A randomized, double blind, placebo-controlled, cross-over trial on isovolemic hemodilution in claudicants – preliminary results

Article type: Research Article

Authors: Ernst, E.^a | Matrai, A.^a | Kollar, L.^b

Affiliations: [a] Klinik für Physikalische Medizin der Universität München, Ziemssenstr. 1,8000 München 2, FRG | [b] T. Sz. Sebészeti Klinika, Pécsi Orvostudomanyi Egyetem

Note: [] Accepted by: Guest Editor G. Lenti

Abstract: Presently the clinical efficacy of hemodilution in peripheral vascular disease is only supported by uncontrolled trials. This is a preliminary report about results obtained in a randomized placebo-controlled, double blind, cross-over study. Fourteen male patients with stable intermittant claudication, hematocrit higher than 45%, walking distance between 200 and 300 m and subtotal stenosis or obstruction of a femoral artery with good collateralization were admitted. Isovolemic hemodilution was performed three times per week with 500 ml of 10% hydroxyethyl starch (200) for three weeks. This was followed by a “wash-out” period of two weeks. Finally a three weeks’ period of regular “sham” dilutions was introduced, which for the patient appeared identical to hemodilutions, but where no blood was exchanged. This regim was randomly executed for- or backwards. To keep double blind standards, clinical assessment of the patients (maximal walking distance on a treadmill and plethysmogram) was done by a third party and hemorheological measurements (blood viscosity and hematocrit) by a forth party. Results show that “sham” dilutions did not induce any positive changes, while hemodilution resulted in a significant fall of hematocrit and blood viscosity paralleled by a significant rise in walking distance and resting blood flow.

Keywords: hemodilution, peripheral vascular disease

DOI: 10.3233/CH-1986-6403

Journal: Clinical Hemorheology and Microcirculation, vol. 6, no. 4, pp. 297-301, 1986