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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01275976
Other study ID # 34932
Secondary ID
Status Terminated
Phase Phase 3
First received January 12, 2011
Last updated February 3, 2015
Start date April 2012
Est. completion date February 2015

Study information

Verified date February 2015
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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


Description:

Systemic inflammation in response to a femur or pelvic fracture and fixation is associated with complications, such as acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS). The injury itself, but also the additional fixation procedure give a release of pro-inflammatory cytokines, in particular interleukin (IL)-6. This results in an aggravation of the initial systemic inflammatory response, and will cause in some patients an increased risk on the development of inflammatory complications, like ARDS and MODS. Which can lead to higher morbidity, mortality and prolonged hospital stay.

Various strategies, such as damage control orthopedics, have been proposed to prevent these complications. Another strategy is to decrease the inflammatory reaction caused by the surgical procedure, and by interventions focused on inhibition of the innate inflammatory response. This will lower the risk of complications.

A promising candidate is the endogenously produced serum protein C1-esterase inhibitor (C1-INH). This protein is an acute phase protein, produced by the liver in response to inflammatory conditions. C1-INH is a major inactivator of the complement system, but important additional anti-inflammatory properties have been demonstrated. A previous study of from our laboratory showed that administration of the drug C1-INH significantly reduced the concentration of circulating pro-inflammatory cytokines such as IL-6, during human experimental endotoxemia. Treatment with C1-INH has been proven to be safe in treatment with humans, even in high dosages and in pregnant patients with C1-INH deficiency.


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
C1-esterase inhibitor
C1-esterase inhibitor 200 U/kg infusion over 30 minutes, just before the start of the femur or pelvic fixation operation.
Other:
Saline 0.9%
Infusion, just before the start of the femur or pelvic fixation operation

Locations

Country Name City State
Netherlands University Medical Centre Utrecht Utrecht

Sponsors (2)

Lead Sponsor Collaborator
UMC Utrecht Sanquin

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Delta Interleukine-6 6 hours after C1-INH administration No
Secondary Cytokines and other markers of inflammation up to 12 days after C1-INH administration No
Secondary Neutrophil redistribution and phenotype Up to 12 days after C1-INH administration No
Secondary C1-inhibitor and complement concentration and activity Up to 12 days after C1-INH administration No
Secondary Hemodynamic response Up to 12 days after C1-INH administration No
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