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Changhai multi-modal brain reperfusion platform for acute ischemic stroke

Changhai multi-modal reperfusion therapy for acute ischemic stroke registry

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-14005256
Enrollment
Unknown
Registered
2014-08-27
Start date
2014-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

acute ischemic stroke

Interventions

Sponsors

Cerebrovascular disease center of Changhai
Lead Sponsor

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: intravenous thrombolysis group 1.the treatment could be initiated within 4.5 hours after stroke onset; 2.the candidate should be older than 18 years old and not beyond the birthday of 81 years if administration is started between 3 and 4.5 hours after stroke onset; 3.the existence of any neorological signs that suspected to be acute ischemic stroke. mechanical reperfusion group 1.aged between 18-80 years (i.e. the candidates must not have had their 81th birthday); 2.treatment could be started within 8 hours after onset, or 12 hours for posterior circulation.

Exclusion criteria

Exclusion criteria: intravenous thrombolysis 1.Significant head trauma or prior stroke in previous 3 months; 2.Symptoms suggest subarachnoid hemorrhage; 3.Arterial puncture at noncompressible site in previous 7 days; 4.History of previous intracranial hemorrhage; 5.Intracranial neoplasm, arteriovenous malformation, or aneurysm; 6.Recent intracranial or intraspinal surgery; 7.Elevated blood pressure (systolic higher than 185 mm Hg or diastolic higher than 110 mm Hg); 8.Active internal bleeding; 9.Acute bleeding diathesis; 10.Platelet count less than 100 000/mm3; 11.Heparin received within 48 hours, resulting in abnormally elevated aPTT greater than the upper limit of normal; 12.Current use of anticoagulant with INR more than 1.7 or PT more than 15 seconds; 13.Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (such as aPTT, INR, platelet count, and ECT; TT; or appropriate factor Xa activity assays) 14.Blood glucose concentration less than 50 mg/dL (2.7 mmol/L); 15.CT demonstrates multilobar infarction (hypodensity more than 1/3 cerebral hemisphere); endovascular treatment 1.History stroke or head trauma in the past 3 months; 2.Intracranial neoplasm, arteriovenous malformation or aneurysms; 3.Previous intracranial hemorrhage; 4.Cranial CT reveal hypodensity area larger than 1/3 middle cerebral artery area; 5.Hypertension at the time of treatment; systolic blood pressure (BP) higher than 185 or diastolic pressure higher than 110 mmHg; or aggressive measures to lower BP to below these limits are needed; 6.Any active or recent (within 30 days) hemorrhage; 7.Recent (within 30 days) surgery or biopsy of parenchymal organ; 8.Known coagulation factor deficiency, or oral anticoagulant therapy with INR more than 1.7 or institutionally equivalent prothrombin time longer than 15 seconds; 9.Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission; 10.Baseline lab values: glucose less than 50mg/dl, platelets less than 100 000, or Hct more than 25; 11.Patients who require hemodialysis or peritoneal dialysis; 12.Patients who have received heparin within 48 h must have a normal partial thromboplastin time to be eligible; 13.Subjects with an arterial puncture at a noncompressible site or a lumbar puncture in the previous 7 days 14.Patients with a seizure at the onset of stroke; 15.Other serious, advanced, or terminal illness.

Design outcomes

Primary

MeasureTime frame
favorable outcome;neurological improvement within 24 hours;rate of symptomatic intracranial hemorrhage;

Secondary

MeasureTime frame
infarction volume;neurological deterioration other than intracranial;

Countries

China

Contacts

Public ContactJianmin LIU
liu118@vip.163.com+86 13901780638

Outcome results

None listed

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