Clinical trial NCT02969811: Cardiac Injury and Anaemia Following Surgery for Fractured Neck of Femur: An Observational Study Study Protocol: Cardiac Injury and Anaemia Following Surgery for Fractured Neck of Femur
Official title: Cardiac Injury and Anaemia Following Surgery for Fractured Neck of Femur: An Observational Study Study Protocol: Cardiac Injury and Anaemia Following Surgery for Fractured Neck of Femur: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaemia, Myocardial Ischaemia, Fractured Neck of Femur
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2016-11-21
Enrollment: 47
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have suffered fractured neck of femur.

Brief summary: Blood transfusion is an expensive and finite resource and optimum transfusion threshold in surgical patients is yet to be defined. Patients commonly receive blood transfusions to reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the kidneys), but this treatment may have important adverse effects including postoperative infection. Patients undergoing surgery for fractured neck of femur are often elderly, with co-morbidities and a high risk of postoperative complications, including MI and AKI. We propose to conduct a study with the following aims:

1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for fractured neck of femur.
2. To use clinical and biochemical data to measure the incidence of perioperative cardiac and kidney injury in this group.
3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints in a future prospective randomised trial of perioperative transfusion.

Detailed description: Blood transfusion is an expensive and finite resource and optimum transfusion threshold in surgical patients is yet to be defined. Patients commonly receive blood transfusions to reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the kidneys), but this treatment may have important adverse effects including postoperative infection. There is great interest in restrictive transfusion practices (e.g. a transfusion trigger of 70 g L-1), however patients with co-existing cardiovascular disease have been excluded from studies of restrictive versus liberal transfusion strategies. Highly sensitive troponin assays are now available, which allow clinicians to reliably detect cardiac injury in increased numbers of patients who have undergone major surgery. Troponin release after surgery is common, as high as 40% in some studies. Patients undergoing surgery for fractured neck of femur are often elderly, with co-morbidities and a high risk of postoperative complications, including MI and AKI. We propose to conduct a study with the following aims:

1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for fractured neck of femur.
2. To use clinical and biochemical data to measure the incidence of perioperative cardiac and kidney injury in this group.
3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints in a future prospective randomised trial of perioperative transfusion.

Eligibility criteria: Inclusion Criteria:

* Fractured Neck of Femur
* Age \>50
* Informed consent

Exclusion Criteria:

* refusal of consent

Primary outcomes:
measure: Cardiac Injury
timeFrame: 72 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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