Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke: Research Findings
A recent report published in the Stroke; a Journal of Cerebral Circulation discusses the results of a randomized, multicenter trial examining the feasibility and safety of hypothermia and intravenous tissue plasminogen activator in patients treated within 6 hours after ischemic stroke. The study, known as Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke (ICTuS-L), aimed to evaluate the efficacy of therapeutic hypothermia for acute stroke. The researchers concluded that a definitive efficacy trial is necessary to evaluate the efficacy of therapeutic hypothermia for acute stroke.
Key Takeaways:
- The study, ICTuS-L, was a randomized, multicenter trial of hypothermia and intravenous tissue plasminogen activator in patients treated within 6 hours after ischemic stroke.
- Enrollment was stratified to the treatment time windows 0 to 3 and 3 to 6 hours, with a total of 59 patients enrolled.
- Baseline demographics and risk factors were similar between groups, with a mean age of 65.5 years and a baseline National Institutes of Health Stroke Scale score of 14.0.
- Cooling was achieved in all patients except 2, with a median time to target temperature after catheter placement of 67 minutes.
- At 3 months, 18% of patients treated with hypothermia had a modified Rankin Scale score of 0 or 1 versus 24% in the normothermia groups (nonsignificant).
- Symptomatic intracranial hemorrhage occurred in 4 patients (68), all of whom were treated with tissue plasminogen activator.
- The researchers concluded that a definitive efficacy trial is necessary to evaluate the efficacy of therapeutic hypothermia for acute stroke.
Statistics:
- Mean age of patients treated with hypothermia: 65.5 years
- Mean baseline National Institutes of Health Stroke Scale score: 14.0
- Time to target temperature after catheter placement: 67 minutes (Quartile 1 57.3 to Quartile 3 99.4)
- Symptomatic intracranial hemorrhage rate: 68% (4 patients)
- Modified Rankin Scale score of 0 or 1 at 3 months: 18% (hypothermia group)
- Modified Rankin Scale score of 0 or 1 at 3 months (normothermia group): 24%
Sources:
- Hemmen, T.M., et al. "Intravenous thrombolysis plus hypothermia for acute treatment of ischemic stroke (ICTuS-L): final results." Stroke; a Journal of Cerebral Circulation, vol. 41, no. 10, 2010, pp. 2265-2270.
- Clinical Trials Week, "Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke," NewsRx.com, 2010.