An interventional study of Administration of Red Cell in Anemia, Cardiac Event and Kidney Injury, sponsored by NHS Lothian. Completed at 1 site in United Kingdom. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-03-11.
Sponsored by NHS Lothian · Not applicable, Interventional, and Health services research
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.
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.
Inclusion Criteria:Adults aged over 50 years Within 48 hours of admission to hospital with fractured Neck of Femur. Exclusion Criteria: Age \<50
Restrictive transfused when Hb at or below 70
Biological: Administration of Red Cell
Will receive blood transfusion when Hb drops below or equal to 90
Biological: Administration of Red Cell
Transfusion of red cells dependent on haemoglobin level. Either transfused at haemoglobin of 7 or 9.
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.
Time frame: Upto 60 days
Myocardial Infarction
Myocardial Infarction defined per the universal definition within 30 days of surgery or before hospital discharge, whichever occurs first.
Time frame: within 30 days of surgery
Mortality
Mortality (30; 60 days from day of surgery).
Time frame: 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.
Time frame: within 30 days or before hospital discharge
Acute Kidney Injury
New diagnosis of Acute Kidney Injury
Time frame: within 30 days of surgery or before discharge from hospital whichever occurs first.
Infections
New diagnosis of Infectious Complications
Time frame: within 30 days of surgery or before hospital discharge, whichever is first.
Delirium
New diagnosis of Delirium
Time frame: within 30 days of surgery or before hospital discharge, whichever occurs first.
Troponin
Peak troponin concentration
Time frame: within 7 days of surgery (ngL )
Troponin -Time
Area under a Troponin-Time curve
Time frame: within 7 days of surgery
Red cells transfused
Number of units red cells transfused
Time frame: within7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.
Volume in mls of Red Cells Transfused.
Volume of red blood cells transfused in mls
Time frame: within 7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.
Haemoglobin postoperatively
Postoperative Hb on postoperative days
Time frame: days 1,3,5,7 after surgery
Nadir Hb
Nadir Hb
Time frame: within 7 days of surgery and within 30 days of surgery or before hospital discharge, whichever occurs first.
Hospital Admission
Duration of hospital admission (days)
Time frame: from admission to discharge date from hospital upto 60 days.
Readmission to hospital
Incidence of unplanned hospital readmission within 60 days
Time frame: upto 60 days of hospital discharge date
Destination
Discharge destination (home, other hospital, nursing home, other)
Time frame: at Discharge from hospital with fractured hip upto 60 days of admission
Health Related Quality of Life
HRQoL at 60 days (EQ 5D)
Time frame: at 60 days after surgery
Costs
Secondary care costs during 60 days post-randomisation in Great British Pound
Time frame: 60 days post randomisation
Plan to share: No
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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