Efficacy of Tranexamic Acid for Reducing Blood Loss and Blood Transfusion After Periacetabular Osteotomy
Condition: Dysplasia, Congenital Hip
MeSH terms: Hip Dislocation, Congenital; Developmental Dysplasia of the Hip
Study type: Interventional

Summary: 
      The goal of this randomized controlled, double-blinded trial is to assess the efficacy of
      intravenous tranexamic acid, a drug, in reducing blood loss and transfusion in patients
      undergoing periacetabular osteotomy, an elective reorientation procedure for the hip joint.
      The investigators hypothesize that tranexamic acid will be more effective than placebo
      (normal saline solution) in reducing blood loss and transfusion after periacetabular
      osteotomy.
    

Detailed description: 
      Periacetabular osteotomy (PAO) is an elective reorientation surgery for the hip joint,
      typically for the treatment of hip dysplasia in young, otherwise healthy patients, which
      requires multiple pelvic osteotomies around the acetabulum. A major source of its
      perioperative morbidity is blood loss. The principal cause of postoperative blood loss after
      PAO is surgical trauma, with secondary activation of both the coagulation cascade and local
      fibrinolysis. In the PAO literature, allogeneic transfusion rates are as high as 58%, and
      blood loss can range to nearly 4 L. The risk of excessive blood loss and blood transfusion in
      young, healthy patients after elective surgery is an event that can be reduced with blood
      conservation protocols, which can include pharmacological agents. Tranexamic acid is a
      synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen
      activation that interferes with fibrinolysis. Multiple studies and meta-analyses have shown
      that intravenous administration of the antifibrinolytic agent tranexamic acid reduces
      postoperative bleeding and the need for transfusion during joint replacement surgery.
      However, no published data exists to support its use during PAO. We hypothesize that
      intravenous tranexamic acid will reduce perioperative blood loss and, thus, transfusion
      requirement in patients undergoing PAO. A total of 80 patients will be enrolled. Patients
      will be randomized to receive either intravenous tranexamic acid versus placebo (normal
      saline) during PAO. Calculated total blood loss (primary outcome) will be determined, and
      intraoperative cell saver utilization (secondary outcome), and (3) postoperative allogeneic
      blood transfusion (secondary outcome) will be recorded. Patients will be followed for a total
      of 6 weeks after surgical intervention. If the use of IV tranexamic acid in the PAO patient
      population significantly reduces total perioperative blood loss, then it would provide an
      efficacious and inexpensive method for reducing postoperative morbidity after PAO.
    

Intervention name(s): Tranexamic Acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Medication administered intra-operatively to promote blood clotting.; Saline solution
Other intervention name(s): TXA; Saline
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dysplasia, Congenital Hip; Osteotomy; Blood Transfusion; Tranexamic Acid