Multicenter Trial of Hemodilution in Ischemic Stroke "SSS"

Completed

Phase 3 Results

Trial Description

To evaluate the effect of early hemodilution treatment by a combination of venesection and dextran 40 administration on clinical outcome.

Interventions

  • Hemodilution Procedure/Surgery
    Intervention Desc: Decreased viscosity may increase cerebral blood flow or oxygen delivery
  • Dextran Drug
    Intervention Desc: Dextran is used as a volume expander.

Trial Design

Prospective, controlled trial of 370 patients at 15 Scandinavian centers.

Patient Involvement

Patients were randomized to treatment group or placebo and treatment was initiated immediately after randomization. If hematocrit was 38.0-41.9%, a 250 ml venesection was performed. If hematocrit was 42.0-50.0%, a 500 ml venesection was performed. The blood drained during venesection was replaced by the same volume of dextran 40 in saline. Day 2 treatment was the same unless hematocrit was <38% in which case no venesection was done and 500 ml dextran was infused (in 2-4 hours) daily on days 3-5 to maintain hemodilution .

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional score at day 1 and 6 and 3 months after stroke. Also ADL performance as measured on day 6 and 3 months by the Barthel score.

Sponsors

Pharmacia Infusion