Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window

Wuhan General Hospital of Guangzhou Military Command

Status: Unknown

Conditions: Stroke

Treatments: Drug: IV rt-PA

Study type: Observational

Funder types: Other

Identifiers

NCT01770197

20090101

Details and patient eligibility

About

The time window for intravenous recombinant tissue plasminogen activator treatment in ischemic stroke patients has been extended to 4.5h. Little is known about intravenous recombinant tissue plasminogen activator use in the 3-4.5 hour time window among Chinese stroke patients. This exploratory study was to describe the feasibility and outcome of treatment with intravenous recombinant tissue plasminogen activator in the expanded time window, and to offer suggestions for future clinical work in China.

Full description

Favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the National Institute of Health Stroke Scale score at 24 hours and by the improvement of modified Rankin Scale score at discharge or 6-month follow-up. The safety of intravenous recombinant tissue plasminogen activator was assessed by the rate of mortality, intracerebral hemorrhage and other common complications. Multivariate logistic regression models were used to evaluate factors associated with favorable clinical outcome.

Enrollment: 200 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:stroke patients in the 3-4.5 hour time window -

Exclusion Criteria:stroke patients in more than 4.5 hour time window

Trial design

200 participants in 2 patient groups

recombinant tissue plasminogen activator

Description:

Stroke patients with rt-PA treatment in the 3-4.5 hour time window were compared with those within 3h.

Treatment:

Drug: IV rt-PA

rt-PA

Description:

One group of was treated with standard recombinant tissue plasminogen activator therapy in 3h and the other group of stroke patients was treated within 3-4.5h.

Treatment:

Drug: IV rt-PA