Trial document





This trial has been registered retrospectively.
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  DRKS00015857

Trial Description

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Title

Reduction of the red cell concentrate use by patient blood management. Changing the pretransfusional hemoglobin trigger by education of transfusion triggers and modification of the transfusion ordering form

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

in this observational study we investigated whether the demand for red blood cell concentrates for patients of a teaching hospital could be reduced by two interventions. First education of all physicians about the most recent data on blood values which require transfusion of red blood cells and secondly a change of the ordering form by which physicians order blood from the blood bank.

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Brief Summary in Scientific Language

In this pragmatic, prospective, single centre trial efficacy and safety of implementing a low pretransfusional hemoglobin-trigger for all in-hospital patients is assessed.
At baseline the median pretransfusional hemoglobin value is obtained in surgical and in medical patients. Then a structured education period is performed of physicians of all departments on principles of patient blood management and evidence-based transfusion triggers, followed by measuring the pretransfusion Hb value. then the hospital ordering form is changed, indicating the transfusion threshold triggers and quarterly feedback of the pretransfusional hemoglobin values is given to the departments. Changes in median pretransfusional hemoglobin values will be regularly measured for 2 years and the number of transfused red cell concentrates measured. The safety parameters newly acute coronary syndrome; mortality; in-hospital length of stay are monitored throughout the study period and the required personel ressources measured who are required to establish and needed to maintain the program.

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Organizational Data

  •   DRKS00015857
  •   2018/11/08
  •   2017/07/18
  •   yes
  •   Approved
  •   BB 077/15, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

  •   NIS 406  (Registration Site for non-interventional studies of the Paul-Ehrlich Institut https://www.pei.de/SharedDocs/awb/nis-0401-0500/0406.html?nn=6144494)
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Health Condition or Problem studied

  •   D62 -  Acute posthaemorrhagic anaemia
  •   D63 -  Anaemia in chronic diseases classified elsewhere
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Interventions/Observational Groups

  •   Four study periods were defined (Fig. S1). The first evaluation period (I), July to September 2014, was used as baseline comparator. no education of physicians (historical cohort)
  •   From January to March 2015 physicians of the included departments were trained by one transfusion medicine physician within one hour, department specific courses about department patient-specific pretransfusional hemoglobin triggers according to recent studies and the German national hemotherapy guidelines.16 Additionally basic principles of PBM were discussed. After this training period the second evaluation period (II) followed, from July to September 2015.
  •   As second intervention the in-house transfusion ordering form for blood products was modified showing a colour visualized scale of the Hb-transfusion triggers in relation to risks and benefit and introduced to all wards within one week. Then the third evaluation period (III) was performed, which lasted from January to March 2016. Since the end of active interventions, every three months the transfusion medicine department gives feedback of median pretransfusional Hb-values and the number of red blood cell concentrate transfusions with a pretransfusional Hb-value >10 g/dl by electronic mail to the department heads and the department transfusion officers. These data include the median pretransfusional Hb-values of all departments participating in the study and of the individual department. In addition, a written statement from department transfusion officers is requested for justification of transfusions with pretransfusion Hb-value >10 g/dl. After one year the fourth evaluation period (IV) was performed between January to March 2017 and in June 2018 long term sustainability of the intervention was re-evaluated.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Historical, Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint was the change of median pretransfusional Hb-values between evaluation periods.

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Secondary Outcome

Secondary endpoints were changes in the absolute number of transfused red blood cell concentrates in relation to the number of treated patients, and changes in numbers of red blood cell concentrate-transfusions with a pretransfusional Hb-value of the patient of >10 g/dl.
Safety endpoints were the rate of documented in-hospital acute coronary syndrome, all-cause in-hospital mortality, and the length of in-hospital stay.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/07/01
  •   20000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

All patients of the following departments were enrolled: surgical departments (general, trauma, orthopedics, neurosurgery, urology, gynecology and obstetrics, surgical intensive care) and medical departments (gastroenterology, pulmonology, nephrology, cardiology, hemato-oncology, medical intensive care).

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Exclusion Criteria

red blood cell exchange transfusion; missing Hb value within 24h before transfusion

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Addresses

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    • Universitätsklinikum Greifswald
    • Fleischmannstraße 8
    • 17475  Greifswald
    • Germany
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    • Abteilung TransfusionsmedizinUniversitätsmedizin Greifswald
    • Mr.  Prof Dr  Andreas  Greinacher 
    • Sauerbruchstr
    • 17475  Greifswald
    • Germany
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    • Abteilung TransfusionsmedizinUniversitätsmedizin Greifswald
    • Mr.  Prof Dr  Andreas  Greinacher 
    • Sauerbruchstr
    • 17475  Greifswald
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Greifswald
    • Fleischmannstraße 8
    • 17475  Greifswald
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/07/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.