To assess whether increasing low hemoglobin levels to near normal accelerate functional recovery and shorten the revalidation period after hip fracture surgery in the elderly.
ID
Source
Brief title
Condition
- Haematological disorders NEC
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the number of days of admittance in the hospital
counted from the first day of the hip surgery until the day of discharge or the
day that the patient for medical reasons could have been discharged but due to
external factors, like *no help at home* or no rehabilitation space available,
has to stay in the hospital (the so called *wrong bed patient*). The day of
discharge is determined by the functional performance of the patient and the
ability to perform (almost) independency for daily activities.
Secondary outcome
Secondary outcomes are the following functional measurements:
In hospital mortality, place of residence after hospital discharge, and in
hospital complications like delirium, infections or cardiovascular events.
Background summary
Hip fractures are a main cause of morbidity and mortality in the elderly
population, and numbers are expected to increase in the future. Functional
recovery after hip repair in elderly subjects is related to long-term mortality
and independence. One potential method to improve post-operative functional
recovery is to treat peri-operative anemia. There is no consistent evidence on
the relation of the post operative hemoglobin levels and functional outcome
after hip repair. Red blood cell transfusions are frequently necessary in the
usual post-operative care after hip surgery, because this type of surgery is
associated with considerable blood loss. Most hospitals in the Netherlands use
restrictive transfusion policy because of the potential risks associated with
allogenic red blood cell transfusions. This general accepted policy contrasts
with our clinical observation among 317 patients who underwent hip fracture
surgery and showed significantly longer hospital stay when having lower
post-operative hemoglobin values. With incidence rates of less than 0.1 % for
acute lung injury and of less than 0.01% for viral and bacterial infections,
the risks associated with red blood cell transfusions is relative low.
Study objective
To assess whether increasing low hemoglobin levels to near normal accelerate
functional recovery and shorten the revalidation period after hip fracture
surgery in the elderly.
Study design
This is a prospective randomized clinical trial.
The study will be performed in elderly patients undergoing hip surgery for
emergency reason. The patients must be at least 65 years. The transfusion
threshold group will consist of (minimal) 200 subjects and the restricted
transfusion group (= *usual care group*) will consist of (minimal) 200 patients
Intervention
In group A, the transfusion threshold group, the patients will receive as much
additional blood as needed to keep the hemoglobin level above 7.5 mmol/L (= 12
gr/dL). So women will be transfused till the normal hemoglobin level and in men
to near normal hemoglobin levels have been reached. Leukocyte depleted red
blood cell transfusion will be used.
Study burden and risks
No more risks are associated with participation than with usual patient care
after hip fracture surgery.
albinusdreef 2
2300RC Leiden
Nederland
albinusdreef 2
2300RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
age 65 years and older with hipfracture surgery
Exclusion criteria
multi trauma patient or hemorrhagic shock
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22437.058.08 |