Restrictive vs Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur (RESULT-NOF)
Primary Purpose
Anemia, Cardiac Event, Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Administration of Red Cell
Sponsored by
About this trial
This is an interventional health services research trial for Anemia
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.
Sites / Locations
- Royal Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Restrictive
Liberal
Arm Description
Restrictive transfused when Hb at or below 70
Will receive blood transfusion when Hb drops below or equal to 90
Outcomes
Primary Outcome Measures
Myocardial Injury
Myocardial injury defined as a high sensitivity cardiac Troponin 1 (Troponin) concentration above the upper reference limit [URL] OF 16 ng L and 34 ng L in women and men respectively at any time during the study period.
Secondary Outcome Measures
Myocardial Infarction
Myocardial Infarction defined per the universal definition within 30 days of surgery or before hospital discharge, whichever occurs first.
Mortality
Mortality (30; 60 days from day of surgery).
Diagnosis of Major Adverse Cardiac Events
New diagnosis of MACE within 30 days of surgery or before hospital discharge, whichever occurs first.
Acute Kidney Injury
New diagnosis of Acute Kidney Injury
Infections
New diagnosis of Infectious Complications
Delirium
New diagnosis of Delirium
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03407573
Brief Title
Restrictive vs Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur
Acronym
RESULT-NOF
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Lothian
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Cardiac Event, Kidney Injury, Fractured Hip
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Restrictive
Arm Type
Active Comparator
Arm Description
Restrictive transfused when Hb at or below 70
Arm Title
Liberal
Arm Type
Active Comparator
Arm Description
Will receive blood transfusion when Hb drops below or equal to 90
Intervention Type
Biological
Intervention Name(s)
Administration of Red Cell
Intervention Description
Transfusion of red cells dependent on haemoglobin level. Either transfused at haemoglobin of 7 or 9.
Primary Outcome Measure Information:
Title
Myocardial Injury
Description
Myocardial injury defined as a high sensitivity cardiac Troponin 1 (Troponin) concentration above the upper reference limit [URL] OF 16 ng L and 34 ng L in women and men respectively at any time during the study period.
Time Frame
Upto 60 days
Secondary Outcome Measure Information:
Title
Myocardial Infarction
Description
Myocardial Infarction defined per the universal definition within 30 days of surgery or before hospital discharge, whichever occurs first.
Time Frame
within 30 days of surgery
Title
Mortality
Description
Mortality (30; 60 days from day of surgery).
Time Frame
upto 60 days following surgery
Title
Diagnosis of Major Adverse Cardiac Events
Description
New diagnosis of MACE within 30 days of surgery or before hospital discharge, whichever occurs first.
Time Frame
within 30 days or before hospital discharge
Title
Acute Kidney Injury
Description
New diagnosis of Acute Kidney Injury
Time Frame
within 30 days of surgery or before discharge from hospital whichever occurs first.
Title
Infections
Description
New diagnosis of Infectious Complications
Time Frame
within 30 days of surgery or before hospital discharge, whichever is first.
Title
Delirium
Description
New diagnosis of Delirium
Time Frame
within 30 days of surgery or before hospital discharge, whichever occurs first.
Other Pre-specified Outcome Measures:
Title
Troponin
Description
Peak troponin concentration
Time Frame
within 7 days of surgery (ngL )
Title
Troponin -Time
Description
Area under a Troponin-Time curve
Time Frame
within 7 days of surgery
Title
Red cells transfused
Description
Number of units red cells transfused
Time Frame
within7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.
Title
Volume in mls of Red Cells Transfused.
Description
Volume of red blood cells transfused in mls
Time Frame
within 7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.
Title
Haemoglobin postoperatively
Description
Postoperative Hb on postoperative days
Time Frame
days 1,3,5,7 after surgery
Title
Nadir Hb
Description
Nadir Hb
Time Frame
within 7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.
Title
Hospital Admission
Description
Duration of hospital admission (days)
Time Frame
from admission to discharge date from hospital upto 60 days.
Title
Readmission to hospital
Description
Incidence of unplanned hospital readmission within 60 days
Time Frame
upto 60 days of hospital discharge date
Title
Destination
Description
Discharge destination (home, other hospital, nursing home, other)
Time Frame
at Discharge from hospital with fractured hip upto 60 days of admission
Title
Health Related Quality of Life
Description
HRQoL at 60 days (EQ 5D)
Time Frame
at 60 days after surgery
Title
Costs
Description
Secondary care costs during 60 days post-randomisation in Great British Pound
Time Frame
60 days post randomisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Mike Gillies
Organizational Affiliation
Associate Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22791100
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.
Results Reference
background
PubMed Identifier
26349842
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.
Results Reference
result
PubMed Identifier
16632998
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.
Results Reference
result
PubMed Identifier
25805204
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.
Results Reference
result
PubMed Identifier
34932836
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.
Results Reference
derived
PubMed Identifier
32703548
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.
Results Reference
derived
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Restrictive vs Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur
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