A clinical safety trial of stroma-free hemoglobin.
A stroma-free hemoglobin (SFH) solution was prepared which was sterile, pyrogen free, and contained only 1.2% of the stromal lipid present in unpurified hemolysate, 250 ml of which was administered slowly intravenously to 8 healthy men. Two control subjects received 250 ml of serum albumin. The SFH infusions were generally well tolerated by 7 of the 8 men. One subject developed abdominal pain and costovertebral angle tenderness after infusion, which disappeared within 48 hr. Bradycardia and a mild increase in blood pressure was present during ths SFH infusions and for 4 to 5 hr thereafter. A decrease in urine output and endogenous creatinine clearance appeared during the SFH infusions and for 2 to 4 hr after infusion. A mild prolongation of the activated partial thromboplastin time developed immediately after infusion. Gross hemoglobinuria appeared as expected during the SFH infusions and completely disappeared by 6 to 10 hr after infusion. All the cardiovascular, renal, and clotting changes were present for only a few hours after the SFH infusion, during the hemoglobinemia (free Hb in plasma). At 24 hr and 7 days after infusion all measurements were normal, and 6 mo follow-up showed no abnormalities or hepatitis.
D000293:Adolescent; D000328:Adult; D001777:Blood Coagulation / Q000187:drug effects; D001794:Blood Pressure / Q000187:drug effects; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D003404:Creatinine / Q000378:metabolism; D004231:Diuresis / Q000187:drug effects; D004340:Drug Contamination; D004341:Drug Evaluation; D004562:Electrocardiography; D004912:Erythrocytes; D006339:Heart Rate / Q000187:drug effects; D006454:Hemoglobins / Q000009:adverse effects*; D006456:Hemoglobinuria / Q000139:chemically induced; D006801:Humans; D008297:Male; D010952:Plasma Substitutes / Q000009:adverse effects*
D006454:Hemoglobins; D010952:Plasma Substitutes; D003404:Creatinine