Telemedicine consultation provided treatment options not previously available at the remote hospital. Administration of rtPA during telemedicine consultation was feasible and safe, and the system was well received. Lack of reimbursement for telemedicine services will hinder widespread adaptation of this promising technology for remote acute stroke treatment.
Background and Purpose
HeADDFIRST was a randomized pilot study to obtain information necessary to design a Phase III trial to evaluate the benefit of surgical decompression for brain swelling from large supratentorial cerebral hemispheric infarction (LSCHI).
Methods
All stroke patients were screened for eligibility [age 18–75, NIHSS ≥ 18 with Item 1a < 2 (responsive to minor stimulation), and CT demonstrating unilateral, complete MCA territory infarction by specific imaging criteria]. All enrolled patients were treated using a standardized medical treatment protocol. Those with both ≥ 4 mm of pineal shift and deterioration in level of arousal or ≥ 7.5 mm of anteroseptal shift within 96 hours of stroke onset were randomized to continued Medical Treatment Only (MTO) or Medical Treatment plus Surgery (MTS). Death at 21 days was the primary outcome measure.
Results
Among 4,909 screened patients, only 66 (1.3%) were eligible for HeADDFIRST. Forty patients were enrolled, and 26 developed the requisite brain swelling for randomization. All who failed to meet randomization criteria were alive at 21 days. Mortality at 21 and 180 days was 40% (4/10) in the MTO and 21% (3/14) and 36% (5/14) in the MTS arms, respectively.
Conclusions
HeADDFIRST randomization criteria effectively distinguished low from high risk of death from LSCHI. Lower mortality in the MTO group than in other published trials suggests a possible benefit to standardizing medical management. These results can inform the interpretation of recently completed European trials regarding patient selection and medical management.
In this first North American randomized, double-blinded, placebo-controlled study of direct thrombin inhibition in acute ischemic stroke, argatroban at each dose evaluated significantly prolonged aPTTs without increasing ICH or major bleeding. These results suggest that argatroban provides safe anticoagulation in acute ischemic stroke, warranting future studies powered to evaluate its efficacy and more precisely estimate event rates.
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