NCT01275976

Brief 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

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

January 12, 2011

Last Update Submit

February 3, 2015

Conditions

TraumaInflammationSepsisMultiple Organ Dysfunction Syndrome

Keywords

C1-esterase inhibitorSystemic inflammationSepsisTraumaMultiple Organ Dysfunction SyndromeCytokines

Outcome Measures

Primary Outcomes (1)

  • Delta Interleukine-6

    6 hours after C1-INH administration

Secondary Outcomes (4)

  • Cytokines and other markers of inflammation

    up to 12 days after C1-INH administration

  • Neutrophil redistribution and phenotype

    Up to 12 days after C1-INH administration

  • C1-inhibitor and complement concentration and activity

    Up to 12 days after C1-INH administration

  • Hemodynamic response

    Up to 12 days after C1-INH administration

Study Arms (2)

C1-esterase inhibitor

ACTIVE COMPARATOR

C1-esterase inhibitor, 100 U/kg bodyweight

Drug: C1-esterase inhibitor

Saline 0.9%

PLACEBO COMPARATOR

Saline 0.9%

Other: Saline 0.9%

Interventions

C1-esterase inhibitorDRUG

C1-esterase inhibitor 200 U/kg infusion over 30 minutes, just before the start of the femur or pelvic fixation operation.

Also known as: Cetor® (RVG 19303)
C1-esterase inhibitor
Saline 0.9%OTHER

Infusion, just before the start of the femur or pelvic fixation operation

Saline 0.9%

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Multi trauma patients
  • Femur or pelvic fracture
  • Injury Severity Score (ISS) ≥ 18
  • Age 18-80 yrs

You may not qualify if:

  • Congenital C1-inhibitor deficiency
  • Use of immune suppressants
  • Pregnancy
  • Known hypersensitivity for blood products
  • Fixation of femur fracture with external fixation or osteosynthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Utrecht

Utrecht, 3508 GA, Netherlands

Location

Related Publications (1)

  • Heeres M, Visser T, van Wessem KJ, Koenderman AH, Strengers PF, Koenderman L, Leenen LP. 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. Trials. 2011 Oct 11;12:223. doi: 10.1186/1745-6215-12-223.

    PMID: 21988742DERIVED

MeSH Terms

Conditions

Wounds and InjuriesInflammationSepsisMultiple Organ FailureAngioedemas, Hereditary

Interventions

Complement C1 Inhibitor ProteinSodium Chloride

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeShockAngioedemaVascular DiseasesCardiovascular DiseasesHereditary Complement Deficiency DiseasesPrimary Immunodeficiency DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesImmunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesComplement C1 Inactivator ProteinsSerpinsPeptidesAmino Acids, Peptides, and ProteinsComplement Inactivator ProteinsComplement System ProteinsImmunoproteinsBlood ProteinsProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Luke P Leenen, MD, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
L.P.H. Leenen, MD, PhD, UMC Utrecht.

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 13, 2011

Study Start

April 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

NL(1)