An interventional study of Mechanical thrombectomy and Normothermic saline infusion in Acute Ischemic Stroke and Basilar Artery Occlusion, sponsored by Guangdong Second Provincial General Hospital. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Guangdong Second Provincial General Hospital · Not applicable, Interventional, and Treatment
This study will examine whether cooling part of the brain through a catheter after endovascular treatment improves recovery in adults with acute basilar artery occlusion, a type of severe stroke. After blood flow has been successfully restored, 818 participants will be randomly assigned to receive either cold saline or room-temperature saline through an artery. The main outcome is the level of disability 90 days later, measured using the modified Rankin Scale. The study will also assess safety, including bleeding in the brain and other complications.
This is a multicenter, prospective, randomized, open-label trial with blinded outcome assessment. It will compare selective intra-arterial hypothermia with a room-temperature saline control in adults with acute basilar artery occlusion who achieve successful reperfusion after endovascular treatment. Randomization will occur after successful reperfusion is confirmed.
Participants will be assigned in a 1:1 ratio to one of two groups. The hypothermia group will receive 350 mL of 4°C normal saline through an intra-arterial catheter at a fixed rate of 30 mL/min. The control group will receive 350 mL of room-temperature normal saline (22-25°C) through the same arterial route and at the same rate. The planned enrollment is 818 participants.
The primary outcome is the distribution of modified Rankin Scale scores, from 0 (no symptoms) to 6 (death), at 90 days after randomization. This outcome will be evaluated using a shift analysis across the full scale. Outcome assessors will be unaware of group assignments. The study will also evaluate other functional outcomes and adverse events.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 818 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.
Counted across the registry records on this site, refreshed daily.
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.
(1)Successful recanalization of the basilar artery after endovascular treatment; (2)Definition of successful recanalization: eTICI grade reaching 2b, 2c,or 3; 9.The patient or their legal guardian is able to understand the purpose of the trial, voluntarily participate and sign a written form, and is capable of undergoing clinical follow-up.
Exclusion Criteria:
(1)Sick sinus syndrome (SSS); (2)Second-degree type II or third-degree atrioventricular block (without pacemaker implantation); (3)Baseline heart rate \<50 bpm or >500 ms; (4)History of severe heart failure ( \<30%); 3.Severe clinical status:
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following successful reperfusion with endovascular treatment (EVT), participants in the hypothermia group will receive a selective intra-arterial infusion of 350 mL of 4°C normal saline at a fixed rate of 30 mL/min. No dose escalation will be performed.
Procedure: Mechanical thrombectomy · Drug: 4°C saline infusion
Receive a total of 350 ml of room temperature (22-25°C) saline infusion based on EVT treatment; the infusion rate is the same as that of the hypothermia group
Procedure: Mechanical thrombectomy · Drug: Normothermic saline infusion
Mechanical thrombectomy
Participants in the normothermia group will receive a total of 350 mL of room-temperature (22-25°C) normal saline by intra-arterial infusion following endovascular treatment (EVT), at the same fixed rate as the hypothermia group: 30 mL/min.
Following successful reperfusion with endovascular treatment (EVT), participants in the hypothermia group will receive a selective intra-arterial infusion of 350 mL of 4°C normal saline at a fixed rate of 30 mL/min. No dose escalation will be performed.
Distribution of Modified Rankin Scale Scores at 90 Days
The distribution of modified Rankin Scale (mRS) scores at 90 (±7) days after randomization will be assessed across all seven categories (0-6) using a shift analysis. Scores range from 0 (no symptoms) to 6 (death); lower scores indicate less disability.
Time frame: 90 (±7) days after randomization
mortality at 90 (±7) days
All-cause mortality at 90 (±7) days after randomization.
Time frame: 90 (±7) days after randomization
Independent ambulation
The proportion of participants with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization will be assessed. The mRS ranges from 0 (no symptoms) to 6 (death); lower scores indicate less disability.
Time frame: 90 (±7) days after randomization
Functional independence
The proportion of participants with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization will be assessed. The mRS ranges from 0 (no symptoms) to 6 (death); lower scores indicate less disability.
Time frame: 90 (±7) days after randomization
Excellent outcome
The proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90 (±7) days after randomization will be assessed. The mRS ranges from 0 (no symptoms) to 6 (death); lower scores indicate less disability.
Time frame: 90 (±7) days after randomization
Quality of life score
Health-related quality of life at 90 (±7) days after randomization will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Index scores calculated using the Chinese value set range from -0.391 (the worst health state) to 1 (full health); higher scores indicate better health-related quality of life.
Time frame: 90 (±7) days after randomization
Cerebral infarction volume
Cerebral infarction volume measured on CT or diffusion-weighted MRI obtained between 72 hours and 7 days after the procedure (MRI preferred).
Time frame: Between 72 hours and 7 days after the procedure
Vascular Re-occlusion Rate
Proportion of participants with re-occlusion of the originally occluded artery or a distal vessel, assessed by CTA or MRA between 24 hours and 7 days after the procedure.
Time frame: Between 24 hours and 7 days after the procedure
Symptomatic Intracranial Hemorrhage Within 72 Hours
The proportion of participants who develop symptomatic intracranial hemorrhage within 72 hours after the procedure will be assessed according to the Heidelberg Bleeding Classification. Symptomatic intracranial hemorrhage is defined as a new hemorrhage identified on brain imaging associated with neurological deterioration, indicated by an increase of ≥4 points in the total National Institutes of Health Stroke Scale (NIHSS) score, an increase of ≥2 points in a single NIHSS item, or deterioration requiring a major medical or surgical intervention, such as intubation, decompressive hemicraniectomy, or external ventricular drainage, with no alternative explanation for the deterioration. Changes in NIHSS scores are measured relative to the assessment immediately before deterioration. Total NIHSS scores range from 0 to 42, with higher scores indicating greater neurological impairment. This outcome is recorded as present or absent; the Heidelberg Bleeding Classification does not yield a numer
Time frame: Within 72 hours after the procedure
Any Intracranial Hemorrhage
The proportion of participants with any intracranial hemorrhage detected on protocol-specified computed tomography (CT) or magnetic resonance imaging (MRI) will be assessed through day 7 (±1 day) after the procedure or discharge, whichever occurs first. Both symptomatic and asymptomatic hemorrhages will be included. Hemorrhages will be categorized according to the Heidelberg Bleeding Classification, which describes the anatomical location and pattern of bleeding and does not yield a numerical total score. This outcome is recorded as present or absent; minimum and maximum scale scores are not applicable. A higher proportion indicates a worse safety outcome.
Time frame: Through day 7 (±1 day) after the procedure or discharge, whichever occurs first
Severe Pneumonia
Proportion of participants with a new pulmonary infection confirmed by chest imaging that requires endotracheal intubation, re-intubation after extubation due to pneumonia, prolongation of existing intubation by at least 48 hours for pneumonia treatment, or tracheostomy.
Time frame: Periprocedural
Fatal Perioperative Arrhythmia
Proportion of participants who experience a perioperative cardiac arrhythmia resulting in death.
Time frame: Periprocedural
Cerebral herniation
Proportion of participants who develop cerebral herniation.
Time frame: Periprocedural
Bradycardia
Proportion of participants with bradycardia, defined as a heart rate below 50 beats per minute lasting longer than 1 minute.
Time frame: Periprocedural
Coagulation Abnormalities
Proportion of participants who develop a coagulation abnormality, including abnormal clotting that may result in excessive bleeding or abnormal blood clot formation.
Time frame: Periprocedural
Electrolyte Disturbances
Proportion of participants who develop an electrolyte disturbance.
Time frame: Periprocedural
Intracranial Vasospasm
Proportion of participants who develop intracranial vasospasm.
Time frame: Periprocedural
Deep Vein Thrombosis
Proportion of participants who develop deep vein thrombosis during the index hospitalization.
Time frame: Periprocedural
All-Cause Mortality at 12 Months
Proportion of participants who die from any cause within 12 months after randomization.
Time frame: From randomization through 12 months (±30 days)
Distribution of Modified Rankin Scale Scores at 12 Months
The distribution of modified Rankin Scale (mRS) scores at 12 months (±30 days) after randomization will be assessed across all seven categories (0-6) using a shift analysis. Scores range from 0 (no symptoms) to 6 (death); lower scores indicate less disability.
Time frame: 12 months (±30 days) after randomization
Modified Rankin Scale Score of 0-3 at 12 Months
The proportion of participants with a modified Rankin Scale (mRS) score of 0-3 at 12 months (±30 days) after randomization will be assessed. The mRS ranges from 0 (no symptoms) to 6 (death); lower scores indicate less disability.
Time frame: 12 months (±30 days) after randomization
Plan to share: Yes — De-identified individual participant data underlying the results reported in the primary publication, together with a data dictionary, will be available upon reasonable request, subject to a data sharing agreement and ethics approval.
Supporting information: Study protocol, Statistical analysis plan
Time frame: After publication of the primary study results.
Access criteria: Researchers may request access for scientifically sound research proposals. Access is subject to review, a data sharing agreement, and ethics approval.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jun 2029, 30 months later.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 30 months is close to that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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 not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Guangdong Second Provincial General Hospital