Trial document




drksid header

  DRKS00017212

Trial Description

start of 1:1-Block title

Title

Danger Response in Polytraumatized Patients

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

A large, multi-center biobank with samples from polytraumatized patients to study the post-traumatic danger and immune response will be established. In traumatized patients immune dysregulations frequently result in infectious complications, sepsis, organ failure, regenerative disturbances and mortality. The aim of the study is to characterize this immunology dysregulation and correlate the same to clinical outcomes. In the present study traumatized patients as well as healthy volunteers will be included. The expected data will provide new optimized therapeutic strategies for traumatized patients. The study is one of the key projects from the German Network "Trauma Research" (Netzwerk Traumaforschung, NTF).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In this large, multi-center biobank samples from polytraumatized patients to study the post-traumatic danger and immune response will be obtained. As controls healthy volunteers will be included.
Based on the data the following questions should be Adresse:
1. How does trauma modulate the production and release of danger molecules, mediators, coagulation factors and other defined biomarker?
2. How does the injury pattern/severity change the post-traumatic (immune) response and regeneration? Specific data on tissue, cellular and molecular base in a time-course are expected.
3. How do organ function parameters as well as immune monitoring predict the clinical outcomes?
We expect following:
1. To characterize the concentration and kinetics of mediators and danger molecules as well as biomarkers after trauma.
2. To determine the correlations and associations between these molecules with the specific injury pattern/severity and clinical outcomes.
3. To provide new knowledge on molecular and cellular mechanisms of the post-traumatic immune response.
4. To generate new pathophysiologically relevant hypothesis in order to provide improvements in the treatment of traumatized patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017212
  •   2019/05/22
  •   [---]*
  •   yes
  •   Approved
  •   94/19, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   V99 -  Unspecified transport accident
  •   S00 -  Superficial injury of head
  •   S06 -  Intracranial injury
  •   S01 -  Open wound of head
  •   S02 -  Fracture of skull and facial bones
  •   S03 -  Dislocation, sprain and strain of joints and ligaments of head
  •   S07 -  Crushing injury of head
  •   S09 -  Other and unspecified injuries of head
  •   R04 -  Haemorrhage from respiratory passages
  •   R02 -  Gangrene, not elsewhere classified
  •   J96 -  Respiratory failure, not elsewhere classified
  •   R09 -  Other symptoms and signs involving the circulatory and respiratory systems
  •   D65 -  Disseminated intravascular coagulation [defibrination syndrome]
  •   I26 -  Pulmonary embolism
  •   S26 -  Injury of heart
  •   I50 -  Heart failure
  •   I60 -  Subarachnoid haemorrhage
  •   I61 -  Intracerebral haemorrhage
  •   R57 -  Shock, not elsewhere classified
  •   I97 -  Postprocedural disorders of circulatory system, not elsewhere classified
  •   A41 -  Other sepsis
  •   J80 -  Adult respiratory distress syndrome
  •   N17 -  Acute renal failure
  •   K72 -  Hepatic failure, not elsewhere classified
  •   S20 -  Superficial injury of thorax
  •   S30 -  Superficial injury of abdomen, lower back and pelvis
  •   S40 -  Superficial injury of shoulder and upper arm
  •   S50 -  Superficial injury of forearm
  •   T20 -  Burn and corrosion of head and neck
  •   T90 -  Sequelae of injuries of head
  •   T91 -  Sequelae of injuries of neck and trunk
  •   T92 -  Sequelae of injuries of upper limb
  •   T93 -  Sequelae of injuries of lower limb
  •   T94 -  Sequelae of injuries involving multiple and unspecified body regions
  •   T95 -  Sequelae of burns, corrosions and frostbite
  •   T98 -  Sequelae of other and unspecified effects of external causes
  •   T68 -  Hypothermia
  •   T79 -  Certain early complications of trauma, not elsewhere classified
  •   T80 -  Complications following infusion, transfusion and therapeutic injection
  •   T88 -  Other complications of surgical and medical care, not elsewhere classified
  •   T81 -  Complications of procedures, not elsewhere classified
  •   T82 -  Complications of cardiac and vascular prosthetic devices, implants and grafts
  •   T83 -  Complications of genitourinary prosthetic devices, implants and grafts
  •   T84 -  Complications of internal orthopaedic prosthetic devices, implants and grafts
  •   T85 -  Complications of other internal prosthetic devices, implants and grafts
  •   T89 -  [---]*
  •   S23 -  Dislocation, sprain and strain of joints and ligaments of thorax
  •   S24 -  Injury of nerves and spinal cord at thorax level
  •   S25 -  Injury of blood vessels of thorax
  •   S26 -  Injury of heart
  •   S27 -  Injury of other and unspecified intrathoracic organs
  •   S28 -  Crushing injury of thorax and traumatic amputation of part of thorax
  •   S29 -  Other and unspecified injuries of thorax
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Group 1: Healthy volunteers

    In both groups blood sampling will be performed. There are no planned special other interventions.
    Group 1 is the reference group, and blood will be taken only once.

    The following research questions should be answered:

    1. How does trauma modulate the release of danger molecules, mediators, coagulation factors and other defined biomarkers?
    2. How does the injury pattern change the post traumatic response and regeneration on organ, cellular and molecular basis during the time course?
    3. What predictive power regarding the clinical outcomes do the analyzed factors have?
  •   Group 2: polytraumatized patients

    Group 2 included severely injured trauma patients and blood will be taken at the following time points:
    1, 8, 24, 48 h and 5, 10 days after trauma.

    The following research questions should be answered:

    1. How does trauma modulate the release of danger molecules, mediators, coagulation factors and other defined biomarkers?
    2. How does the injury pattern change the post traumatic response and regeneration on organ, cellular and molecular basis during the time course?
    3. What predictive power regarding the clinical outcomes do the analyzed factors have?
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- cytokie-/chemokine profiles
- coagulation factors 
- complement factors 
- cell damage and function marker
- DAMPs and PAMPs
- cell s
- organ functions
- diagnoses 
- duration of the stay at the intensive care unit and hospital
- organ failure, mortality

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- mediators 
- stem cells  
- cell marker 
- protein/gene expressions
- differential blood analysis 
- infections
- SIRS
- sepsis
- shock
- organ dysfunctions
- injury
- regenerative disturbances
- complications 
- mortality 
- transfusion
- perioperative complications

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/06/01
  •   6000
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- (Poly)trauma with an ISS ≥ 16
- preclinical time < 120 min
- regular termination of the "shock room" phase
- informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- patients younger then 18
- death within 24 hours post trauma
- ISS < 16
- kardiopulmonal reanimation
- gravidity
- patients who underwent immunosuppressive or chemotherapy within the last three months
- Immune suppressive therapy
- HIV, hepatitis A, B, C, HCV, CMV
- kidney dialysis

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Unfall-, Hand- und WiederherstellungschirurgieUniversitätsklinikum Frankfurt der Goethe Universität
    • 60590  Frankfurt
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Unfall-, Hand- und WiederherstellungschirurgieKlinik der Goethe-Universität
    • Ms.  Prof. Dr. phil. nat.  Borna  Relja 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Unfall-, Hand- undWiederherstellungschirurgieKlinik der Goethe-Universität
    • Ms.  Dr.  Marlene  Bellen 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Gesellschaft für Unfallchirurgie e.V. (DGU)
    • 10623  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Klinik für Unfall-, Hand- und WiederherstellungschirurgieKlinik der Goethe-Universität Frankfurt
    • Theodor-Stern-Kai 7
    • D-60590 
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.