Managing preoperative anemia and blood transfusion in elective surgeries
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
This study is testing whether better management of anemia before elective surgeries can help patients avoid complications and improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05146726 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patient blood management to reduce complications associated with preoperative anemia and blood transfusions during elective surgeries. It involves structured detection and differentiated diagnostics of anemia, particularly for patients with a high probability of needing transfusions. Patients insured with BARMER will receive specific anemia diagnostics and therapy, while others will be recommended for similar care. The study aims to evaluate the effectiveness of these interventions in improving treatment outcomes based on established clinical guidelines.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with preoperative anemia undergoing elective surgeries and insured with BARMER.
Not a fit: Patients who may not benefit include those undergoing emergency surgeries, those who do not speak sufficient German, or those who are pregnant or breastfeeding.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risks associated with preoperative anemia and transfusions, leading to better surgical outcomes for patients.
How similar studies have performed: Other studies have shown positive outcomes with similar patient blood management approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Berlin
- Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Claudia Spies, MD, Prof.
- Email: claudia.spies@charite.de
- Phone: +49 30 450 55 11 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.