Stroke Unit Versus General Medical Wards II

Completed

Phase N/A Results

Trial Description

To assess whether acute treatment in a stroke unit (SU) with a short length of stay is effective in improving outcome 7 months after stroke compared with treatment in a general medical ward (GMW) and to identify the extent to which individual treatment differs between an SU and a GMW.

Interventions

Trial Design

Quasi-randomized (randomization by date of birth in month), controlled trial of 550 patients at a single center.

Patient Involvement

Patients were randomized to receive care in a stroke unit (SU) or in a general medical ward (GMW). Medical treatment in the SU followed current practice guidelines for the management of patients with acute stroke which included immediate administration of aspirin if ischemic stroke was suspected after clinical and CT evaluation, mobilization of all patients as early as possible, administration of parenteral isoosmolar fluid for the first 24 hours, treatment of hyperglycemia with insulin, treatment of fever with antipyretics, administration of low-molecular-weight heparin for immobilized patients, anticoagulation if cardioembolic stroke suspected, and physiotherapy using Bobath technique. In the SU, treatment was multidisciplinary, coordinated and included patients' relatives. Patients randomized to GMW received care in one of five wards depending on capacity. These patients were given traditional, good medical treatment without special efforts or standardized effort toward this patient group. Care in the GMW differed from the SU in that mobilization was discouraged until hemorrhage was excluded by CT scan and there was no routine use of antipyretics or parenteral isoosmolar fluids. After acute medical treatment, stabilization and early rehabilitation for approximately one week, patients in both groups were discharged either home, to nursing homes, to community-based long-term rehabilitation, or to hospital-based long-term rehabilitation. Patients were followed from entry to the study until August 1, 1996 (213 to 884 days). Follow-up included assessments at day 1, day 5 and after 7 months by the primary investigator.

Outcomes

Type Measure Time Frame Safety Issue
Primary Death, need for long-term care, and number of patients who improved, deteriorated, or died after 7 months.
Secondary Difference in change in neurological impairment as assessed by the Scandinavian Stroke Scale (SSS) at admission, the day after admission, the fourth or fifth day and after 7 months. Difference in change in functional disability as assessed by the Barthel Index the day after admission, the fourth or fifth day and after 7 months.

Sponsors

National Association for Heart and Vascular Diseases.