Status:
COMPLETED
Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke
Lead Sponsor:
Yi Yang
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.
Detailed Description
In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning f...
Eligibility Criteria
Inclusion
- 1\) Age≥18 years, \< 80 years, regardless of sex;
- 2\) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
- 3\) Baseline NIHSS \>= 5, and \<= 25;
- 4\) Baseline GCS ≥8;
- 5\) Signed and dated informed consent is obtained
Exclusion
- 1\) Patients who undergo endovascular treatment;
- 2\) mRS ≥ 2 before the onset of the disease;
- 3\) Double upper limbs or lower limbs paralysis was found in this case;
- 4\) Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
- 5\) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
- 6\) Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
- 7\) Severe organ dysfunction or failure;
- 8\) Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
- 9\) Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
- 10\) Those who have a history of atrial fibrillation;
- 11\) The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb#Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
- 12\) Pregnant or lactating women;
- 13\) Previous remote ischemic conditioning therapy or similar treatment;
- 14\) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
- 15\) Severe hepatic and renal dysfunction;
- 16\) Unwilling to be followed up or treated for poor compliance;
- 17\) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;
- 18\) Other conditions that the researchers think are not suitable for the group.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04027621
Start Date
July 1 2019
End Date
July 20 2020
Last Update
June 30 2022
Active Locations (1)
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1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000