The effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur fracture - The CAESAR study: study protocol for a randomized controlled trial

Attenuation of the surgery-induced additional systemic inflammatory response by perioperative treatment with C1-esterase inhibitor of trauma patients with a femur fracture.The study is designed as a double-blind randomized placebo-controlled trial. Trauma patients with a femur fracture, Injury Severity Score ≥ 18 and age 18-80 years are included after obtaining informed consent. They are randomized for administration of 200 U/kg C1-esterase inhibitor intravenously or placebo (saline 0.9%) just before the start of the procedure of femoral fixation. The primary endpoint of the study is Δ interleukin-6, measured at t = 0, just before start of the femur fixation surgery and administration of C1-esterase inhibitor, and t = 6, 6 hours after administration of C1-esterase inhibitor and the femur fixation.This study intents to identify C1-esterase inhibitor as a safe and potent anti-inflammatory agent, that is capable of suppressing systemic inflammation in trauma patients. This might facilitate early total care procedures by lowering the risk of inflammation in response to the surgical intervention. This could result in increased functional outcomes and reduced health care related costs.clinicaltrials.gov NCT01275976 (January 12th 2011)Trauma is a major cause of morbidity and mortality in people under the age of 50 years in the western world [1]. Death can occur as a direct result of the trauma induced injury, or as result of a dysfunctional immune response [2]. This excessive immune reaction is caused by the response to tissue injury, such as seen after trauma, surgery or burns. An overwhelming innate immune response is considered to be a major risk factor in the development of post-traumatic organ failure and sepsis. Additional injury, induced by surgical intervention, can increase the overall immune inflammatory reaction [3].The lung is most often the first organ to be affected by an exaggerated systemic immune response, which can result in an acute respiratory distress