HypothermiaNCT04695236
A Trial of Intravascular Hypothermia Therapy in Acute Ischemic Stroke Patients
A study testing ZOLL Intravascular Temperature Management system, Quattro catheter and Standard Treatment in people with Hypothermia and Reperfusion Injury, run by jiaoliqun at 1 site in China.
Trial summary
Acute ischemic stroke (AIS) has been one of the major causes of global mortality and morbidity. The superiority of endovascular therapy (EVT) over standard medical therapy in treating AIS due to large vessel occlusion (LVO) in the anterior circulation has been widely accepted. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypothermia, Reperfusion Injury, Ischemic Stroke
- What is being tested?
- ZOLL Intravascular Temperature Management system, Quattro catheter and Standard Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2020to 31 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old
- Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (internal carotid artery, middle cerebral artery M1 or M2 segment)
- ASPECTS score 0-10
- Arterial puncture could be performed within 24 hours from symptom onset or LKN
- Baseline NIHSS (NIHSS) score prior to randomization ≥ 10 and NIHSS 1a ≥ 1
- Candidate for endovascular thrombectomy therapy in accordance with best practices per AHA standard stroke guidelines meeting all labeling requirements for EVT in the trial
Show all 9Show fewer
- Successful recanalization of occluded vessel (mTICI 2b-3) after EVT
- No intracranial hemorrhage postoperative CT examinations immediately after recanalization. If the subject' recanalization of vessel could not achieve mTICI 2b-3, the subject could not enter the per-protocol analysis and will separate another group
- Informed consent form signed by subjects or their legal guardian
Who cannot join
- Subject who suffer serious infection (e.g. sepsis) or multiple organ failure
- Known presence of an IVC filter
- End stage renal disease on hemodialysis
- Known hypersensitivity to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics
- Known hypersensitivity to the components of the medical device
- Any known history of the following conditions: bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, will refuse blood transfusions or contraindication to heparin; history of genetically confirmed hypercoagulable syndrome
Show all 26Show fewer
- Use of warfarin with INR > 3
- Hemodynamically significant cardiac dysrhythmias (eg. QTc interval >450 msec, bradycardia (heart rate less than 50), Mobitz Type II second degree AV block (or higher AV block), and severe ventricular dysrhythmias (sustained VT or VF)) which cause significant hypotension (SBP ≤ 120 mmHg requiring more than two pressor medications)
- Platelet count<40×10^9/L
- Blood glucose concentration <2.7 or > 22.2 mmol/L
- Hypertension uncontrollable by drug treatment (systolic blood pressure≥185 mmHg or diastolic blood pressure≥110mmhg)
- Expected life expectancy<6 months
- Temperature < 35°C on admission to Emergency Department
- With a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
- Subject participating in a study involving an investigational drug or device that would impact the current study
- Baseline CT/MR evidence of multiple vascular territory acute stroke
- Baseline CT/MR showing evidence of arterial vasculitis or dissection
- Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy
- Evidence of intracranial hemorrhage or hemorrhagic transformation immediately after thrombectomy
- Presence of pulmonary embolism, ilio-femoral or deep vein thrombosis
- Brain vascular lesion (e.g. aneurysm or arteriovenous malformation)
- Brain tumor or CNS infection
- Concurrent participation in a study involving an investigational drug or device that would impact the current study
- Female patient of childbearing potential who is known to be pregnant or lactating
- For other reasons, the researchers believe that the patient is not suitable for continued treatment
- Patients without a legally authorized representative to sign the consent form will be excluded
Trial locations and contacts
1 site in 1 country.
Xin Qu,MD contact
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing
Liqun Jiao,MD, Phd, 86-10-83199060, liqunjiao@sina.cn
About this study
Official title: A Prospective, Multicenter, Randomized Clinical Trial to Evaluate the Safety and Efficacy of Intravascular Hypothermia Therapy of Patients With Acute Ischemic Stroke
Acute ischemic stroke (AIS) has been one of the major causes of global mortality and morbidity. The superiority of endovascular therapy (EVT) over standard medical therapy in treating AIS due to large vessel occlusion (LVO) in the anterior circulation has been widely accepted. However, a critical concern is that even with an extremely high rate of successful recanalization (the modified thrombolysis in cerebral infarction [mTICI] score 2b-3) around 90%, nearly half of the patients failed to benefit from EVT. So, adjunctive therapy of EVT for neuroprotection is required.
From the previous domestic and foreign literatures, hypothermia can prevent and treat secondary injury caused by ischemia-reperfusion injury and cerebral edema of acute cerebral ischemia, so as to achieve the role of neuroprotection. In this study, intravascular cooling was performed as soon as possible with careful temperature control in patients receiving thrombectomy. The temperature was controlled at 33° C for 48-72 hours. This parallel controlled study is to systematically evaluate the feasibility and safety of adjunctive therapy using early intravascular hypothermia in AIS patients receiving mechanical thrombectomy. The results will clarify a potential modality for neuroprotection and hopefully provide new evidence in improving patient prognosis.
Read the detailed description
In this study, the target subjects were AIS patients with successful recanalization (mTICI 2b-3). Early intravascular hypothermia neuroprotection therapy was given to patients after thrombectomy to evaluate its safety and effectiveness. The neuroprotection effect of endovascular hypothermia therapy is explored regarding several aspects, such as hemorrhagic conversion rate, cerebral edema, and neurological function recovery, with specific evaluation criteria described in detail in the following experimental design.
- Conditions
- Hypothermia, Reperfusion Injury, Ischemic Stroke, Thrombectomy
- Being tested
- ZOLL Intravascular Temperature Management system, Quattro catheter, Standard Treatment
- Medical subject headings
- Hypothermia, Reperfusion Injury, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZOLL Intravascular Temperature Management system, Quattro catheterDevice
ZOLL Intravascular Temperature Management system, Quattro catheter
Standard TreatmentOther
Standard Treatment for Ischemic Strokre
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Study Group: Intravascular hypothermia therapy group ZOLL Intravascular Temperature Management system, Quattro catheter will be used in study group Receives: Device: ZOLL Intravascular Temperature Management system, Quattro catheter |
| Control group | Placebo comparator | Control group: Without intravascular hypothermia therapy group
ZOLL Intravascular Temperature Management system, Quattro catheter will not be used in control group Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial hemorrhage conversion rate
ICH
Measured: 7 days after thrombectomy operation or discharge
Secondary outcomes (7)
Modified Rankin scale (mRS)
The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (death)
Measured: 90 days
The rate of functional independency (mRS 0-2)
The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (death)
Measured: 90 days
The rate of mortality (mRS 6)
The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (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, 7 days or discharge
Rate of symptomatic intracranial hemorrhage (sICH)
The diagnosis of sICH was based on the association of ICH with any of the following. conditions: (1) Increase in NIHSS score > 4 points compared to the score before ICH; (2) Increase in NIHSS score by >2 points in one category; (3) deterioration leading to intubation, hemicraniectomy, external ventricular drain placement, or any other major interventions.
Measured: 7 days after thrombectomy operation or discharge
Rate of malignant cerebral edema
Development of signs of herniation (including decrease in consciousness and/or anisocoria), accompanied by midline shift >= 5 mm on follow-up imaging.
Measured: 7 days after thrombectomy operation or discharge
Infarct volume
measured on 5-7 days CT (or MRI if available)
Measured: 5-7 days after thrombectomy operation or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start31 Dec 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- jiaoliqun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, jiaoliqun, Xuanwu Hospital, Beijing
- Investigators
- Liqun Jiao,MD, PhD, Principal investigator, Department of Neurosurgery & Interventional Neuroradiology Xuanwu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695236
- Sponsor's protocol ID
- ASPIRE
- Status last verified
- Jun 2022
- First submitted
- 1 Jan 2021
- Last updated
- 6 Jun 2022
- 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 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Clinical Trial to Evaluate the Safety and Efficacy of Intravascular Hypothermia Therapy of Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04695236
- Acronym / sponsor ID
- ASPIRE
- Conditions
- Hypothermia, Reperfusion Injury, Ischemic Stroke, Thrombectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- jiaoliqunUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Jan 2021 (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.
Acute ischemic stroke (AIS) has been one of the major causes of global mortality and morbidity. The superiority of endovascular therapy (EVT) over standard medical therapy in treating AIS due to large vessel occlusion (LVO) in the anterior circulation has been widely accepted. However, a critical concern is that even with an extremely high rate of successful recanalization (the modified thrombolysis in cerebral infarction [mTICI] score 2b-3) around 90%, nearly half of the patients failed to benefit from EVT. So, adjunctive therapy of EVT for neuroprotection is required.
From the previous domestic and foreign literatures, hypothermia can prevent and treat secondary injury caused by ischemia-reperfusion injury and cerebral edema of acute cerebral ischemia, so as to achieve the role of neuroprotection. In this study, intravascular cooling was performed as soon as possible with careful temperature control in patients receiving thrombectomy. The temperature was controlled at 33° C for 48-72 hours. This parallel controlled study is to systematically evaluate the feasibility and safety of adjunctive therapy using early intravascular hypothermia in AIS patients receiving mechanical thrombectomy. The results will clarify a potential modality for neuroprotection and hopefully provide new evidence in improving patient prognosis.
Detailed description
In this study, the target subjects were AIS patients with successful recanalization (mTICI 2b-3). Early intravascular hypothermia neuroprotection therapy was given to patients after thrombectomy to evaluate its safety and effectiveness. The neuroprotection effect of endovascular hypothermia therapy is explored regarding several aspects, such as hemorrhagic conversion rate, cerebral edema, and neurological function recovery, with specific evaluation criteria described in detail in the following experimental design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: ZOLL Intravascular Temperature Management system, Quattro catheterStudy Group: Intravascular hypothermia therapy group ZOLL Intravascular Temperature Management system, Quattro catheter will be used in study group |
| Control group | Placebo comparator | Other: Standard TreatmentControl group: Without intravascular hypothermia therapy group ZOLL Intravascular Temperature Management system, Quattro catheter will not be used in control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 80 years old
- Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (internal carotid artery, middle cerebral artery M1 or M2 segment)
- ASPECTS score 0-10
- Arterial puncture could be performed within 24 hours from symptom onset or LKN
- Baseline NIHSS (NIHSS) score prior to randomization ≥ 10 and NIHSS 1a ≥ 1
Key exclusion criteria (26 listed)
- Subject who suffer serious infection (e.g. sepsis) or multiple organ failure
- Known presence of an IVC filter
- End stage renal disease on hemodialysis
- Known hypersensitivity to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics
- Known hypersensitivity to the components of the medical device
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 Intravascular Temperature Management system, Quattro catheterZOLL Intravascular Temperature Management system, Quattro catheter | Device | Study group |
| Standard TreatmentStandard Treatment for Ischemic Strokre | Other | Control group |
Primary outcome
Intracranial hemorrhage conversion rate
Time frame: 7 days after thrombectomy operation or discharge
ICH
7 secondary outcomes
Modified Rankin scale (mRS)
Time frame: 90 days
The rate of functional independency (mRS 0-2)
Time frame: 90 days
The rate of mortality (mRS 6)
Time frame: 90 days
NIHSS
Time frame: 24 hours, 7 days or discharge
Rate of symptomatic intracranial hemorrhage (sICH)
Time frame: 7 days after thrombectomy operation or discharge
Rate of malignant cerebral edema
Time frame: 7 days after thrombectomy operation or discharge
Infarct volume
Time frame: 5-7 days after thrombectomy operation or discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
Related trials for Hypothermia
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Not yet recruiting
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
Pediatric Liver Transplantation
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.
Xin Qu,MD contact
Liqun Jiao,MD, PhD principal investigator
Department of Neurosurgery & Interventional Neuroradiology Xuanwu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZOLL Intravascular Temperature Management system, Quattro catheter and Standard Treatment in people with Hypothermia and Reperfusion Injury, run by jiaoliqun at 1 site 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 9 inclusion and 26 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 6 Jun 2022. 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 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. 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.
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 Liqun Jiao,MD, PhD (13911224991, liqunjiao@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial hemorrhage conversion rate (time frame: 7 days after thrombectomy operation or discharge). 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 6 Jun 2022.