An interventional study of Mechanical thrombectomy and 4°C saline infusion in Acute Cerebrovascular Accident, Acute Ischemic Stroke and Internal Carotid Artery, sponsored by Guangdong Second Provincial General Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Guangdong Second Provincial General Hospital · Not applicable, Interventional, and Treatment
A multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial to assess the effectiveness and safety of catheter-based focal intracranial hypothermia combined with endovascular reperfusion therapy for patients with acute anterior circulation large artery occlusion.
This trial aims to assess the effectiveness and safety of catheter-based focal intracranial hypothermia combined with endovascular reperfusion therapy for patients with acute anterior circulation large artery occlusion. This study used a stratified randomization method, with participants randomly allocated in a 1:1 ratio by a central network randomization system to either the mechanical thrombectomy (MT) combined with arterial selective cooling infusion (intravenous recombinant tissue plasminogen activator) (hypothermia) group or the MT combined with normal saline infusion (normothermia) group (hereinafter referred to as the hypothermia group or normothermia group). Randomization was stratified by ASPECTS score (≥8 or \<8) and age (≥75 years or \<75 years).
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's enrollment of 262 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Guangdong Second Provincial General Hospital is the lead sponsor of 15 studies on the registry; 11 are open to participants now.
Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
6.Patients with heart function of grade 1 or above, or with a clear history of acute or chronic heart dysfunction, are at greater risk of acute heart failure or fluid perfusion intolerance as determined by clinicians.
7. Severe heart, liver, kidney disease. 8.With malignant diseases such as malignant tumors, the expected survival time is less than 3 months.
9.Participating in other clinical trials, in the phase or in the follow-up phase.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
Procedure: Mechanical thrombectomy · Drug: 4°C saline infusion
Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
Procedure: Mechanical thrombectomy · Drug: Normothermic saline infusion
Mechanical thrombectomy
Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
Proportion of patients with modified Rankin Score 0-2 at 90 days.
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Time frame: 90 days after procedure
Proportion of patients with modified Rankin Score 0-1 at 90 days
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Time frame: 90 days after procedure
Successful reperfusion rate
Successful reperfusion was indicated by modified Thrombolysis in Cerebral Infarction (mTICI) grade 2b or 3.
Time frame: At the end of the operation
Cerebral infarction volume was measured by CT or magnetic resonance DWI 72 hours to 7 days after operation
Cerebral infarction volume was measured by CT or DWI 72 hours to 7 days after operation.
Time frame: 72 hours to 7 days after procedure
Incidence of early neurological deterioration
Early neurological deterioration was defined as an increase of 4 or more points on the NIHSS within 24 hours that was not attributable to intracerebral hemorrhage.
Time frame: Within 24 hours after procedure
Rate of recurrent occlusion on MRA or CTA (postoperative 24 Hours to 7 Days)
Recurrent occlusion was measured by MRA or CTA 24 hours to 7 days after operation.
Time frame: postoperative 24 Hours to 7 Days
Rate of symptomatic intracranial hemorrhage within 72 hours (Heidelberg Bleeding Classification)
Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 72 hours of endovascular treatment. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma. The sICH was defined as ICH associated with a worsening of 4 or more points on the NIHSS or resulting in death, and cerebral herniation, which were not present at baseline.
Time frame: Within 72 hours after procedure
Rate of coagulation disorders
Rate of coagulation disorders within 7 days
Time frame: 7 days
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Guangdong Second Provincial General Hospital