Restrictive vs Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur

Anemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407573
• Other study ID #: WKRO-2016-0018
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: March 2018
• Source: NHS Lothian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Anemia
• Cardiac Event
• Femoral Neck Fractures
• Fractured Hip
• Fractures, Bone
• Kidney Injury
• Wounds and Injuries

Intervention

Biological:
• Administration of Red Cell
Transfusion of red cells dependent on haemoglobin level. Either transfused at haemoglobin of 7 or 9.

Locations

Country	Name	City	State
United Kingdom	Royal Hospital for Sick Children	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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

Outcome

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.