Thrombolysis and RIPC in Acute Ischemic Stroke (tripcais)
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|ClinicalTrials.gov Identifier: NCT03218293|
Recruitment Status : Completed
First Posted : July 14, 2017
Last Update Posted : August 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke, Cerebral Embolism and Thrombosis||Device: RIPC device (IPC-906X)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Recovery of Nerve Function Deficient of Combined Intravenous Thrombolysis and Remote Ischemic Post-conditioning in Acute Ischemic Stroke.|
|Actual Study Start Date :||August 1, 2017|
|Actual Primary Completion Date :||October 31, 2020|
|Actual Study Completion Date :||October 31, 2020|
Remote ischemic postconditioning（RIPC）：Patients in the RIPC group not only receive foundational treatment but also have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm using a RIPC device (IPC-906X; Beijing Renqiao Institute of Neuroscience, Beijing, China) after thrombolysis while in-hospital.
Device: RIPC device (IPC-906X)
Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after thrombolysis.
Other Name: Thrombolysis
No Intervention: Blank control group(BC)
Blank control group:Patients in the BC group only receive foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin, 100-300 mg/d) and lipid-lowering (atorvastatin, 20 mg/d) drugs,throughout the 14 days in-hospital period without remote ischemic postconditioning after thrombolysis.
- the percentage of patients with a favorable outcome, defined as a score of 0 or 1 on the modified Rankin scale (mRS). [ Time Frame: Day 90 ]
- the percentage of functional recovery at discharge and at day 90, as measured by the NIHSS, the Barthel index (BI) and the mRS [ Time Frame: Day 90 and at discharge(up to day 14) ]we measured how many patients achieved a score of 0 or 1 for the NIHSS, 95 for the BI, and 0 - 2 for the mRS.
- Plasma biomarker concentrations [ Time Frame: Day 1 and at discharge ( up to day 14) ]Venous blood was drawn before the administration of IV tPA and at the end of hospitalization to determine the effect of repeated RIPC on anti-inflammatory (S100-β), vascular (VEGF, bFGF), anti-edema (MMP9), anti-oxidants (OH1) and other pathways (BDNF, HSP).
- mortality rate [ Time Frame: up to 3 months. ]three-month mortality rate
- the rate of symptomatic hemorrhagic transformation [ Time Frame: up to 36 hours ]Defined by European Cooperative Acute Stroke Study III classification
- Early neurological deterioration [ Time Frame: up to 24 hours after IV tPA ]
- The tolerance index [ Time Frame: up to 14 days ]the proportion of patients that could complete every RIPC treatment session during his/her hospital stay.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218293
|The First Affiliated Hospital of Xi'an Jiaotong University|
|Xi'an, China, 710061|
|Principal Investigator:||Guogang Luo, MD, PHD||First Affiliated Hospital Xi'an Jiaotong University|