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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia
• Intervention / Treatment: Other: BARMER anemia treatment; Other: NON-BARMER anemia treatment

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.

• Study Type: Observational
• Enrollment (Estimated): 2700

Contacts and Locations

• Study Contact: Name: Claudia Spies, MD, Prof.; Phone Number: +49 30 450 55 11 02; Email: claudia.spies@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin
    • Sub-Investigator: Lutz Kaufner, MD
    • Sub-Investigator: Franziska Büttner, MD
    • Contact: Claudia Spies, MD, Prof.; Phone Number: +49 30 450 55 10 01; Email: claudia.spies@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients with preoperative anemia and an electivesurgical intervention with a probability of transfusion > 10%

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective BARMER insured patients; Group I: BARMER insured patients with preoperative anemia and an elective (N5) surgical intervention with a probability of transfusion > 10%. Central measures in this group are the IV contract for the creation of an organizational and financing structure for the guideline-compliant detection, diagnosis and treatment of preoperative anemia and the evaluation of the machine autotransfusion as part of the preoperative premedication visit in anesthesiology (implementation is the responsibility of the patient blood management (PBM) service).	Other: BARMER anemia treatment; 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.
Retrospective patients insured with another statutory health insurer than BARMER; Group II: Patients not insured with BARMER and with preoperative anemia and an elective (N5) surgical intervention with a probability of transfusion > 10% and receive early anemia detection.	Other: NON-BARMER anemia treatment; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients	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.	The participants are followed up until the end of hospital stay, an expected average of 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients	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.	The participants are followed up until the end of hospital stay, an expected average of 7 days
Number of machine autotransfusion respectively autologous transfusion	Number of patients which received machine autotransfusion	The participants are followed up until the end of hospital stay, an expected average of 7 days
Rate of transfused patients	Number of patients which received transfusions	The participants are followed up until the end of hospital stay, an expected average of 7 days
∆Hb before therapy of anemia and before surgical intervention	Difference between Hemoglobin before therapy of anemia and Hemoglobin before surgical intervention.	The participants are followed up until the end of hospital stay, an expected average of 7 days
Number of allogeneic transfusions	Number of red cell concentrates per patient	The participants are followed up until the end of hospital stay, an expected average of 7 days
Treatment period	Treatment period between begin of anemia therapy and surgical intervention	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 ∆Hemoglobin	Treatment dose of anemia therapeutics in relation to the difference between Hemoglobin before begin of anemia therapy and the Hemoglobin before surgical intervention	The participants are followed up until the end of hospital stay, an expected average of 7 days
Side effects 1	Side effects of anemia therapeutics	The participants are followed up until the end of hospital stay, an expected average of 7 days
Side effects 1	Type of side effects of anemia therapeutics	The participants are followed up until the end of hospital stay, an expected average of 7 days
Differences of secondary outcome measures	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).	The participants are followed up until the end of hospital stay, an expected average of 7 days
Anemia course	Change of Hemoglobin during hospital stay until hospital discharge	The participants are followed up until the end of hospital stay, an expected average of 7 days
Length of hospital stay	Length of stay at the hospital	The participants are followed up until the end of hospital stay, an expected average of 7 days
Length of intensive care unit stay	Length of stay at the intensive care unit	The participants are followed up until the end of hospital stay, an expected average of 3 days
Rate and type of postoperative complications	Rate and type of Organ complications which are documented in the hospital records.	The participants are followed up until the end of hospital stay, an expected average of 7 days
Side effects 2	Type of side effects of machine autotransfusion	The participants are followed up until the end of hospital stay, an expected average of 7 days
Rate of side effects	Rate of side effects of machine autotransfusion	The participants are followed up until the end of hospital stay, an expected average of 7 days
Volumes of collected blood	Volumes of collected blood from Machine autotransfusion	The participants are followed up until the end of hospital stay, an expected average of 7 days
Retransfused blood	Retransfused blood from Machine autotransfusion	The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 1	Quality indicators for machine autotransfusion as process time	The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 2	Quality indicators for machine autotransfusion as operating time	The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 3	Quality indicators for machine autotransfusion as number of washing processes	The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 4	Quality indicators for machine autotransfusion as surgery department	The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 5	Quality indicators for machine autotransfusion as patient population	The participants are followed up until the end of hospital stay, an expected average of 7 days
Rate of In-hospital mortality	Mortality is measured during hospital stay	The participants are followed up until the end of hospital stay, an expected average of 7 days

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Transfusion; Machine autotransfusion
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: Patient Blood Management

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No