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NCT Number: NCT03407573

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Hospital for Sick Children

Edinburgh, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Administration of Red Cell

Biological

Transfusion of red cells dependent on haemoglobin level. Either transfused at haemoglobin of 7 or 9.

Primary outcomes

  1. Myocardial Injury

    Time frame: Upto 60 days

    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 outcomes

  1. Myocardial Infarction

    Time frame: within 30 days of surgery

    Myocardial Infarction defined per the universal definition within 30 days of surgery or before hospital discharge, whichever occurs first.

  2. Mortality

    Time frame: upto 60 days following surgery

    Mortality (30; 60 days from day of surgery).

  3. Diagnosis of Major Adverse Cardiac Events

    Time frame: within 30 days or before hospital discharge

    New diagnosis of MACE within 30 days of surgery or before hospital discharge, whichever occurs first.

  4. Acute Kidney Injury

    Time frame: within 30 days of surgery or before discharge from hospital whichever occurs first.

    New diagnosis of Acute Kidney Injury

  5. Infections

    Time frame: within 30 days of surgery or before hospital discharge, whichever is first.

    New diagnosis of Infectious Complications

  6. Delirium

    Time frame: within 30 days of surgery or before hospital discharge, whichever occurs first.

    New diagnosis of Delirium

Other outcomes

  1. Troponin

    Time frame: within 7 days of surgery (ngL )

    Peak troponin concentration

  2. Troponin -Time

    Time frame: within 7 days of surgery

    Area under a Troponin-Time curve

  3. Red cells transfused

    Time frame: within7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.

    Number of units red cells transfused

  4. Volume in mls of Red Cells Transfused.

    Time frame: within 7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.

    Volume of red blood cells transfused in mls

  5. Haemoglobin postoperatively

    Time frame: days 1,3,5,7 after surgery

    Postoperative Hb on postoperative days

  6. Nadir Hb

    Time frame: within 7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.

    Nadir Hb

  7. Hospital Admission

    Time frame: from admission to discharge date from hospital upto 60 days.

    Duration of hospital admission (days)

  8. Readmission to hospital

    Time frame: upto 60 days of hospital discharge date

    Incidence of unplanned hospital readmission within 60 days

  9. Destination

    Time frame: at Discharge from hospital with fractured hip upto 60 days of admission

    Discharge destination (home, other hospital, nursing home, other)

  10. Health Related Quality of Life

    Time frame: at 60 days after surgery

    HRQoL at 60 days (EQ 5D)

  11. Costs

    Time frame: 60 days post randomisation

    Secondary care costs during 60 days post-randomisation in Great British Pound

Sponsors and collaborators

Lead sponsor

NHS Lothian

Other Gov

Registry information

Official study title

The Impact of Restrictive Versus Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur Study

Acronym: RESULT-NOF

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2018
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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