A prospective trial on the safety of long-term intensive plasmapheresis in donors

There are still concerns about the safety of long-term intensive donor plasmapheresis, because the reasons that donors drop out of plasmapheresis programmes have not been determined in prospective studies.

Seventy-two donors were switched from a moderate plasmapheresis programme to an intensive plasmapheresis programme and observed over a 3-year period. In addition to measuring total serum protein (TSP), albumin, immunoglobulin G (IgG) and haemoglobin (Hb) levels, parameters of iron metabolism and blood coagulation, and biochemical cardiovascular risk markers, were determined at baseline and at every 15th donation. We also collected statements from donors who dropped out of the plasmapheresis programme about their reasons for withdrawal.

Dropouts were predominantly related to socioeconomic (n = 34) or medical reasons not related to plasma donations (n = 8). Three donors had to drop out when their TSP levels fell below threshold for the third time within a 5-week period. At baseline, donors had significantly lower TSP, albumin, IgG, Hb and ferritin levels than gender-matched and age-matched non-donor controls. However, subsequent intensive plasmapheresis over 3 years did not impair the individuals' ability to donate plasma. TSP, IgG, Hb, ferritin, transferrin, cardiovascular risk markers and parameters of blood coagulation did not change significantly during the observation period.

The reasons why donors cease to participate in intensive plasmapheresis programmes are predominantly not directly related to the plasma donation itself.