Clinical trial NCT05146726: Patient Blood Management Charité (PBM-Charité): Structured Detection, Differentiated Diagnostics and Therapy of Preoperative Anemia and Use of Machine Autotransfusion in Elective Interventions
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anemia
Keywords: Transfusion
Machine autotransfusion
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with preoperative anemia and an electivesurgical intervention with a probability of transfusion \> 10%

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of patients
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary outcomes:
measure: Number of patients
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Number of machine autotransfusion respectively autologous transfusion
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Rate of transfused patients
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: ∆Hb before therapy of anemia and before surgical intervention
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Number of allogeneic transfusions
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Treatment period
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Treatment dose of anemia therapeutics in relation to ∆Hemoglobin
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Side effects 1
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Side effects 1
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Differences of secondary outcome measures
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Anemia course
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Length of hospital stay
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Length of intensive care unit stay
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 3 days
measure: Rate and type of postoperative complications
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Side effects 2
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Rate of side effects
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Volumes of collected blood
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Retransfused blood
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Quality indicator 1
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Quality indicator 2
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Quality indicator 3
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Quality indicator 4
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Quality indicator 5
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Rate of In-hospital mortality
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: