermia in people with Stroke and Neuroprotection, run by Capital Medical University at 2 sites in China.
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 8 inclusion and 19 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 19 Oct 2020. 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 China. 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 Xunming Ji, MD (01083199439, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of any major adverse events (time frame: 7 days). 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 19 Oct 2020.