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NCT Number: NCT05146726

Patient Blood Management Charité (PBM-Charité): Structured Detection, Differentiated Diagnostics and Therapy of Preoperative Anemia and Use of Machine Autotransfusion in Elective Interventions

The aim of patient blood management is to reduce the risks of perioperative anemia- and transfusion-associated complications by limiting the use and the need for allogeneic blood transfusion.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin

Berlin, 13353, Germany

Location status: Recruiting

About this study

Background of this multimodal, multidisciplinary concept are numerous studies that have shown an association between preoperative anemia and/or a perioperative transfusion and a worse treatment outcome concerning morbidity and mortality. Diagnosis and therapy of preoperative anemia and the use of machine autotransfusion are central components of this integrated supply concept based on the S3 guideline "Präoperative Anämie", which need to be incorporated into the clinical processes.

Therefore, all patients undergoing elective surgery with a probability of transfusion > 10% receive an anemia detection during their premedication visit. Patients who are insured with BARMER also get anemia diagnostic and therapy. Patients of other health insurances receive a recommendation to anemia diagnostics and therapy sent to surgical department. Based on an analysis of the primary and secondary endpoints of this prospective cohort study, the implementation of the mentioned guideline-compliant measures in everyday clinical practice and the effectiveness of an IV-PBM (Patient blood management) are to be examined. Thus, if necessary, other health insurances could join the patient blood management (PBM) IV concept. The aim is to provide evidence of an improved quality of treatment and the generalized application of PBM measures within the scope of the innovative PBM care form described.

Who can participate

Healthy volunteers accepted: No

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

Prospective:

Inclusion criteria

  • age ≥ 18 years
  • male and female patients
  • patients eligible for inclusion: by the patient, preoperatively
  • patients who are insured with BARMER
  • patients with preoperative anemia and an elective (N5) surgical intervention with a probability of transfusion > 10%

additionally for the use of MAT:

  • indication of machine autotransfusion
  • high blood loss (> 500ml / 10-20 % of estimated blood volume) beside of indication interventions (surgery under dual platelet inhibition, high individual bleeding risk, special antibodies / rare blood group, rejection of allogeneic blood)

Exclusion criteria

  • patients with emergency interventions
  • rejection of study participation
  • pregnancy, elective caesarean section or breastfeeding
  • not enough German language skills
  • accommodation in an institution because of judicial or administrative order
  • employee of Charité
  • missing of declaration of consent

Retrospective:

Inclusion criteria

-Data since September 2021-February 2024 of patients who are not insured with BARMER with elective (N5) interventions with a transfusion probability > 10% (indication list) with a preoperatively existing anemia

additionally for the use of MAT:

  • indication of machine autotransfusion
  • high blood loss (> 500ml / 10-20 % of estimated blood volume) beside of indication interventions (surgery under dual platelet inhibition, high individual bleeding risk, special antibodies / rare blood group, rejection of allogeneic blood)

Treatment and study plan

BARMER anemia treatment

Other

BARMER insured patients are informed about the machine autotransfusion directly by the patient blood management (PBM) service and its intraoperative use is organized. The aim of these measures is to ensure that the intraoperative transfusion trigger does not fall below the intraoperative transfusion trigger by integrating the PBM into standard care and to avoid a perioperative transfusion. In addition, a postoperative treatment recommendation is made for the cause-related anemia treatment, e.g. in order to reduce the risk of a renewed anemia-related perioperative transfusion risk in the event of a possible follow-up operation or other elective operations.

NON-BARMER anemia treatment

Other

Patients not insured with BARMER also receive early anemia detection, selection according to indication intervention (transfusion probability> 10%) and evaluation for machine autotransfusion through the above-mentioned patient blood management (PBM) restructuring of standard care. In the case of preoperative anemia before an indication intervention and / or an intervention with machine autotransfusion application, the operating clinic will be given a recommendation by the PBM service for the diagnosis and treatment of the preoperative anemia and / or the use of the machine autotransfusion (implementation is the responsibility of the operating clinic)

Primary outcomes

  1. Number of patients

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    The amount of patients with differential diagnostics and causally appropriate therapy of a preoperative anemia of all patients with preoperative anemia before an elective surgical intervention with a probability of transfusion > 10% at study completion date = third year after start date (implementation rate of therapy recommendation). Approximately 9600 patients will be enrolled in the study. The data is evaluated after 3 years.

Secondary outcomes

  1. Number of patients

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    The amount of patients with differential diagnostics and causally appropriate therapy of a preoperative anemia of all patients with preoperative anemia before an elective surgical intervention with a probability of transfusion > 10% after the first and second year after start date (implementation rate of therapy). The data of 2 is evaluated after 1 year and 2 years.

  2. Number of machine autotransfusion respectively autologous transfusion

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Number of patients which received machine autotransfusion

  3. Rate of transfused patients

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Number of patients which received transfusions

  4. ∆Hb before therapy of anemia and before surgical intervention

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Difference between Hemoglobin before therapy of anemia and Hemoglobin before surgical intervention.

  5. Number of allogeneic transfusions

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Number of red cell concentrates per patient

  6. Treatment period

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Treatment period between begin of anemia therapy and surgical intervention

  7. Treatment dose of anemia therapeutics in relation to ∆Hemoglobin

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Treatment dose of anemia therapeutics in relation to the difference between Hemoglobin before begin of anemia therapy and the Hemoglobin before surgical intervention

  8. Side effects 1

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Side effects of anemia therapeutics

  9. Side effects 1

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Type of side effects of anemia therapeutics

  10. Differences of secondary outcome measures

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Differences of secondary outcome measures 2. - 10. mentioned above between long term and short term treatment (anemia therapy, long term treatment >3 weeks preoperative, short term treatment 1 - 3 days preoperative).

  11. Anemia course

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Change of Hemoglobin during hospital stay until hospital discharge

  12. Length of hospital stay

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Length of stay at the hospital

  13. Length of intensive care unit stay

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 3 days

    Length of stay at the intensive care unit

  14. Rate and type of postoperative complications

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Rate and type of Organ complications which are documented in the hospital records.

  15. Side effects 2

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Type of side effects of machine autotransfusion

  16. Rate of side effects

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Rate of side effects of machine autotransfusion

  17. Volumes of collected blood

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Volumes of collected blood from Machine autotransfusion

  18. Retransfused blood

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Retransfused blood from Machine autotransfusion

  19. Quality indicator 1

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Quality indicators for machine autotransfusion as process time

  20. Quality indicator 2

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Quality indicators for machine autotransfusion as operating time

  21. Quality indicator 3

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Quality indicators for machine autotransfusion as number of washing processes

  22. Quality indicator 4

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Quality indicators for machine autotransfusion as surgery department

  23. Quality indicator 5

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Quality indicators for machine autotransfusion as patient population

  24. Rate of In-hospital mortality

    Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days

    Mortality is measured during hospital stay

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Patient Blood Management Charité (PBM-Charité): ): Cohort Study About Structured Detection, Differentiated Diagnostics and Therapy of Preoperative Anemia and Use of Machine Autotransfusion in Elective Interventions

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 7, 2021
Registry last updated
Jul 2, 2025

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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