Outcomes of Patient Blood Management in Severely Anemic Patients

Severe Anemia Clinical Trial

Official title:

Impact of Transfusions and Patient Blood Management on Morbidity and Mortality in Severe Anemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06345417
• Other study ID #: O-PBM1
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: Helios Klinik Gotha/Ohrdruf
• Contact: Petra Seeber
• Phone: +49-3621-2200
• Email: petra.seeber[@]helios-gesundheit.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational cohort study is to compare patients with very low red blood counts who receive different therapy. Its main question[s] it aims to answer are:

• Which group of patients dies more frequent: Patients who receive patient blood management only, patients who receive patient blood management and transfusions or patients who receive only transfusions?

• Among these groups: which group of patients has more complications during hospital stay? Patients will either receive patient blood management, which is the management of anemia, bleeding and coagulation problems, will receive transfusions, that is, blood from other people, or a mix of both.

Description:

Background:

There seems to be a clear relationship between hemoglobin level and inhospital morbidity and mortality. To mitigate negative effects of lower hemoglobin levels, that is, anemia, transfusions are given when the hemoglobin level of the patient reaches a point deemed detrimental by the treating health care personnel. Patient Blood Management (PBM) adds to the armamentarium of anemia therapy, starting typically well before transfusions are given, and sometimes beyond this point. PBM utilizes medical strategies to enhance the patients own red cell mass and to alleviate the ill effects of disease and bleeding on hematopoesis and homeostasis.

Objective:

The objectives of the present study is to investigate the effects of 2 different management strategies of severe anemia, namely PBM exclusively or PBM with transfusion therapy, and compare them to standard transfusion therapy as regards inhospital mortality and morbidity.

Hypothesis: It is hypothesized that severely anemic participants who received a combination of PBM and restrictive transfusion regime would have a lower mortality and less complications than participants receiving a liberal transfusion therapy without PBM, while participants not being transfused at all will have increased mortality and morbidity.

Setting: The study will be performed at HELIOS Klinikum Gotha (HKG) and Helios Klinikum Erfurt (HKE) which are two neighboring hospitals with overlapping personnel, purchasing, IT departments and standard operating procedures. Both hospitals offer basic, advanced and specialist care to their communities. HKG offers PBM to their patients, while HKE does not.

Data sources: Data will be sourced from the hospital information systems of HKG and HKE.

Diseases are coded with the ICD-10-GM (International Code of Diseases, Version 10, Germany) and procedures using the OPS code (Procedure Key, analogous to the International Code of Procedures).

Participants: All adult patients treated between 1.6.2008 and 31.12.2020 in HKG and HKE will be eligible for enrollment when they were treated by a specialty that both hospitals offer and suffer from severe anemia, defined as a nadir hemoglobin of < 8 g/dL.

Interventions:

Study group 1: Participants in this group received full PBM measures as clinically appropriate, but were not transfused at all.

Study group 2: Participants in this group received convenience measures of PBM and were transfused as deemed necessary in an environment where a restrictive transfusion strategy is encouraged.

Control:

The control group was treated without systematic PBM offered to patients and transfusions were the only standard of care for severely anemic patients.

Outcome:

Primary outcome is inhospital mortality. Secondary outcomes are morbidity measures, such as acute myocardial infarction, blood stream infection, cerebrovascular accident, transfusion complications, readmission rates, etc.

Study design:

This is a dual-center, retrospective observational cohort study. Reporting of results will be performed in line with the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement extension of the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement.

The study will be guided by a study protocol with an attached statistical analysis plan.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: May 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult

• nadir hemoglobin < 8 g/dL

Exclusion Criteria:

• treatment in a non-comparable specialty

• transfer from hospital in the first 6 h after arrival

• requesting PBM / transfusion-free therapy but not offered

Related Conditions & MeSH terms

• Anemia
• Severe Anemia

Intervention

Other:
• Patient Blood Management (PBM)
PBM is a strategy to manage the participant's own blood. Its focus is on anemia, bleeding and coagulation management.

Biological:
• Allogeneic transfusion
Anemia is treated by administering donor red cells, and bleeding or coagulopathy by plasma, platelets or other donor blood products.

Locations

Country	Name	City	State
Germany	Helios Klinikum	Erfurt	Thuringia
Germany	Helios Klinikum	Gotha	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
Helios Klinik Gotha/Ohrdruf	Helios Klinikum Erfurt

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of dead participants at the end of hospitalization (inhospital mortality)	Death at discharge from hospital	From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
Secondary	Number of participants with surgical wound complications	Number of participants with a documented presence of surgical wound complications (according to pre-specified ICD list)	From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
Secondary	Number of participants with a documented acute myocardial infarction	Acute myocardial infarction (as documented by increase in troponin in conjunction with AMI diagnose)	From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
Secondary	Number of participants suffering renal injury	Renal injury (according to RIFLE criteria)	From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
Secondary	Number of days spent in hospital (Length of stay in hospital)	Length of stay in hospital, calculated in days	From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
Secondary	Number of participants readmitted to the studied hospital	Readmission within 30 days	From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
Secondary	Number of participants with a documented transfusion reaction	Transfusion reactions (according to ICD codes T80.3 and T80.4)	From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
Secondary	Number of participants receiving an allogeneic transfusion	Transfusion rates per admission, calculated for red blood cells, platelets, plasma	From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
Secondary	Number of participants treated in an intensive care ward	Indicator whether or not the participant was treated in an intensive care unit	From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
Secondary	Number of participants with documented respiratory complications	Respiratory complications as documented by ventilation support rate (per admission)	From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months