A multicenter clinical study of the safety and activity of maleimide-polyethylene glycol-modified Hemoglobin (Hemospan) in patients undergoing major orthopedic surgery.

• BACKGROUND: Hemospan (Sangart Inc., San Diego, CA), a polyethylene glycol-modified hemoglobin with unique oxygen transport properties, has successfully completed a phase I trial in healthy volunteers. Because adverse events are expected to increase with age, the authors conducted a phase II safety study of Hemospan in elderly patients undergoing elective hip arthroplasty during spinal anesthesia. METHODS: Ninety male and female patients, American Society of Anesthesiologists physical status I-III, aged 50-89 yr, in six Swedish academic hospitals were randomly assigned to receive either 250 or 500 ml Hemospan or Ringer's acetate (30 patients/group) before induction of spinal anesthesia. Safety assessment included vital signs and Holter monitoring from infusion to 24 h, evaluation of laboratory values, and fluid balance. The hypothesis to be tested was that the incidence of adverse events would be no more frequent in patients who received Hemospan compared with standard of care (Ringer's acetate). RESULTS: Three serious adverse events were noted, none of which was deemed related to study treatment. Liver enzymes, amylase, and lipase increased transiently in patients in all three groups. There were no significant differences in electrocardiogram or Holter parameters, but there was a suggestion of more bradycardic events in the treated groups. Hypotension was less frequent in the treated patients compared with controls. CONCLUSIONS: In comparison with Ringer's acetate, Hemospan mildly elevates hepatic enzymes and lipase and is associated with less hypotension and more bradycardic events. The absence of a high frequency of serious adverse events suggests that further clinical trials should be undertaken.

Nyckelord

Aged

Aged

80 and over

Anesthesia

Spinal

Arthroplasty

Replacement

Hip

Blood Loss

Surgical

Blood Substitutes

adverse effects

therapeutic use

Blood Transfusion

Body Weight

physiology

Double-Blind Method

Electrocardiography

drug effects

Electrocardiography

Ambulatory

Enzymes

blood

Female

Hemoglobins

adverse effects

chemistry

therapeutic use

Humans

Isotonic Solutions

Male

Maleimides

adverse effects

therapeutic use

Middle Aged

Orthopedic Procedures

Polyethylene Glycols

adverse effects

therapeutic use

Water-Electrolyte Balance

physiology

MEDICINE

Publikations- och innehållstyp

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