A Multicenter, Randomized, Controlled Study of Rt-PA Thrombolysis Combined With Edaravone Dexborneol in Reducing Hemorrhagic Transformation in Patients With Acute Ischemic Stroke

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

In this study, a multicenter, randomized, controlled, prospective cohort study was conducted to observe the effect of Edaravone Dexborneol on the incidence and outcome of bleeding transformation after thrombolysis in acute ischemic stroke. To explore the methods to reduce the dilemma of bleeding transformation after thrombolysis, and to dynamically detect the changes of the main links causing bleeding transformation such as blood-brain barrier damage, local immune response activation and so on. To explore the mechanism of Edaravone Dexborneol in reducing bleeding transformation. It is proved that Edaravone Dexborneol combined with thrombolytic therapy can reduce the risk of bleeding and transformation after thrombolysis and improve the safety of thrombolysis. Secondly, it can improve the early recanalization rate of ischemic stroke patients after thrombolytic therapy, and effectively protect the integrity of the blood-brain barrier.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• All patients met the diagnostic criteria of the Chinese acute ischemic stroke diagnosis and treatment guidelines.

• Patients developed clinical symptoms for the first time, with an onset time of less than 4.5 hours.

• Patients with the National Institutes of Health Stroke Scale (NIHSS) neurological deficit score was ≥4.

• The study was approved by the hospital's theoretical committee and the patients provided consent.

Locations
Other Locations
China
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Contact Information
Primary
Guojun Tan, Dr
tandyshine@163.com
15803210587
Backup
Boxu Xie
xiebx1999@163.com
15383935253
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2024-06-30
Participants
Target number of participants: 400
Treatments
No_intervention: The control group
The control group received basic treatment following intravenous drip of rt-PA (specification: 50 mg), including statins and drugs that improve circulation.
Experimental: The edaravone dexborneol group
The edaravone dexborneol group received an injection of concentrated edaravone dexborneol solution (specifications: edaravone, 10 mg and dexborneol, 2.5 mg in a 5 mL solution) and 0.9% sodium chloride injection \[(100 mL), intravenous infusion twice per day, completed within 30 minutes\]. The time between the two doses was no less than 6 hours, and each cycle lasted 12 days.
Related Therapeutic Areas
Sponsors
Leads: The Second Hospital of Hebei Medical University

This content was sourced from clinicaltrials.gov