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Clinical Trials/NCT02969811
NCT02969811
Unknown
Not Applicable

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

NHS Lothian0 sites200 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anaemia, Myocardial Ischaemia, Fractured Neck of Femur
Sponsor
NHS Lothian
Enrollment
200
Primary Endpoint
Cardiac Injury
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
March 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Fractured Neck of Femur
  • Informed consent

Exclusion Criteria

  • refusal of consent

Outcomes

Primary Outcomes

Cardiac Injury

Time Frame: 72 hours after surgery

Serum Troponin above upper reference limit

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