Trial document




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  DRKS00015072

Trial Description

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Title

Prevalenz of Factor XIII deficiency in burn injuries

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In industrialized countries the incidence of burn injuries is 5 - 10%. In Germany nearly 20,000 children and adults suffer a burn injury of varying severity each year. In >70% burn injuries are due to scalding (AWMF guideline). Impared wound healing can cause lifelong stigmatization of affected patients and results in a lot of necessary aesthetic surgery. Optimal wound care should prevent this. However, wound healing requires fibroblast growth based on a stabilized fibrin thrombus an the transglutaminase factor XIII playes a crucial role. In addition to procoagulant effects with cross-linking of fibrin threads and integration of α2-antiplasmin, also inflammatory and pro-angiogenic effects are known(Weber et al). Some studies have shown that especially patients with burn injuries may have acquired factor XIII deficiency (Burckhardt et al.). The prevalence in children and the effects on wound healing processes are completely unclear.
The aim of the study is to determine the prevalence of factor XIII deficiency in patients ≤ 18 years with moderate and severe burn injuries (≥ 10% VKOF - burned body surface area) and to determine the prevalence of bleeding complications, thrombotic complications and impared wound healing

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Brief Summary in Scientific Language

In industrialized countries the incidence of burn injuries is 5 - 10%. In Germany nearly 20,000 children and adults suffer a burn injury of varying severity each year. In >70% burn injuries are due to scalding (AWMF guideline). Impared wound healing can cause lifelong stigmatization of affected patients and results in a lot of necessary aesthetic surgery. Optimal wound care should prevent this. However, wound healing requires fibroblast growth based on a stabilized fibrin thrombus an the transglutaminase factor XIII playes a crucial role. In addition to procoagulant effects with cross-linking of fibrin threads and integration of α2-antiplasmin, also inflammatory and pro-angiogenic effects are known(Weber et al). Some studies have shown that especially patients with burn injuries may have acquired factor XIII deficiency (Burckhardt et al.). The prevalence in children and the effects on wound healing processes are completely unclear.
The aim of the study is to determine the prevalence of factor XIII deficiency in patients ≤ 18 years with moderate and severe burn injuries (≥ 10% VKOF - burned body surface area) and to determine the prevalence of bleeding complications, thrombotic complications and impared wound healing

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Organizational Data

  •   DRKS00015072
  •   2018/07/19
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  •   yes
  •   Approved
  •   17-498, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   T30.0 -  Burn of unspecified body region, unspecified degree
  •   D68.9 -  Coagulation defect, unspecified
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Interventions/Observational Groups

  •   non interventional, observational Trial
    single arm, no comparison

    detection of prevalence of factor XIII deficiency in burn injury
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Prevalenz of factor XIII deficiency in burn injury

Study Centre: Dr. von Hauner Children´s Hospital. Germany

FaStart: 7/2018

Factor XIII Measurement on days 0, 1, 5, 10, 20

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Secondary Outcome

rate of bleeding and impared wound healing

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/07/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   18   Years
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Additional Inclusion Criteria

children ≤ 18 years, with moderate and severe burn injuries (≥ 10%) treated on PICU in the Dr. von Hauner Childen´s Hospital

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Exclusion Criteria

None

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Addresses

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    • Kinderintensivstation, Abt. Päd. HämostaseologieKinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital
    • Mr.  Dr.  Martin  Olivieri 
    • Lindwurmstr. 4
    • 80337  München
    • Germany
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    • Kinderintensivstation, Abt. Päd. HämostaseologieKinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital
    • Mr.  Dr.  Martin  Olivieri 
    • Lindwurmstr. 4
    • 80337  München
    • Germany
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    • Kinderintensivstation, Abt. Päd. HämostaseologieKinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital
    • Mr.  Dr.  Martin  Olivieri 
    • Lindwurmstr. 4
    • 80337  München
    • Germany
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Sources of Monetary or Material Support

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    • CSL Behring
    • Philipp-Reis-Str. 2
    • 65795  Hattersheim
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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