Anemia, Surgery, Transfusion-dependent Anemia
Conditions
Brief summary
In this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)) or restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). Primary efficacy endpoint: is a composite of death from any cause and anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic stroke, acute kidney injury stage III, acute mesenteric ischaemia, acute peripheral vascular ischaemia) within 90 days after surgery.
Interventions
DRUGred blood cell transfusion trigger
patients receive a RBC unit with different target ranges for the post-transfusion Hb levels
Sponsors
Johann Wolfgang Goethe University Hospital
Wuerzburg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 70 years of age scheduled for intermediate- or high-risk non-cardiac surgery will be registered * Registered patients will be randomised only if they indeed develop severe anaemia (if Hb level falls ≤ 9 g/dl) during surgery (=day 0) or day 1, 2, or 3 after surgery
Exclusion criteria
* preoperative Hb level ≤ 9 g/dl * chronic kidney disease requiring dialysis * suspected lack of compliance with follow-up procedures * participation in other interventional trials * expected death within 3 months * inability to provide informed consent with absence of a legally authorised representative/ legal guardian * temporary inability to provide informed consent * previous participation in our trial * patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses) * preoperative autologous blood donation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of a composite outcome | 90 days | Composite of death and anaemia-associated events I. All-cause mortality defined as death from any cause. II. Acute myocardial infarction confirmed by a cardiologist III. Acute ischaemic stroke confirmed by a neurologist IV. Acute kidney injury (stage III) defined according to the Kidney Disease Improving Global Outcomes criteria: Increase of plasma creatinine level ≥ 3 times within a time window of 7 days or initiation of renal replacement therapy. V. Acute mesenteric ischaemia defined as ischaemia confirmed by intervention (abdominal surgery or mesenteric angiography). VI. Acute peripheral vascular ischaemia defined as a new non-thrombotic compromised circulation in a limb confirmed by angiography and/or leading to surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients receiving red blood cell transfusion | hospital discharge (an anticipated average of 10 days) | — |
| Number of red blood cell units transfused | hospital discharge (an anticipated average of 10 days) | — |
| Total length of stay in the intensive care unit | hospital discharge (an anticipated average of 10 days) | — |
| Total length of stay in hospital | hospital discharge (an anticipated average of 10 days) | — |
| Number of participants with acute kidney injury stage I-II | hospital discharge (an anticipated average of 10 days) | The occurrence of acute kidney injury (stage I or II) defined according to the Kidney Disease Improving Global Outcomes criteria (stage I: increase of plasma creatinine level ≥ 1.5-1.9 times baseline or ≥ 0.3mg/dl within 48 hours; stage II: increase of plasma creatinine level ≥ 2-2.9 times baseline within a time window of 7 days) during the initial hospital stay |
| Time to infection | 90 days | Time to (first) infection (infection requiring therapeutic intravenous antibiotic treatment (pneumonia, wound infection, sepsis, central line associated blood stream infection)) during the initial hospital stay or leading to hospital re-admission |
| Time to re-hospitalisation | 90 days | Time to (first) re-hospitalisation |
| functional status (Barthel index) | 90 days | Functional status (assessed by Barthel Index) |
| Health-related quality of life | 90 days | Health-related quality of life (assessed by EuroQoL EQ-5D and 12-item World Health Organisation Disability Assessment Schedule WHODAS 2.043) by telephone questionnaire) |
| Occurrence of any individual component of the composite | 1 year | composite components (all-cause mortality, acute myocardial infarction, acute stroke, acute kidney injury stage III, acute mesenteric ischaemia, and/or acute peripheral vascular ischaemia) |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORPatrick Meybohm, MD
Wuerzburg University Hospital
Outcome results
None listed