A double-blind trial of Dextran-haemodilution vs. placebo in claudicants

Area of Science:

• Vascular Medicine
• Hematology

Background:

• Peripheral arterial disease (PAD) management often lacks robust evidence for treatments like hemodilution.
• Intermittent claudication significantly impacts patient quality of life.

Purpose of the Study:

• To evaluate the clinical efficacy and safety of Dextran-haemodilution in patients with intermittent claudication due to PAD.
• To assess the impact of Dextran-haemodilution on walking capacity and hemorheological parameters.

Main Methods:

• A randomized, placebo-controlled crossover study involving 20 patients with PAD and intermittent claudication.
• Isovolumetric hemodilution with Dextran 40 (500 ml) was administered over 3 weeks, followed by a washout and placebo period (and vice versa).
• Standardized treadmill tests, plethysmography, Doppler pressures, hematocrit, blood/plasma viscosity, and fibrinogen levels were measured.

Main Results:

• Dextran-haemodilution led to a significant 50% increase in both pain-free and maximal walking distances.
• This improvement was associated with a significant reduction in hematocrit and blood viscosity.
• No significant changes were observed during the placebo treatment, and the intervention was well-tolerated.

Conclusions:

• Dextran-haemodilution is a safe and effective treatment for selected patients with peripheral occlusive arterial disease (POAD) experiencing intermittent claudication.
• Angiographic assessment may help identify potential responders prior to therapy.
• The efficacy of Dextran 40 is comparable to other agents like hydroxyethyl starch.