Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke

NCT05779176 | Unknown DMC

• 1 other identifier: RA-2022-180
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

Therapeutic hypothermia (TH) in stroke has demonstrated robust neuroprotection in animals especially after ischemia-reperfusion injury, but its safety and efficacy remain controversial. The investigators propose this trial to study the clinical and radiological effects of therapeutic hypothermia in acute ischemic stroke patients treated with intravascular thrombectomy (IVT).

Conditions

Stroke, Ischemic

Keywords

Therapeutic hypothermia, AIS, Neurological function prognosis

Outcome Measures

Primary Outcomes (1)

• Neurological function prognosis

  the score on the modified Rankin Scale, seven grades ranked from 0 to 6, higher scores mean worse outcome

  90±14 days post-operation

Secondary Outcomes (8)

• Ratio of mRS score 2 or less

  90±14 days post-operation

• Incidence of intracranial hemorrhage and symptomatic intracranial hemorrhage

  24-72 hours post-operation

• Target vascular recanalization rate

  24-72 hours post-operation

• NIHSS score

  7 days post-operation

• Final infarct volume

  7 days post-operation

Study Arms (2)

Normothermia arm

NO INTERVENTION

Patients randomized to normothermia will be maintained at 36-37°C during the entire study period.

Therapeutic hypothermia arm

EXPERIMENTAL

Patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C

Procedure: Therapeutic hypothermia

Interventions

Therapeutic hypothermia PROCEDURE

The study intervention is therapeutic hypothermia. After intubation, patients assigned to therapeutic hypothermia will receive central venous catheterization through right jugular vein or femoral vein depending on the cooling application and the unique needs, a flexible catheter will be inserted and iced saline was circulated through the multiple balloons of the catheter in a closed-loop design to induce therapeutic hypothermia. This system also has a hydrophilic coating with heparin and a triple-lumen central venous catheter to satisfy the need of fluid or drug infusion, blood draw and central venous pressure monitoring. After central venous catheterization, patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C.

Therapeutic hypothermia arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-85 years(inclusive);
• Patients have clinical signs consistent with acute ischemic stroke,
• Patients with acute large vessel occlusion including internal carotid artery and middle cerebral artery M1 and M2 demonstrated by CTA，MRA or DSA
• The possibility to receive arterial thrombus removal treatment （within6 or24 hr of large vessel occlusion ）;
• Provide the informed consent form of the patient or the patient's agent.

You may not qualify if:

• Coma or altered vigilance defined as a score ≥2 on the level of consciousness 1A subscale of the NIHSS.
• Associated cerebral hemorrhage.
• There is dysfunction before the onset, mRS score \>= 2 points;
• Accompanied by severe comorbidities (such as severe cardiopulmonary insufficiency, the expected survival period of advanced malignant tumors is less than 90 days);
• Multi-mode CT/MRI examination of the corresponding contrast agent use contraindications (such as contrast agent allergy, etc.);
• Women during pregnancy or lactation;
• Patients currently participating in other clinical research trials;

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, 200127, China

Location

Related Publications (6)

• Mendelson SJ, Prabhakaran S. Diagnosis and Management of Transient Ischemic Attack and Acute Ischemic Stroke: A Review. JAMA. 2021 Mar 16;325(11):1088-1098. doi: 10.1001/jama.2020.26867.

  PMID: 33724327 BACKGROUND

• Feigin VL, Norrving B, Mensah GA. Global Burden of Stroke. Circ Res. 2017 Feb 3;120(3):439-448. doi: 10.1161/CIRCRESAHA.116.308413.

  PMID: 28154096 BACKGROUND

• Chio CC, Kuo JR, Hsiao SH, Chang CP, Lin MT. Effect of brain cooling on brain ischemia and damage markers after fluid percussion brain injury in rats. Shock. 2007 Sep;28(3):284-90. doi: 10.1097/SHK.0b013e3180311e60.

  PMID: 17529907 BACKGROUND

• Hynson JM, Sessler DI, Moayeri A, McGuire J. Absence of nonshivering thermogenesis in anesthetized adult humans. Anesthesiology. 1993 Oct;79(4):695-703. doi: 10.1097/00000542-199310000-00010.

  PMID: 8214747 BACKGROUND

• Gluckman PD, Wyatt JS, Azzopardi D, Ballard R, Edwards AD, Ferriero DM, Polin RA, Robertson CM, Thoresen M, Whitelaw A, Gunn AJ. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial. Lancet. 2005 Feb 19-25;365(9460):663-70. doi: 10.1016/S0140-6736(05)17946-X.

  PMID: 15721471 BACKGROUND

• Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.

  PMID: 11856793 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics

Study Officials

• Liqun Yang, Ph.D.

  Renji Hospital, Shanghai Jiao Tong University School of Moedicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liqun Yang, Ph.D.

CONTACT

+8615921969001; lqyang72721@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This trial is open labeled, the treatment allocation is known to the treating physicians and the patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: archiater

Model Details: Safety and efficacy of therapeutic hypothermia in acute ischemic stroke (AIS) patients treated with Intravascular thrombectomy is a prospective, multi-center, randomized, parallel-group interventional study.

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 22, 2023
• Study Start: May 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: October 31, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

CN (1)