iberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 2470

Inclusion Criteria

Inclusion Criteria for Registration (Step I)
1. Elderly patients (>= 70 years)
2. Undergoing intermediate- or high-risk non-cardiac surgery (according to the ESC/ESA Guidelines: surgery-related risk of cardiovascular death and myocardial infarction)
a. Intermediate risk (30-day risk 1-5%): e.g., intraperitoneal (splenectomy, hiatal hernia), peripheral arterial angioplasty, endovascular aneurysm repair, head and neck, major neurological/orthopaedic (hip and spine), major urological, major gynaecological, intra-thoracic surgery
b. High-risk (30-day risk > 5%): e.g., aortic and major vascular, open limb revascularisation, (partial) duodeno-pancreatic, (partial) liver resection, oesophagectomy, adrenal or (partial or radical) renal resection, total cystectomy
3. Written informed consent; obtained before surgery from the patients or from their legally authorised representative (authorisation including clinical research/clinical trials) / legal guardian, if the patient is unable to provide informed consent.

Inclusion Criteria for Randomisation (Step II)
Registered patients will be randomised only if and as soon as Hb falls <= 9 g/dl (in spite of possible autologous transfusion) during surgery (=day 0) or day 1, 2, or 3 after surgery. If Hb remains > 9 g/dl (even after a two-stage surgery) patient does not enter the main study but vital status (all-cause mortality) will be determined 90 days after surgery

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2470

Exclusion Criteria

Exclusion Criteria for Registration (Step I)
1. preoperative Hb level <= 9 g/dl
2. chronic kidney disease requiring dialysis
3. suspected lack of compliance with follow-up procedures
4. participation in other interventional trials
5. expected death within 3 months
6. inability to provide informed consent with absence of a legally authorised representative/ legal guardian
7. temporary inability to provide informed consent
8. previous participation in our trial
9. Patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah’s Witnesses)
10. preoperative autologous blood donation

Exclusion Criteria for Randomisation (Step II)
1. Occurrence of any component of composite endpoint after registration:
- Acute myocardial infarction
- Acute ischaemic stroke
- Acute kidney injury (stage III)
- Acute mesenteric ischaemia
- Acute peripheral vascular ischaemia
2. Any allogeneic blood transfusion after registration