Anemia Clinical Trial
Official title:
Effect of Tranexamic Acid on Blood Loss and Transfusion Need in Patients Operated With a Short Intramedullary Nail, for Pertrochanteric Fractures .
The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with
pertrochanteric hip fractures.
Tranexamic acid is a well known drug used in many types of surgery. The investigators wish
to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood
loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric
hip fracture.
An interim analysis was planned when reaching 60 inclusions. The interim analysis was
conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was
considered a reason to halt the study. The 0.001 level was chosen as a simple approach to
this interim analysis from the Haybittle-Peto boundary
Studies have shown that hip fractures have a hidden blood loss besides the recorded
perioperative blood loss. Patients who are osteosynthesised with an intramedullary nail have
been shown to have the largest hidden blood loss.
Postoperative anaemia is associated with a higher morbidity and mortality. We wish to
investigate the possibility of reducing this hidden blood loss, with the use of a well known
drug (tranexamic acid) that is widely used to reduce blood loss in other forms of surgery
and in multitraumatized patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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