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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04978285




Registration number
NCT04978285
Ethics application status
Date submitted
16/07/2021
Date registered
27/07/2021
Date last updated
13/07/2022

Titles & IDs
Public title
Association of Postoperative Anaemia With Patient-centred Outcomes
Scientific title
Association of Postoperative Anaemia With Patient-centred Outcomes
Secondary ID [1] 0 0
544/12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia After Surgery 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Anemia

Postoperative anemia - All patients enrolled in the RELIEF trial in which a postoperative Day 1-3 hemoglobin concentration was measured. Anaemia will be defined according to the World Health Organisation definition (males Hb <130 g/L, and female Hb <120 g/L).

No postoperative anemia - All patients enrolled in the RELIEF trial in which a postoperative Day 1-3 hemoglobin concentration was measured. No anaemia will be defined according to the World Health Organisation definition (males Hb =130 g/L, and females Hb =120 g/L).


Other interventions: Anemia
Depends on Day 3 Hb result
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Persistent disability or death by 90 days
Timepoint [1] 0 0
90 days after surgery
Secondary outcome [1] 0 0
Death: all-cause mortality at 90 days, then up to 12 months after surgery
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
A composite (pooled) and individual septic complications: sepsis, surgical site infection, anastomotic leak, and pneumonia
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Sepsis: using Centers for Disease Control and Prevention (CDC) with National Healthcare Safety Network (NHSN) criteria
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Surgical site infection
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
Pneumonia
Timepoint [5] 0 0
30 days
Secondary outcome [6] 0 0
Anastomotic leak
Timepoint [6] 0 0
30 days
Secondary outcome [7] 0 0
Acute kidney injury
Timepoint [7] 0 0
30 days
Secondary outcome [8] 0 0
Unplanned admission to ICU within 30 days of surgery
Timepoint [8] 0 0
30 days
Secondary outcome [9] 0 0
ICU stay
Timepoint [9] 0 0
30 days
Secondary outcome [10] 0 0
Hospital stay
Timepoint [10] 0 0
30 days
Secondary outcome [11] 0 0
Quality of recovery
Timepoint [11] 0 0
Postoperative Days 3 and 30
Secondary outcome [12] 0 0
Hospital re-admission
Timepoint [12] 0 0
At 3, 6 and 12 months.

Eligibility
Key inclusion criteria
1. Adults (=18 years) undergoing elective major surgery and providing informed consent

2. All types of open or lap-assisted abdominal or pelvic surgery with an expected
duration of at least 2 hours, and an expected hospital stay of at least 3 days

3. At increased risk of postoperative complications, as defined by any of the following
criteria:

1. age =70 years

2. known or documented history of coronary artery disease

3. known or documented history of heart failure

4. diabetes currently treated with an oral hypoglycemic agent and/or insulin

5. preoperative serum creatinine >200 micromol/L (>2.8 mg/dl)

6. morbid obesity (BMI =35 kg/m2)

7. preoperative serum albumin <30 g/L

8. anaerobic threshold (if done) <12 mL/kg/min

9. or two or more of the following risk factors:

- ASA 3 or 4

- chronic respiratory disease

- obesity (BMI 30-35 kg/m2)

- aortic or peripheral vascular disease

- preoperative Hb <100 g/L

- preoperative serum creatinine 150-199 micromol/L (>1.7 mg/dl)

- anerobic threshold (if done) 12-14 mL/kg/min
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Urgent or time-critical surgery

2. ASA physical status 5 - such patients are not expected to survive with or without
surgery, and their underlying illness is expected to have an overwhelming effect on
outcome (irrespective of fluid therapy)

3. Chronic renal failure requiring dialysis

4. Pulmonary or cardiac surgery - different pathophysiology, and thoracic surgery
typically have strict fluid restrictions

5. Liver resection - most units have strict fluid/CVP limits in place and won't allow
randomisation

6. Minor or intermediate surgery, such as laparoscopic cholecystectomy, transurethral
resection of the prostate, inguinal hernia repair, splenectomy, closure of colostomy -
each of these are typically "minor" surgery with minimal IV fluid requirements,
generally low rates of complications and mostly very good survival.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2021
Sample size
Target
Accrual to date
Final
3000
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Primary aim - To investigate the relationship between postoperative anaemia and
patient-centred outcomes after major abdominal surgery.

Secondary aim - To determine whether a more liberal perioperative IV fluid strategy increases
the risk of postoperative anaemia (haemodilution).

Hypothesis: Adults with anaemia in the immediate postoperative period following major
abdominal surgery have a poorer quality of recovery and higher risk of complications, leading
to poor disability-free survival when compared with patients without postoperative anaemia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04978285
Trial related presentations / publications
Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries