Anemia After SurgeryNCT04978285
Association of Postoperative Anaemia With Patient-centred Outcomes
An observational study of Anemia After Surgery, run by Bayside Health at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia After Surgery
- What is being tested?
- Anemia
- How many people
- 3,000 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Jul 2021to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, elective major abdominal surgery
Who may be able to join
- Adults (≥18 years) undergoing elective major surgery and providing informed consent
- 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
- At increased risk of postoperative complications, as defined by any of the following criteria:
- age ≥70 years
- known or documented history of coronary artery disease
- known or documented history of heart failure
Show all 19Show fewer
- diabetes currently treated with an oral hypoglycemic agent and/or insulin
- preoperative serum creatinine >200 micromol/L (>2.8 mg/dl)
- morbid obesity (BMI ≥35 kg/m2)
- preoperative serum albumin <30 g/L
- anaerobic threshold (if done) <12 mL/kg/min
- 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
Who cannot join
- Urgent or time-critical surgery
- 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)
- Chronic renal failure requiring dialysis
- Pulmonary or cardiac surgery - different pathophysiology, and thoracic surgery typically have strict fluid restrictions
- Liver resection - most units have strict fluid/CVP limits in place and won't allow randomisation
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The consequences of postoperative anemia remain unclear. Postoperative anaemia is more likely if there is pre-existing anemia, but also increased perioperative blood loss, frequent blood sampling, excess IV fluids (leading to hemodilution), sepsis, and inadequate nutritional intake after surgery. A nadir in Hb concentration is most often observed within the first 3-4 days after surgery. Postoperative anemia is believed to have deleterious effects on patient outcomes, including prolonged hospital stay, increased postoperative complications, and perhaps poor survival, but there is very little data to support this belief.
A recent consensus statement suggested that all patients recovering from major surgery (defined as blood loss > 500 ml or lasting > 2 h) and either had preoperative anemia or moderate-to-severe blood loss during surgery must be screened for anemia after surgery. Furthermore, this consensus group recommended that patients recovering from uncomplicated major surgery should have their Hb concentration measured for at least 3 days after surgery to detect anemia. As outlined above, this is problematic if there is fluid retention.
The role of IV iron for the treatment of postoperative anemia is unclear, with the most recent systematic review concluding that neither oral nor IV iron had a significant effect on patient quality of life or functional outcomes following surgery. A diagnosis of iron deficiency is very difficult in the postoperative period because the acute phase inflammatory response results in spuriously elevated ferritin levels, and several studies have demonstrated oral iron therapy is ineffective in this setting.
The investigators propose a study to investigate the incidence, extent, and outcomes of patients with anemia after major surgery, including an assessment of the amount of IV fluids administered in the immediate perioperative period.
- Conditions
- Anemia After Surgery
- Being tested
- Anemia
- Keywords
- anemia, complications, hemoglobin, iron, patient-centered outcome, surgery
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnemiaOther
Also called Observational
Depends on Day 3 Hb result
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Anemia | |
| 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). Receives: Other: Anemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent disability or death by 90 days
Defined as a World Health Organization Disability Assessment Schedule 2.0 (WHODAS) score of at least 24 points (on the 48-point scale) at both 30 and 90 days postoperatively, reflecting a disability level of at least 25% and being the threshold point between "disabled" and "not disabled" as per WHO guidelines. Disability was assessed by the participant, but if unable then we used the proxy's report.
Measured: 90 days after surgery
Secondary outcomes (12)
Death: all-cause mortality at 90 days, then up to 12 months after surgery
Measured: 1 year
A composite (pooled) and individual septic complications: sepsis, surgical site infection, anastomotic leak, and pneumonia
Measured: 30 days
Sepsis: using Centers for Disease Control and Prevention (CDC) with National Healthcare Safety Network (NHSN) criteria
Measured: 30 days
Surgical site infection
CDC criteria
Measured: 30 days
Pneumonia
The presence of new and/or progressive pulmonary infiltrates on chest radiograph plus two or more of the following:
- Fever ≥ 38.5°C or postoperative hypothermia <36°C ii. Leucocytosis ≥ 12,000 WBC/mm3 or leucopenia < 4,000 WBC/mm3 iii. Purulent sputum and/or iv. New onset or worsening cough or dyspnea.
Measured: 30 days
Anastomotic leak
A defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- an extra luminal compartments.
Measured: 30 days
Acute kidney injury
According to The Kidney Disease: Improving Global Outcomes (KDIGO) group criteria, but not urine output - for Stage 2 or worse AKI defined as at least 2-fold increase in creatinine, or estimated GFR decrease >50%
Measured: 30 days
Unplanned admission to ICU within 30 days of surgery
Measured: 30 days
ICU stay
Total days - additive, including initial ICU admission and readmission times up to Day 30
Measured: 30 days
Hospital stay
Total -additive, from the start (date, time) of surgery until actual hospital discharge , plus readmission(s) up to Day 30
Measured: 30 days
Quality of recovery
QoR-15 scale score
Measured: Postoperative Days 3 and 30
Hospital re-admission
Measured: At 3, 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start16 Jul 2021
- Primary completion31 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anemia After SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Monash University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978285
- Sponsor's protocol ID
- 544/12
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Consider, on request
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.
PubMed 29742967Myles PS, Richards T, Klein A, Wood EM, Wallace S, Shulman MA, Martin C, Bellomo R, Corcoran TB, Peyton PJ, Story DA, Leslie K, Forbes A; RELIEF Trial Investigators. Postoperative anaemia and patient-centred outcomes after major abdominal surgery: a retrospective cohort study. Br J Anaesth. 2022 Sep;129(3):346-354. doi: 10.1016/j.bja.2022.06.014. Epub 2022 Jul 15.
PubMed 35843746
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Postoperative Anaemia With Patient-centred Outcomes
- ClinicalTrials.gov ID
- NCT04978285
- Acronym / sponsor ID
- 544/12
- Conditions
- Anemia After Surgery
- Keywords
- anemia, complications, hemoglobin, iron, patient-centered outcome, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Monash University
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The consequences of postoperative anemia remain unclear. Postoperative anaemia is more likely if there is pre-existing anemia, but also increased perioperative blood loss, frequent blood sampling, excess IV fluids (leading to hemodilution), sepsis, and inadequate nutritional intake after surgery. A nadir in Hb concentration is most often observed within the first 3-4 days after surgery. Postoperative anemia is believed to have deleterious effects on patient outcomes, including prolonged hospital stay, increased postoperative complications, and perhaps poor survival, but there is very little data to support this belief.
A recent consensus statement suggested that all patients recovering from major surgery (defined as blood loss > 500 ml or lasting > 2 h) and either had preoperative anemia or moderate-to-severe blood loss during surgery must be screened for anemia after surgery. Furthermore, this consensus group recommended that patients recovering from uncomplicated major surgery should have their Hb concentration measured for at least 3 days after surgery to detect anemia. As outlined above, this is problematic if there is fluid retention.
The role of IV iron for the treatment of postoperative anemia is unclear, with the most recent systematic review concluding that neither oral nor IV iron had a significant effect on patient quality of life or functional outcomes following surgery. A diagnosis of iron deficiency is very difficult in the postoperative period because the acute phase inflammatory response results in spuriously elevated ferritin levels, and several studies have demonstrated oral iron therapy is ineffective in this setting.
The investigators propose a study to investigate the incidence, extent, and outcomes of patients with anemia after major surgery, including an assessment of the amount of IV fluids administered in the immediate perioperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative anemia | – | Other: AnemiaAll 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 | – | Other: AnemiaAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, elective major abdominal surgery
Key inclusion criteria (19 listed)
- Adults (≥18 years) undergoing elective major surgery and providing informed consent
- 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
- At increased risk of postoperative complications, as defined by any of the following criteria:
Key exclusion criteria (6 listed)
- Urgent or time-critical surgery
- 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)
- Chronic renal failure requiring dialysis
- Pulmonary or cardiac surgery - different pathophysiology, and thoracic surgery typically have strict fluid restrictions
- Liver resection - most units have strict fluid/CVP limits in place and won't allow randomisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnemiaAlso: ObservationalDepends on Day 3 Hb result | Other | No postoperative anemia, Postoperative anemia |
Primary outcome
Persistent disability or death by 90 days
Time frame: 90 days after surgery
Defined as a World Health Organization Disability Assessment Schedule 2.0 (WHODAS) score of at least 24 points (on the 48-point scale) at both 30 and 90 days postoperatively, reflecting a disability level of at least 25% and being the threshold point between "disabled" and "not disabled" as per WHO guidelines. Disability was assessed by the participant, but if unable then we used the proxy's report.
12 secondary outcomes
Death: all-cause mortality at 90 days, then up to 12 months after surgery
Time frame: 1 year
A composite (pooled) and individual septic complications: sepsis, surgical site infection, anastomotic leak, and pneumonia
Time frame: 30 days
Sepsis: using Centers for Disease Control and Prevention (CDC) with National Healthcare Safety Network (NHSN) criteria
Time frame: 30 days
Surgical site infection
Time frame: 30 days
Pneumonia
Time frame: 30 days
Anastomotic leak
Time frame: 30 days
Acute kidney injury
Time frame: 30 days
Unplanned admission to ICU within 30 days of surgery
Time frame: 30 days
ICU stay
Time frame: 30 days
Hospital stay
Time frame: 30 days
Quality of recovery
Time frame: Postoperative Days 3 and 30
Hospital re-admission
Time frame: At 3, 6 and 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Background: PubMed 29742967Myles 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.
- Derived from this study: PubMed 35843746Myles PS, Richards T, Klein A, Wood EM, Wallace S, Shulman MA, Martin C, Bellomo R, Corcoran TB, Peyton PJ, Story DA, Leslie K, Forbes A; RELIEF Trial Investigators. Postoperative anaemia and patient-centred outcomes after major abdominal surgery: a retrospective cohort study. Br J Anaesth. 2022 Sep;129(3):346-354. doi: 10.1016/j.bja.2022.06.014. Epub 2022 Jul 15.
- Individual participant dataSharing planned: Undecided. Consider, on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia After Surgery, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent disability or death by 90 days (time frame: 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04978285, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.