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NCT Number: 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

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.

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Key information

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Fractured Neck of Femur
  • Age >50
  • Informed consent

Exclusion criteria

  • refusal of consent

Treatment and study plan

Primary outcomes

  1. Cardiac Injury

    Time frame: 72 hours after surgery

    Serum Troponin above upper reference limit

Sponsors and collaborators

Lead sponsor

NHS Lothian

Other Gov

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2016
Registry last updated
Sep 24, 2024

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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