Prospective Randomized Controlled Trial on the Safety and Neuroprotective Efficacy of Remote Administration of Hypothermia (RAH) in the Spleen during Acute Ischemic Stroke with Mechanical Thrombectomy: Rationale, Design, and Protocol

Prospective Randomized Controlled Trial on the Safety and Neuroprotective Efficacy of Remote Administration of Hypothermia (RAH) in the Spleen during Acute Ischemic Stroke with Mechanical Thrombectomy

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300077052

Enrollment

Unknown

Registered

2023-10-27

Start date

2023-11-01

Completion date

Unknown

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

Splenic hypothermia group:Patients will be initiated with RAH prior to recanalization until 6 hours after thrombectomy. RAH is achieved by applying ice packs to the spleen area (left side of the abdom

Control group:Patients in the control group will apply packs at room temperature in the left abdomen until 6 hours after thrombectomy

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age of 18-80 years; (2) Patients with AIS; (3) LVO of the anterior circulation confirmed by computer tomography angiography (CTA), magnetic resonance angiography (MRI), or digital subtraction angiography (DSA); (4) Baseline National Institute of Health stroke scale (NIHSS) score =6 and Alberta Stroke Program Early CT Score (ASPECTS) score >5; (5) Less than 24 hours from stroke onset; (6) Acute occlusion of intracranial or extracranial segments of the anterior circulation vessels (thrombolysis in cerebral infarction score [TICI] classification 0-I); (7) Informed consent of the participant or legally authorized representative.

Exclusion criteria

Exclusion criteria: (1) Spontaneous revascularization or rapid spontaneous improvement in neurological function (NIHSS2; (6) Blood glucose 22.2 mmol/L; (7) Laboratory evidence of coagulation dysfunction (platelet count 50 seconds, or INR >3.0); (8) Pregnancy; (9) Splenic-related hematologic disorders, hypersplenism or suppression; (10) Hypothermia or hypersensitivity of the skin, such as cold urticaria; (11) Obesity of patients (BMI =28/waist circumference >90 cm); (12) Abdominal injury, surgical trauma and other factors intolerance to splenic hypothermia; (13) Patients enrolled within 3 months prior to this clinical trial or already enrolled in another clinical trial; (14) Failure to obtain informed consent; (15) Splenectomy patients.

Design outcomes

Primary

Measure	Time frame
any adverse events related to RAH;	—

Secondary

Measure	Time frame
spleen volume measurement; infarct volume;Intracranial hemorrhage;neurological functional independence evaluation at 90-days;Other adverse events during hospitalization;	—

Countries

China

Contacts

Public ContactGeng Xiaokun

Beijing Luhe Hospital, Capital Medical University

xgeng@ccmu.edu.cn+86 183 1105 5270

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026