PLASMA-EXCHANGE MORBIDITY IN GUILLAIN-BARRE-SYNDROME - RESULTS FROM THE FRENCH PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, MULTICENTER STUDY

Objectives: To describe all adverse events occurring during plasma exc hange sessions in adult patients with the Guillain-Barre syndrome. To analyze these events with regard to the technical modalities and biolo gical changes induced by sessions, and to try to identify a population at high risk for adverse events. Design: Double-blind, randomized, pr ospective, multicenter trial. Setting. A total of 28 French and Swiss intensive care units. Patients: The study is based on 220 patients all ocated either to plasma exchange (n = 109) or not (n = 111). This stud y focused on 105 patients who received at least one plasma exchange, w ith replacement fluid secondly allocated by randomization to albumin, or fresh frozen plasma. A total of 105 patients underwent 390 plasma e xchanges. Fifty-five patients received albumin (208 sessions) as repla cement fluid, and 50 patients received fresh frozen plasma (182 sessio ns). Interventions: Prospective monitoring of patients for each sessio n including technical modalities, adverse effects, and biological para meters. Measurements and Main Results. A total of 253 adverse incident s were recorded. At least one adverse incident occurred in 39% of plas ma exchange sessions among 80 (76%) patients. In 15 patients, plasma e xchange treatment had to be discontinued because of severe intolerance (six patients, including three patients with severe bradycardias), in tercurrent complications, mainly infections (four patients), and techn ical difficulties. One patient with pneumococcal septicemia and pneumo nia died during the second plasma exchange session. Fresh frozen plasm a was associated with more adverse incidents than albumin (135 vs. 118 , p = .008). The occurrence of adverse events was also related to the preplasma exchange hemoglobin level assessed before the session (p =.0 4). Otherwise, the frequency of adverse effects did not depend on tech nical modalities (type of equipment, anticoagulation). Age, sex, previ ous history, neurologic severity, and the need for mechanical ventilat ion, as assessed on inclusion in the study, did not modify the risk of adverse effects. Finally, occurrence of bradycardia did not rely on i nitial neurologic severity. Conclusions: These results confirm that fr esh frozen plasma should be abandoned as replacement fluid in plasma e xchanges of Guillain-Barre syndrome patients. They also underline the need for close monitoring of patients during sessions and, especially, the respect of treatment contraindications. Some adverse incidents co uld be attributed to the underlying disease rather than to the plasma exchange session.