We performed a randomized, double-blinded,
placebo-controlled multicenter trial at five North American LTx
centers. Fifty-nine patients received either TP10 (10 mg/kg, n = 29)
or placebo (P, n = 30) prior to reperfusion of the lung allograft.
This dose achieves > 90% C inhibition for 24 to 48 h; activity
returns to normal by 72 h. Indications for LTx were emphysema
(66%), pulmonary fibrosis (15%), pulmonary hypertension (14%), and
other (5%). Patients with cystic fibrosis were excluded from the
trial. Outcome variables were Pao2/fraction of
inspired oxygen, chest radiograph acute lung injury scores, time
receiving mechanical ventilation, ICU and hospital length of stay
(LOS), survival, and the incidence of acute rejection and infection.