Comparative study of the efficacy and safety of intranasal DDAVP administered to normal blood donors

A study of the efficacy and safety of intranasal 1-deamino-8-D-arginine vasopressin (DDAVP; 300 micrograms) in normal blood donors was carried out in a double-blind, controlled, comparative study. In addition, the effect of heparin or citrate anticoagulation of blood on the recovery of factor VIII (FVIII) in plasma, cryoprecipitate, and a FVIII concentrate was assessed. Citrated plasma from placebo (CP) or DDAVP-treated donors (CD) contained 1103 +/- 73 and 1470 +/- 141 units per liter of FVIII, respectively (p less than 0.01), whereas the heparinized plasma from placebo (HP) or DDAVP-treated donors (HD) contained 1328 +/- 130 (p less than 0.01) and 2023 +/- 358 units per liter (p less than 0.01), respectively. The FVIII could be recovered in both cryoprecipitate and cold-reprecipitated cryoprecipitate (CRC) fractions. DDAVP treatment improved FVIII recovery by 41 percent in the concentrate from citrated plasma (p less than 0.01) and by 127 percent in that from heparinized plasma (p less than 0.01). The specific activity of concentrates from the CP, CD, HP, and HD groups was 0.95 +/- 0.1, 1.4 +/- 0.1 (p less than 0.01), 0.9 +/- 0.1, and 1.47 +/- 0.2 U per mg of protein (p less than 0.01), respectively. The stability of the final product was the same, regardless of the method of treatment or collection. The side effects of intranasal treatment were mild and transient and occurred with similar frequency in both placebo and DDAVP treatment groups.(ABSTRACT TRUNCATED AT 250 WORDS)