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Intra-arteria local therapeutic hypothermia in patients with acute anterior circulation large vessel occlusion treated with endovascular reperfusion (ISOLATION) an open label multi-center randomized pilot trial

Intra-arteria local therapeutic hypothermia in patients with acute anterior circulation large vessel occlusion treated with endovascular reperfusion (ISOLATION) an open label multi-center randomized pilot trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074990
Enrollment
Unknown
Registered
2023-08-22
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

Acute anterior circulation large vessel occlusion

Interventions

treatment group:In the treatment group, the microcatheter was first used to cross the occlusion vascular segment. After the angiography indicated that it was located in the true cavity, the normal sal
control group:Patients in the control group were treated with a similar procedure in the treatment group, instead of using 4-degree normal saline, they were treated with 15-20 degree normal saline at

Sponsors

The Second People's Hospital of Guangdong Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Age =18 and =80 years old 2) Inclusion criteria: (1) Sudden focal or general neurological deficits (2) Acute internal carotid artery terminal and/or middle cerebral artery M1 occlusion confirmed by magnetic resonance angiography or CT angiography (3) There may be a causal relationship between vascular occlusion and nerve function deficit. (4) Within 6 hours from the onset of clinical symptoms to the expected time of puncture, or within 16 hours from the expected time of puncture and meeting the imaging standards of DAWN and DEFUSE3, or 24 hours from the expected time of puncture and meeting the imaging standards of DAWN. (5) According to the judgment of the clinician, the operation path is reasonable, and the surgery and operation-related instruments can reach the disease smoothly (6) Patients or their guardians can understand the purpose of the trial, voluntarily participate in and sign a written informed consent, and have the ability to receive clinical follow-up

Exclusion criteria

Exclusion criteria: (1) Pre-onset MRS=1 score (2) There were acute infarcts in both cerebral hemispheres (3) NIHSS=6 points (4) Cerebral hemorrhage/subarachnoid hemorrhage was confirmed by CT or Mr (5) There is active bleeding, severe anemia, coagulation dysfunction, or do not receive necessary blood transfusion treatment. (Presence of at least one of the following laboratory tests: hemoglobin 1.5, PT> 1 minute above the upper limit of normal, or heparin-related thrombocytopenia) (6) Serious heart, liver and kidney diseases (7) With malignant diseases such as malignant tumors, the expected survival time is less than 3 months (8) Participating in other clinical trials, in the research stage or follow-up stage

Design outcomes

Primary

MeasureTime frame
modified Rankin score (mRs ) at 90 days;

Secondary

MeasureTime frame
the rate of successful recanalization;Cerebral infarction volume was measured by CT or magnetic resonance DWI 72 hours to 7 days after EVT;The incidence of reocclusion by MRI or CT angiography 72 hours to 7 days after EVT;Early neurological function changes within 72 hours after EVT;Degree of perioperative rectal temperature change;Operating time;Mean change in NIHSS score from baseline after treatment;Mean change in mRS Scores from baseline after treatment;Incidence of symptomatic intracranial hemorrhage within 72 hours afterEVT;Incidence of coagulation dysfunction within 72 hours after EVT;Incidence of post-stroke pneumonia;Incidence of perioperative new bradycardia;

Countries

China

Contacts

Public ContactHuang Zhixin

Department of Neurology, Second People's Hospital of Guangdong Province

zx-huang@163.com+86 188 9854 6655

Outcome results

None listed

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