Status:
UNKNOWN
A Trial of Intravascular Hypothermia Therapy in Acute Ischemic Stroke Patients
Lead Sponsor:
jiaoliqun
Conditions:
Hypothermia
Reperfusion Injury
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
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 ev...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
December 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04695236
Start Date
December 31 2020
End Date
December 31 2022
Last Update
June 6 2022
Active Locations (1)
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1
Xuanwu Hospital
Beijing, China