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Clinical study on the efficacy and safety of intravascular temperature control system

Clinical study on the efficacy and safety of intravascular temperature control system

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091034
Enrollment
Unknown
Registered
2024-10-18
Start date
2024-10-21
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Diseases requiring adjuvant treatment with temperature control

Interventions

Test group:Intravascular temperature control system adjuvant therapy

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with acute ischemic stroke meet the following conditions: 1) Age =18 years old; 2) Anterior circulation vessel occlusion confirmed by CTA/MRA/DSA (ICA, MCA M1 or M2 segment); 3) NCCT/MRI-DWI ASPECTS score 3-5 or CTP core infarction volume (rCBF <30%) 50-150ml; 4) eTICI= 2B 50 after EVT treatment; 5) NIHSS score =10 before EVT treatment. 2. Patients with subarachnoid hemorrhage meet the following conditions: 1) Age =18 years old; 2) CT confirmed subarachnoid hemorrhage; 3) mFisher grade 2-4; 4) WFNS grade II-V. 3, patients with cerebral hemorrhage, meet the following conditions: 1) Age =18 years old; 2) CT confirmed cerebral hemorrhage, acute (within 72 hours) or subacute (3 days to 3 weeks); 3) Glasgow Coma Scale (GCS) < 15 points. 4. Patients with perioperative temperature control shall meet the following conditions: 1) Age =18 years old; 2) General anesthesia or combined anesthesia; 3) The duration of anesthesia is expected to exceed 2 hours.

Exclusion criteria

Exclusion criteria: 1) Serious infectious diseases, serious coagulopathy, suffering from serious heart, lung and other diseases; 2) Infection in the puncture areaabnormal anatomy of the puncture site; 3) Allergic to heat exchange catheters; 4) Serious hepatic and renal insufficiency; 5) Pregnant and lactating women and those who plan to get pregnant within one year; 6) Participants who participated in clinical trials of any drug and/or medical device within 3 months prior to enrollment; 7) The researcher considers that there are any other factors that are not suitable for inclusion or affect the participant's participation in the study.

Design outcomes

Primary

MeasureTime frame
Success rate of target temperature management;

Secondary

MeasureTime frame
Successful cooling rate;Mean hourly cooling temperature(min);Mean cooling time;Stably maintain the target temperature duration;Target temperature maximum deviation value;Target temperature mean deviation value;Successful warming rate;Mean hourly warming temperature (min);Mean warming time;Device Success rate;Device operating performance evaluation;Incidence of complications;The incidence of adverse events;

Countries

China

Contacts

Public ContactLiqun Jiao

Xuanwu Hospital of Capital Medical University

liqunjiao@sina.cn+86 139 1122 4991

Outcome results

None listed

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