Thrombolysis and Deferoxamine in Middle Cerebral Artery Occlusion
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
Iron overload has been associated with greater brain injury in ischemia/reperfusion
experimental stroke models and ischemic stroke patients, especially in those treated with
thrombolytic treatment. Deferoxamine administration, an iron chelator, offers a
neuroprotective action in ischemia/reperfusion animal models.
Primary objective: To evaluate the security and tolerability of deferoxamine endovenous
treatment in acute ischemic stroke patients treated with iv. tPA.
Secondary objectives: To study pharmacokinetics of deferoxamine given by endovenous bolus (10
mg/Kg) followed by 72-hour continuous intravenous infusion (20, 40 o 60 mg/Kg). To evaluate
the deferoxamine effect in clinical outcome, infarct volume and hemorrhagic transformation
and brain edema development.
Methodology: Double-blind, randomized, placebo controlled, dose-finding phase II clinical
trial. Study stages: 1st: bolus+20 mg/Kg/day vs. Placebo (n=15:5); 2nd: bolus+40 mg/Kg/day
vs. Placebo (n=15:5); 3rd: bolus+60 mg/Kg/day vs placebo (n=15:5). These doses will be
increased according to security results of the previous stage. Patients will be continuously
monitored in stroke units. Laboratory parameters will be measured at baseline, 24h, 72h and
30 days to evaluate adverse events related to the drug. Serum deferoxamine and feroxamine
concentrations will be measured along time after the injection in a subgroup of patients to
the pharmacokinetics study. CT scan will be performed at 24-36h to assess hemorrhagic
transformation and brain edema. The NIH Stroke Scale will be evaluated during
hospitalization, and the Rankin score at discharge and 3 months.
If deferoxamine demonstrate to be secure and well tolerated treatment in acute stroke
patients, it may be a new therapy option to lower the brain injury after ischemia and
reperfusion.