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Completed

NCT Number: NCT00710411

Inflammatory Response After Muscle and Skeleton Trauma

The purpose of this study is to determine the inflammatory response after multiple trauma in humans.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic of Anesthesiology and Clinic of Traumatology, Hand-, Plastic-, and Reconstructive Surgery

Ulm, 89070, Germany

About this study

Polytraumatized patients are via a systemic inflammatory response syndrome at high risk for an uneventful outcome in the posttraumatic phase. One of the main functions of the inflammatory response is the recognition and elimination of damaged tissues and microorganisms. In polytraumatized patients, a huge amount of damaged cells occurs which has to be eliminated by programmed cell death (apoptosis)without damaging surrounding tissues. It remains unclear whether, when and how an interplay of complement system, NF-kB, danger and pattern recognition receptors, apoptosis, mesenchymal stem cells and their regulation may be beneficial and harmful. Differing activation of the complement system, pro-inflammatory biomarkers and predisposing polymorphisms of response and receptor genes are expected to lead to varying outcome. Therefore, this prospective observational study will enroll n=60 polytraumatized patients with an ISS>18 to monitor longitudinally their inflammatory response after trauma and to find out whether there is a discriminating pattern of the cross talk between complement system, biomarkers and apoptosis in patients with beneficial or harmful outcome.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • multiple trauma injury, injury severity score (ISS) > 18 with
  • isolated fractures of the extremities
  • fractures of the extremities combined with blunt/penetrating visceral trauma
  • fractures of the extremities combined with blunt/penetrating thoracic trauma
  • isolated head injury with morphological changes in CCT
  • combination of points 1 - 4

Exclusion criteria

  • life expectancy < 24 hours
  • participation in other trials
  • ISS < 18
  • cardiopulmonary reanimation on the accident scene or dying immediately after hospital admission
  • age < 18 years
  • known or suspected pregnancy
  • patients with ray-treatment or chemotherapy within the last three months

Treatment and study plan

Primary outcomes

  1. Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes

    Time frame: 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma

Secondary outcomes

  1. inflammatory biomarkers, cell surface markers, apoptosis, functional polymorphisms, mesenchymal stem cells, severity of injury (ISS), infections, SIRS, sepsis, shock, organ dysfunctions, severity of disease, ICU length of stay, wound healing, mortality

    Time frame: 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma for biochemical and immunological parameters; ISS on admission; scores on a daily basis; ICU and hospital death on discharge

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

Inflammatory Response in Polytraumatized Patients

Acronym: IRAMST

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jul 4, 2008
Registry last updated
Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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