THE NECESSITY of submitting data to federal agencies in the process of getting approval for marketing led us to conduct studies in medical student volunteers with several batches of dextran solutions. The size of our study—involving 41 healthy young adults in 59 trials—seems to be sufficiently representative to allow some generalization. The observations made in seven cases point to a type of side effect that might be amenable to premedication with an antihistaminic agent.
Design of Study.
—The quality control of the dextran solutions, as specified in the Defense Medical Purchase Description,1 consisted of the following procedure: (1) measurement of the sublingual temperature; (2) determination of the bleeding time (Ivy method); and (3) thrombocyte count, all being done before intravenous infusion of 500 ml of dextran solution (into an antebrachial vein) over a period of 45 to 60 minutes (approximately 10 ml/min), and again immediately after the infusion, half