Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Will Change in Blood Loss and Transfusion Requirements.
Condition: Ewing Sarcoma of Bone; Osteosarcoma
MeSH terms: Osteosarcoma; Sarcoma, Ewing
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to investigate whether previously reported benefit of Tranexamic
      acid in pediatric orthopedic surgeries could be recapitulated in bone tumor surgeries or not
      through a double blinded randomized controlled trial done in children cancer hospital 57357.
    

Detailed description: 
      Resection of bone tumors is commonly associated with considerable intra and post-operative
      blood loss due to extensive soft tissue dissection, multiple bone osteotomies, prolonged
      operative time. The intraoperative use of limb tourniquet to reduce bleeding may not be
      applicable in all situations e.g. arm, thigh and pelvic surgeries. The use of cell savers for
      auto transplantation of blood is not preferred in cancer surgeries. Antifibrinolytic drug are
      currently used to reduce perioperative blood loss in a variety of orthopedic surgeries.
      Currently, the most common agents used are EACA and TXA. A third agent, aprotinin, was
      withdrawn from the market in 2007 owing to safety concerns noted in several studies,
      suggesting an increased risk of death and renal dysfunction in patients undergoing cardiac
      surgery. Slow to adopt in obstetric population, TXA became popular for patients with
      hereditary bleeding disorders for whom menorrhagia, frequent spontaneous nose bleeds, or
      dental procedures could be life threatening. With strong record as an effective and safe
      medicine, TXA has earned its place on the World Health Organization List of Essential
      Medicines as an important drug needed in every health system. More recently, its use has
      expanded to treat or prevent excessive blood loss from trauma and major surgery, including
      cardiac, orthopedic, and hepatic procedures. TXA, a lysine analogue, reversibly binds to the
      plasminogen lysine receptors and thereby blocks plasminogen from binding to fibrin (tPA can
      only activate fibrin-bound plasminogen and produce plasmin responsible for cleaving fibrin
      molecule and dissolving the blood clot) TXA has been extensively studied in joint replacement
      surgeries specifically total knee replacement, scoliosis surgery, and in trauma surgeries.
      The question of efficacy of TXA in these surgeries was addressed in multiple prospective
      randomized studies and subsequent meta-analysis. Main concern regarding increased risk of DVT
      was negated in several of these studies. The American Academy of Orthopedic Surgeons provides
      a strong recommendation for the use of any administration of TXA for joint arthroplasty and
      states that it does not seem to increase the risk of thromboembolic or myocardial
      complications. Junlong Zhong et al. in 2019 published a systematic review and meta-analyses
      on 2500 pediatric patients undergoing corrective surgery for idiopathic scoliosis. They
      concluded that TXA was effective in reducing surgical time, intraoperative blood loss and
      blood transfusion without increasing complications. Levack et al. Published in 2020 a
      randomized controlled trial on role of TXA in reducing blood loss and transfusion in
      pediatric patients undergoing a periacetabular osteotomy. They concluded that TXA reduced
      blood loss by 293ml and reduced frequency of allogenic transfusions by 73%.

      The purpose of this trial is to investigate whether previously reported benefit of Tranexamic
      acid in pediatric orthopedic surgeries could be recapitulated in bone tumor surgeries or not
      through a double blinded randomized controlled trial done in children cancer hospital 57357.
    

Intervention name(s): Tranexamic acid injection; Saline
Intervention type(s): Drug; Other
Intervention description(s): . TXA, a lysine analogue, reversibly binds to the plasminogen lysine receptors and thereby blocks plasminogen from binding to fibrin (tPA can only activate fibrin-bound plasminogen and produce plasmin responsible for cleaving fibrin molecule and dissolving the blood clot); mixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl
Other intervention name(s): Cyklokapron®; Salt water
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized, double-blinded clinical trial will be done on all included case. They will be divided into two groups based randomly using Block Stratified Randomized Software program, after obtaining informed consent from eligible patient or his caregiver into two Arms:
Arm A: patient is not receiving TXA but instead receiving a placebo (saline injection) Arm B: patient is receiving TXA which is colorless solution.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: tranexamic acid