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Role of Hypothermia in Endovascular Stroke Thrombectomy

ConditionStroke, Acute Ischemic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXinqiao Hospital of Chongqing

About this trial

Reducing or suspending the increase of the infarcted core, i.e., "freezing" the ischemic penumbra, may help improve the efficacy of mechanical thrombectomy. Hypothermia effectively reduces the metabolic level of brain tissue, may prolong the time window for recanalization therapy, and its multi-target therapeutic effect make it one of the most promising neuro-protection approach.

In recent years, hypothermia has been increasingly used to treat acute ischemic stroke. However, its role in acute ischemic stroke is unclear.

The objective of this trial is to investigate whether hypothermia combined with endovascular thrombectomy could add additional benefit without increasing the risk of adverse events such as pneumonia, intracerebral hemorrhage, and mortality.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥ 18 years or more;

acute ischemic stroke within 24 hours from onset to randomization;

NIHSS ≥6 points before randomization;

Internal carotid artery, or the middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA/DSA;

Disqualifiers

CT or MR evidence of hemorrhage;

Currently pregnant or lactating (women patients);

Allergy to radiographic contrast agents, or nitinol devices;

Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;

Trial design

Design model

Parallel

Treatments tested in this trial

  • hypothermia

    Procedure/Surgery

    In this trial, intra-arterial select cooling infusion is used to reduce brain tissue temperature to 33-35°C.

  • thrombectomy

    Procedure/Surgery

    Thrombectomy includes treatment with stent retrievers and/or thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: HypothermiaExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified Rankin scale score (mRS)

Modified Rankin scale score (mRS): scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death

Time frame
90 days post-randomization

Secondary outcomes

1

Excellent outcome

Score of 0-1 on the modified Rankin scale

Time frame
90 days post-randomization
2

Functional independence

Score of 0-2 on the modified Rankin scale

Time frame
90 days post-randomization
3

Moderate outcome

Score of 0-3 on the modified Rankin scale

Time frame
90 days post-randomization
4

Early neurological improvement

Compared with baseline NIHSS, the 72h NIHSS score is reduced by 8 points or more, or the 72h NIHSS is 0\~1 point

Time frame
72 hours post-randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xinqiao Hospital of Chongqing

Lead sponsor

Xiangtan Central Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: