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

Active, not recruiting

• Conditions: systemic inflammation, inflammatory complication (SIRS, sepsis, ARDS, MODS); MedDRA version: 12.1Level: LLTClassification code 10061218Term: Inflammation; MedDRA version: 12.1Level: LLTClassification code 10062357Term: SIRS; MedDRA version: 12.1Level: LLTClassification code 10051553Term: Complement factor C1; MedDRA version: 12.1Level: LLTClassification code 10016454Term: Femur fracture

• Registration Number: EUCTR2010-024327-24-NL
• Lead Sponsor: niversity Medical Centre Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-27
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Multi-trauma patients
- Femur fracture
- ISS =18
- Age 18-80 year
- Informed consent (when proxy consent is obtained and the patient leaves the ICU in good mental health, personal informed consent is additionally necessary).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Fixation of the femoral fracture with external fixation or osteosynthesis.
- Congenital C1-inhibitor deficiency
- Use of immune suppressants
- Pregnancy
- Known hypersensitivity for blood products
- Participation in another study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified