Anemia Clinical Trial
— RESULT-NOFOfficial title:
The Impact of Restrictive Versus Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur Study
Verified date | March 2018 |
Source | NHS Lothian |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | June 1, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Hospital for Sick Children | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
NHS Lothian |
United Kingdom,
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. Review. — View 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 M — View 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. Review. — View 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. do — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Troponin | Peak troponin concentration | within 7 days of surgery (ngL ) | |
Other | Troponin -Time | Area under a Troponin-Time curve | within 7 days of surgery | |
Other | Red cells transfused | Number of units red cells transfused | within7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first. | |
Other | Volume in mls of Red Cells Transfused. | Volume of red blood cells transfused in mls | within 7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first. | |
Other | Haemoglobin postoperatively | Postoperative Hb on postoperative days | days 1,3,5,7 after surgery | |
Other | Nadir Hb | Nadir Hb | within 7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first. | |
Other | Hospital Admission | Duration of hospital admission (days) | from admission to discharge date from hospital upto 60 days. | |
Other | Readmission to hospital | Incidence of unplanned hospital readmission within 60 days | upto 60 days of hospital discharge date | |
Other | Destination | Discharge destination (home, other hospital, nursing home, other) | at Discharge from hospital with fractured hip upto 60 days of admission | |
Other | Health Related Quality of Life | HRQoL at 60 days (EQ 5D) | at 60 days after surgery | |
Other | Costs | Secondary care costs during 60 days post-randomisation in Great British Pound | 60 days post randomisation | |
Primary | 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. | Upto 60 days | |
Secondary | Myocardial Infarction | Myocardial Infarction defined per the universal definition within 30 days of surgery or before hospital discharge, whichever occurs first. | within 30 days of surgery | |
Secondary | Mortality | Mortality (30; 60 days from day of surgery). | upto 60 days following surgery | |
Secondary | Diagnosis of Major Adverse Cardiac Events | New diagnosis of MACE within 30 days of surgery or before hospital discharge, whichever occurs first. | within 30 days or before hospital discharge | |
Secondary | Acute Kidney Injury | New diagnosis of Acute Kidney Injury | within 30 days of surgery or before discharge from hospital whichever occurs first. | |
Secondary | Infections | New diagnosis of Infectious Complications | within 30 days of surgery or before hospital discharge, whichever is first. | |
Secondary | Delirium | New diagnosis of Delirium | within 30 days of surgery or before hospital discharge, whichever occurs first. |
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