drugset / Trial / NCT01275976

Effect of C1-esterase Inhibitor on Systemic Inflammation in Trauma Patients With a Femur or Pelvic Fracture

NCT01275976

Phase 3 Terminated 11 enrolled UMC Utrecht Prothya Biosolutions · collab
RandomizedSingle-groupTriple-blindTreatment

Summary

Trauma and major operation are associated with an excessive inflammation reaction due to tissue injury. This overwhelming immune response is considered to be a major risk factor in the pathogenesis of late inflammatory complications such as acute respiratory distress syndrome (ARDS), multiple organ dysfunction syndrome (MODS) and sepsis. The investigators hypothesize that administration of C1-esterase inhibitor (C1-INH) will attenuate the humane inflammatory response and, thereby, reduce the risk of inflammatory complications due to surgical interventions in trauma patients with a femur or pelvic fracture

Timeline

Start
2012-04
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator CINRYZE Protein / enzyme biologic 200 iu/kg Intravenous