Anemia, Cardiac Event, Fractured Hip, Kidney Injury
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALAdministration of Red Cell
Transfusion of red cells dependent on haemoglobin level. Either transfused at haemoglobin of 7 or 9.
Sponsors
NHS Lothian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Injury | Upto 60 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | upto 60 days following surgery | Mortality (30; 60 days from day of surgery). |
| Diagnosis of Major Adverse Cardiac Events | within 30 days or before hospital discharge | New diagnosis of MACE within 30 days of surgery or before hospital discharge, whichever occurs first. |
| Myocardial Infarction | within 30 days of surgery | Myocardial Infarction defined per the universal definition within 30 days of surgery or before hospital discharge, whichever occurs first. |
| Infections | within 30 days of surgery or before hospital discharge, whichever is first. | New diagnosis of Infectious Complications |
| Delirium | within 30 days of surgery or before hospital discharge, whichever occurs first. | New diagnosis of Delirium |
| Acute Kidney Injury | within 30 days of surgery or before discharge from hospital whichever occurs first. | New diagnosis of Acute Kidney Injury |
Other
| Measure | Time frame | Description |
|---|---|---|
| Readmission to hospital | upto 60 days of hospital discharge date | Incidence of unplanned hospital readmission within 60 days |
| Destination | at Discharge from hospital with fractured hip upto 60 days of admission | Discharge destination (home, other hospital, nursing home, other) |
| Troponin | within 7 days of surgery (ngL ) | Peak troponin concentration |
| Costs | 60 days post randomisation | Secondary care costs during 60 days post-randomisation in Great British Pound |
| Health Related Quality of Life | at 60 days after surgery | HRQoL at 60 days (EQ 5D) |
| Troponin -Time | within 7 days of surgery | Area under a Troponin-Time curve |
| Red cells transfused | within7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first. | Number of units red cells transfused |
| Volume in mls of Red Cells Transfused. | within 7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first. | Volume of red blood cells transfused in mls |
| Haemoglobin postoperatively | days 1,3,5,7 after surgery | Postoperative Hb on postoperative days |
| Nadir Hb | within 7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first. | Nadir Hb |
| Hospital Admission | from admission to discharge date from hospital upto 60 days. | Duration of hospital admission (days) |
Countries
United Kingdom
Outcome results
None listed