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

• Status: Terminated
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborators: Sanquin; Sanquin Plasma Products BV
• Treatments: Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein; Complement C1s

Criteria

Inclusion Criteria:

• Multi trauma patients

• Femur or pelvic fracture

• Injury Severity Score (ISS) ≥ 18

• Age 18-80 yrs

Exclusion Criteria:

• Congenital C1-inhibitor deficiency

• Use of immune suppressants

• Pregnancy

• Known hypersensitivity for blood products

• Fixation of femur fracture with external fixation or osteosynthesis