Effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur or pelvic fracture.

Phase 3

Completed

• Conditions: activated immuun system; Systemic inflammation; 10027665; 10002252

• Registration Number: NL-OMON39485
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

Multi trauma patients
Femur fracture and/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
Fixation of the pelvic fracture with external fixation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Delta interleukine-6 after surgical repair of a femur or pelvic fracture in<br /><br>trauma patients in the absence of presence of C1-esterase inhibitor.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Cytokines, cellulair markers, complement<br /><br>- Leukocyt count, CRP, base deficit/excess and lactate<br /><br>- Development of inflammatoiry complications (Acute Respiratory Distress<br /><br>Syndrome, MODS, sepsis, septic shock)<br /><br>- Severity of illness</p><br>