Clinical trial NCT03407573: Restrictive vs Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur
Official title: The Impact of Restrictive Versus Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Cardiac Event
Kidney Injury
Fractured Hip
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2018-01-23
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigator wishes to see if it is possible to undertake a study comparing blood transfusion at two different levels of anaemia to see which is best for patients. All patients that present to hospital with a broken hip will be able to take part in the study. If they become anaemic during their treatment they will be allocated to either be transfused when their blood count is less that 9 or less than 7. In all patients, we will measure heart damage with a blood test that is very sensitive. The investigator will also collect data on the incidence of heart attacks and other complications.

Detailed description: Many frail and elderly patients undergo surgery for hip fractures every year. Many of these patients have other health problems including heart disease and anaemia (low haemoglobin or "low blood count") either from chronic illness, from bleeding at the time of their injury or during subsequent surgery. The vast majority (more than 95%) of these patients will go on to have surgery. This surgery is often high risk. Patients with this type of injury may already be frail, may be in hospital for a long time and will need rehabilitation. Many of them will develop complications, including heart attacks and some will die.

Doctors looking after these patients commonly prescribe a blood transfusion around the time of surgery. These patient often have anaemia before surgery an lose more blood during their operations. A benefit of blood transfusion is that it may increase the amount of oxygen the blood can carry. One of the main reasons that doctors prescribe blood around the time of surgery is to prevent heart attacks, which can occur if the heart doesn't receive enough oxygen. Another possible benefit of blood transfusion is that it may help patients get out of bed more quickly after surgery. This is another important aspect of their recovery.

However, blood transfusions can have side effects such as causing heart failure or increasing infections after surgery. These can delay patient recovery too. Although some research has been done in this area, anaesthetists and surgeons are still unsure of when to prescribe blood transfusions to these patients. In particular, uncertainty about how low the blood count should be before a blood transfusion is ordered. Some doctors prescribe blood when the haemoglobin count is less than 9 and some at a lower level of 7. Current guidelines suggest that prescribing at a lower haemoglobin count is better, but there is research which suggests that this level is too low if the patient has a history of heart disease.

Eligibility criteria: Inclusion Criteria:Adults aged over 50 years Within 48 hours of admission to hospital with fractured Neck of Femur. Exclusion Criteria: Age \<50

* Refusal of consent of patient (or consultee) Patient for palliative care.

Primary outcomes:
measure: Myocardial Injury
timeFrame: Upto 60 days
Secondary outcomes:
measure: Myocardial Infarction
timeFrame: within 30 days of surgery
measure: Mortality
timeFrame: upto 60 days following surgery
measure: Diagnosis of Major Adverse Cardiac Events
timeFrame: within 30 days or before hospital discharge
measure: Acute Kidney Injury
timeFrame: within 30 days of surgery or before discharge from hospital whichever occurs first.
measure: Infections
timeFrame: within 30 days of surgery or before hospital discharge, whichever is first.
measure: Delirium
timeFrame: within 30 days of surgery or before hospital discharge, whichever occurs first.
Other outcomes:
measure: Troponin
timeFrame: within 7 days of surgery (ngL )
measure: Troponin -Time
timeFrame: within 7 days of surgery
measure: Red cells transfused
timeFrame: within7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.
measure: Volume in mls of Red Cells Transfused.
timeFrame: within 7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.
measure: Haemoglobin postoperatively
timeFrame: days 1,3,5,7 after surgery
measure: Nadir Hb
timeFrame: within 7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.
measure: Hospital Admission
timeFrame: from admission to discharge date from hospital upto 60 days.
measure: Readmission to hospital
timeFrame: upto 60 days of hospital discharge date
measure: Destination
timeFrame: at Discharge from hospital with fractured hip upto 60 days of admission
measure: Health Related Quality of Life
timeFrame: at 60 days after surgery
measure: Costs
timeFrame: 60 days post randomisation
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
Study officials:
affiliation: Associate Medical Director
name: Dr.Mike Gillies
role: PRINCIPAL_INVESTIGATOR
References:
citation: Acheson AG, Brookes MJ, Spahn DR. Effects of allogeneic red blood cell transfusions on clinical outcomes in patients undergoing colorectal cancer surgery: a systematic review and meta-analysis. Ann Surg. 2012 Aug;256(2):235-44. doi: 10.1097/SLA.0b013e31825b35d5.
citation: Fowler AJ, Ahmad T, Phull MK, Allard S, Gillies MA, Pearse RM. Meta-analysis of the association between preoperative anaemia and mortality after surgery. Br J Surg. 2015 Oct;102(11):1314-24. doi: 10.1002/bjs.9861.
citation: Davenport DL, Bowe EA, Henderson WG, Khuri SF, Mentzer RM Jr. National Surgical Quality Improvement Program (NSQIP) risk factors can be used to validate American Society of Anesthesiologists Physical Status Classification (ASA PS) levels. Ann Surg. 2006 May;243(5):636-41; discussion 641-4. doi: 10.1097/01.sla.0000216508.95556.cc.
citation: Holst LB, Petersen MW, Haase N, Perner A, Wetterslev J. Restrictive versus liberal transfusion strategy for red blood cell transfusion: systematic review of randomised trials with meta-analysis and trial sequential analysis. BMJ. 2015 Mar 24;350:h1354. doi: 10.1136/bmj.h1354.
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
citation: Gillies MA, Ghaffar S, Moppett IK, Docherty AB, Clarke S, Rea N, Stephen J, Keerie C, Ray DC, White TO, MacLullich AMJ, Mills NM, Rowley MR, Murthy K, Pearse RM, Stanworth SJ, Walsh TS. A restrictive versus liberal transfusion strategy to prevent myocardial injury in patients undergoing surgery for fractured neck of femur: a feasibility randomised trial (RESULT-NOF). Br J Anaesth. 2021 Jan;126(1):77-86. doi: 10.1016/j.bja.2020.06.048. Epub 2020 Jul 21.