Restrictive vs Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur

Study Overview
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Brief Summary
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The investigator wishes to see if it is possible to undertake a study comparing blood transfusion at two different levels of anaemia to see which is best for patients. All patients that present to hospital with a broken hip will be able to take part in the study. If they become anaemic during their treatment they will be allocated to either be transfused when their blood count is less that 9 or less than 7. In all patients, we will measure heart damage with a blood test that is very sensitive. The investigator will also collect data on the incidence of heart attacks and other complications.

Detailed Description
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Many frail and elderly patients undergo surgery for hip fractures every year. Many of these patients have other health problems including heart disease and anaemia (low haemoglobin or low blood count) either from chronic illness, from bleeding at the time of their injury or during subsequent surgery. The vast majority (more than 95%) of these patients will go on to have surgery. This surgery is often high risk. Patients with this type of injury may already be frail, may be in hospital for a long time and will need rehabilitation. Many of them will develop complications, including heart attacks and some will die. Doctors looking after these patients commonly prescribe a blood transfusion around the time of surgery. These patient often have anaemia before surgery an lose more blood during their operations. A benefit of blood transfusion is that it may increase the amount of oxygen the blood can carry. One of the main reasons that doctors prescribe blood around the time of surgery is to prevent heart attacks, which can occur if the heart doesn't receive enough oxygen. Another possible benefit of blood transfusion is that it may help patients get out of bed more quickly after surgery. This is another important aspect of their recovery. However, blood transfusions can have side effects such as causing heart failure or increasing infections after surgery. These can delay patient recovery too. Although some research has been done in this area, anaesthetists and surgeons are still unsure of when to prescribe blood transfusions to these patients. In particular, uncertainty about how low the blood count should be before a blood transfusion is ordered. Some doctors prescribe blood when the haemoglobin count is less than 9 and some at a lower level of 7. Current guidelines suggest that prescribing at a lower haemoglobin count is better, but there is research which suggests that this level is too low if the patient has a history of heart disease.

Official Title
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The Impact of Restrictive Versus Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur Study

Conditions
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Anemia, Cardiac Event, Kidney Injury, Fractured Hip

Intervention / Treatment
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* Biological: Administration of Red Cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Adults aged over 50 years Within 48 hours of admission to hospital with fractured Neck of Femur. Exclusion Criteria: Age <50 Refusal of consent of patient (or consultee) Patient for palliative care.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Restrictive<br>Restrictive transfused when Hb at or below 70 | Biological: Administration of Red Cell<br>* Transfusion of red cells dependent on haemoglobin level. Either transfused at haemoglobin of 7 or 9.<br>|
| Active Comparator: Liberal<br>Will receive blood transfusion when Hb drops below or equal to 90 | Biological: Administration of Red Cell<br>* Transfusion of red cells dependent on haemoglobin level. Either transfused at haemoglobin of 7 or 9.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Injury | Myocardial injury defined as a high sensitivity cardiac Troponin 1 (Troponin) concentration above the upper reference limit [URL] OF 16 ng L and 34 ng L in women and men respectively at any time during the study period. | Upto 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Infarction | Myocardial Infarction defined per the universal definition within 30 days of surgery or before hospital discharge, whichever occurs first. | within 30 days of surgery | 
| Mortality | Mortality (30; 60 days from day of surgery). | upto 60 days following surgery | 
| Diagnosis of Major Adverse Cardiac Events | New diagnosis of MACE within 30 days of surgery or before hospital discharge, whichever occurs first. | within 30 days or before hospital discharge | 
| Acute Kidney Injury | New diagnosis of Acute Kidney Injury | within 30 days of surgery or before discharge from hospital whichever occurs first. | 
| Infections | New diagnosis of Infectious Complications | within 30 days of surgery or before hospital discharge, whichever is first. | 
| Delirium | New diagnosis of Delirium | within 30 days of surgery or before hospital discharge, whichever occurs first. |