- ICH GCP
- US Clinical Trials Registry
- 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
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
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:
- 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.
Study Overview
Status
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:
- 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Michael A Gillies, MD
- Phone Number: 0131 242 3193
- Email: Michael.Gillies@nhslothian.scot.nhs.uk
Study Contact Backup
- Name: Alastair Lang, RN
- Phone Number: 0131 536 1000
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Fractured Neck of Femur
- Age >50
- Informed consent
Exclusion Criteria:
- refusal of consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Injury
Time Frame: 72 hours after surgery
|
Serum Troponin above upper reference limit
|
72 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC16087
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anaemia, Myocardial Ischaemia, Fractured Neck of Femur
-
Cork University HospitalUniversity of BristolUnknown
-
Royal Berkshire NHS Foundation TrustDePuy InternationalSuspendedFractured Neck of FemurUnited Kingdom
-
Cork University HospitalCompletedFractured Neck of FemurIreland
-
Cork University HospitalCompletedMinimum Effective Dose of Local Anaesthetic With FentanylIreland
-
NHS LothianCompletedAnemia | Kidney Injury | Cardiac Event | Fractured HipUnited Kingdom
-
Princess Alexandra Hospital, Brisbane, AustraliaCompletedFractured Neck of Femur
-
University of MelbourneMelbourne Health; Austin HealthCompletedHip FracturesAustralia
-
Norwegian University of Science and TechnologyThe Research Council of Norway; Helse Nord-Trøndelag HFCompletedHip Fracture | Aged
-
Cork University HospitalCompletedPostoperative Pain | Fractured Neck of FemurIreland
-
Brno University HospitalSt. Anne's University Hospital Brno, Czech RepublicCompletedFracture of Neck of Femur (Hip)Czech Republic