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

Anaemia, Myocardial Ischaemia, Fractured Neck of Femur Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02969811
• Other study ID #: AC16087
• Status: Not yet recruiting
• Phase: N/A
• First received: November 18, 2016
• Last updated: November 18, 2016
• Start date: December 2016
• Est. completion date: March 2018

Study information

• Verified date: November 2016
• Source: NHS Lothian
• Contact: Michael A Gillies, MD
• Phone: 0131 242 3193
• Email: Michael.Gillies[@]nhslothian.scot.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Fractured Neck of Femur

• Age >50

• Informed consent

Exclusion Criteria:

• refusal of consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anaemia, Myocardial Ischaemia, Fractured Neck of Femur
• Anemia
• Coronary Artery Disease
• Femoral Neck Fractures
• Fractures, Bone
• Ischemia
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NHS Lothian

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Injury	Serum Troponin above upper reference limit	72 hours after surgery	No