FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-024327-24-NL
Enrollment
Unknown
Registered
2011-01-27
Start date
2011-07-12
Completion date
Unknown
Last updated
2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Cetor Product Name: Cetor Product Code: RVG 19303 Pharmaceutical Form: Powder and solvent for solution for injection CAS Number: 0 Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR

Sponsors

University Medical Centre Utrecht
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Attenuation of trauma induced systemic humeral inflammatory response (cytokines) by treatment of these trauma patients with a femur fracture with C1-esterase inhibito (C1-INH). ;Secondary Objective: Effect of C1-INH on clinical outcome (SIRS, ARDS, MODS, mortality, length of hospital stay). ;Primary end point(s): Main study endpoint is the ? interleukine-6 after surgical repair of a femur fracture in trauma patients in the absence of presence of C1-esterase inhibitor.—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026