Anaemia, Myocardial Ischaemia, Fractured Neck of FemurNCT02969811
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 of Anaemia, Myocardial Ischaemia, Fractured Neck of Femur, run by NHS Lothian.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Anaemia, Myocardial Ischaemia, Fractured Neck of Femur
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have suffered fractured neck of femur.
Who may be able to join
- Fractured Neck of Femur
- Age >50
- Informed consent
Who cannot join
- refusal of consent
About this study
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
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.
Read the 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.
- Medical subject headings
- Anemia, Coronary Artery Disease, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severely Anaemic | Patients with Hb 90 g/L or less | |
| Non-Anaemic | Patients with Hb greater than 90 g/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Injury
Serum Troponin above upper reference limit
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start1 Jan 2017
- Primary completion30 Apr 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaemia, Myocardial Ischaemia, Fractured Neck of FemurStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969811
- Sponsor's protocol ID
- AC16087
- Status last verified
- Nov 2016
- First submitted
- 18 Nov 2016
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02969811
- Acronym / sponsor ID
- AC16087
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severely Anaemic | – | –Patients with Hb 90 g/L or less |
| Non-Anaemic | – | –Patients with Hb greater than 90 g/L |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have suffered fractured neck of femur.
Key inclusion criteria (3 listed)
- Fractured Neck of Femur
- Age >50
- Informed consent
Key exclusion criteria (1 listed)
- refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac Injury
Time frame: 72 hours after surgery
Serum Troponin above upper reference limit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaemia, Myocardial Ischaemia, Fractured Neck of Femur, run by NHS Lothian.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Injury (time frame: 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.