Role of Hypothermia in Endovascular Stroke Thrombectomy | NCT06109376

Studies
Role of Hypothermia in Endovascular Stroke Thrombectomy

NCT06109376

Sponsor

Xinqiao Hospital of Chongqing

Status

Not yet recruiting

Last Update Posted

Oct 31, 2023Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Stroke, Acute Ischemic

Interventions

hypothermia
thrombectomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Mar 31, 2027Estimated

First Submitted Date

Oct 22, 2023

First Submission Date that Met QC Criteria

Oct 25, 2023

First Posted Date

Oct 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2023

Last Update Posted Date

Oct 31, 2023Actual

Name	Class
Xiangtan Central Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypothermia	Experimental	Patients in Hypothermia group received hypothermia combined with endovascular thrombectomy.	Procedure: hypothermia Procedure: thrombectomy
Control	Active Comparator	Patients in Control group received endovascular thrombectomy alone.	Procedure: thrombectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hypothermia	Procedure	In this trial, intra-arterial select cooling infusion is used to reduce brain tissue temperature to 33-35°C.	Hypothermia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	90 days post-randomization

Secondary Outcomes

Measure	Description	Time Frame
Excellent outcome	Score of 0-1 on the modified Rankin scale	90 days post-randomization
Functional independence	Score of 0-2 on the modified Rankin scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;
Baseline ASPECTS score ≥ 3 and ≤8, or cerebral infarction core volume < 100ml;
The patient decides to undergo endovascular therapy;
The patient or patient's representative signs a written informed consent form.

Exclusion Criteria:

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;
Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
Intracranial aneurysm, arteriovenous malformation;
Any terminal illness with life expectancy less than 6 months;
Participating in other clinical trials.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Guangxiong Yuan, M.S.	Contact	18973223018		yuanguangxiong74@163.com

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, and Analytic Code will be shared after approval of a proposal from principal investigator 3 years after the trial results are revealed.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

3 years after the trial results are revealed.

Access Criteria

after approval of a proposal from principal investigator

URL

Not provided

ID	Term
D000083242	Ischemic Stroke
D007035	Hypothermia

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative