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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146726
• Other study ID #: Patient Blood Management
• Status: Recruiting
• Start date: February 2, 2022
• Est. completion date: February 2027

Study information

• Verified date: March 2024
• Source: Charite University, Berlin, Germany
• Contact: Claudia Spies, MD, Prof.
• Phone: +49 30 450 55 11 02
• Email: claudia.spies[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2700
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia

Intervention

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.
• 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)

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	?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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Retransfused blood	Retransfused blood from Machine autotransfusion	The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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