Trial document




drksid header

  DRKS00016579

Trial Description

start of 1:1-Block title

Title

Anaemia prevalence in surgical patients in Germany in the period 2007 - 2017 – a multicentre, retrospective study

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

https://www.patientbloodmanagement.de/en/pandora/

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

Brief Summary in Lay Language

Worldwide, approximately 30% of the total population suffer from anaemia. Those affected suffer from fatigue, paleness and limited performance, since the oxygen supply of vital organs is limited. Blood loss during surgery may aggravate anaemia and increase the risk of serious organ damage. Due to this, foreign blood transfusions are more commonly performed in anaemic patients. Nonetheless, preoperative anaemia with additional blood transfusion is associated with an increased mortality in the surgical context. Furthermore, preoperative anaemia carries a higher risk of postoperative complications and longer hospital stays.

In a global comparison, Germany is the "leader" in the use of foreign blood transfusions. The reasons for this are still unclear, but could be due to an increased prevalence of anaemia in surgical patients.

This study will cover the multi-annual course of anaemia incidence in different hospitals in Germany. In doing so, both the incidence of preoperative anaemia and hospital-acquired anaemia will be assessed taking various parameters into account.

We will investigate whether anaemia management programs could help diagnose and treat anaemia early, reduce unnecessary blood loss, and promote rational use of third-party blood products.

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

Brief Summary in Scientific Language

The aim of this study is the multicentre assessment of the prevalence of preoperative anaemia within the past 15 years at various German hospitals. We suspect that the prevalence of preoperative anaemia has remained stable for 15 years, or even increased. Furthermore, it is assumed that the prevalence of preoperative anaemia differs significantly between the surgical disciplines and that in the future more discipline-specific anaemia management programs should be initiated.
In the second part of the study, the prevalence of hospital-acquired anaemia will be determined taking into account the patient's age, surgical discipline, type of surgical intervention, hospital stay and time within the last 15 years.
The primary endpoint is the prevalence of preoperative anaemia (considering patient age, surgical discipline, OPS intervention, length of hospital stay, and time within the last 10 years).
Secondary outcomes are prevalence of hospital-acquired anaemia (considering patient age, surgical discipline, OPS intervention, length of hospital stay, and time within the last 10 years), rate of deceased patients, length of hospital stay, and frequency of RBC transfusion.
Hospitals throughout Germany are contacted and motivated to participate in the study. Interested hospitals then apply for a second ethics committee vote. Approximately 10 representative hospitals will analyse routine data of all surgical patients of March (01.03.-15.03.) in 2007, 2012 and 2017. The 2007-2017 period was selected as the RBC transfusion rate in Germany has risen rapidly in this period, but the rate of preoperative anaemia is unclear. Based on the assumption of approximately 1,000-2,000 surgical patients per month per center, there are approximately 4,000-8,000 patients per center and a total of n = 40,000-80,000 patients. Patients who undergo multiple surgeries in the selected month only enter the analysis once.
After exporting the appropriate data on age, Hb value, type of surgical intervention (OPS Code), length of hospital stay, hospital mortality rate, and RBC transfusion (yes / no) data from local hospital information systems, participating hospitals provide us with this data in an anonymised form. Subsequently, the anonymous data is evaluated and the aim is to publish the results of the study in international medical journals and in lay press.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00016579
  •   2019/01/29
  •   [---]*
  •   yes
  •   Approved
  •   517/17, 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

  •   D64.9 -  Anaemia, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The aim of this study is the multicentre assessment of the prevalence of preoperative anaemia within the past 10 years at various German hospitals. We suspect that the prevalence of preoperative anaemia has been stable for 10 years or may even have increased. Furthermore, we assume that the prevalence of preoperative anaemia differs significantly between the surgical disciplines and that in the future more discipline-specific anaemia management programs should be initiated.
    In the second part of the study, the prevalence of hospital-acquired anaemia will be determined taking into account the patient's age, discipline, surgical intervention, hospital stay and time within the last 10 years.
  •   No preoperative anaemia
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Prevention
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Preoperative prevalence of anaemia (taking into account the age of the patient, surgical discipline, OPS intervention, hospital stay and time within the last 15 years)

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

Secondary Outcome

- Prevalence of hospital-acquired anaemia (taking into account the age of the patient, surgical discipline, OPS intervention, length of hospital stay and time within the last 15 years)
- Rate of deaths during hospital stay
- length hospital stay
- frequency of red cell concentrate transfusion

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

Countries of Recruitment

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

Locations of Recruitment

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

Recruitment

  •   Planned
  •   2019/02/01
  •   10000
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

All patients (regardless of age) undergoing surgery (OPS Code 5-01 to 5-92) in the months of March (01.03. - 15.03.) in 2007, 2012, and 2017.

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

Exclusion Criteria

None

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Anästhesiologie, Intensivmedizin und SchmerztherapieUniversitätsklinikum Frankfurt
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • 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
    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
    • Mr.  Prof  Patrick  Meybohm 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • 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 Anästhesiologie, Intensivmedizin und SchmerztherapieUniversitätsklinik Frankfurt
    • Mr.  Prof  Patrick  Meybohm 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • 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
    • Klinik für Anästhesiologie, Intensivmedizin und SchmerztherapieUniversitätsklinik Frankfurt
    • Mr.  Prof  Patrick  Meybohm 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
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.