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Completed

NCT Number: NCT05024253

Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Will Change in Blood Loss and Transfusion Requirements.

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.

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Cancer Hospital Egypt 57357 Cairo, Egypt

Cairo, Egypt

About this study

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 A third agent, aprotinin, was withdrawn from the market in 2007 owing to safety concerns noted in several studies, suggesting an increased risk of death and renal dysfunction in patients undergoing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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Malignant bone tumor of the femur and finished neoadjuvant chemotherapy
  • Candidate for resection and reconstruction by prosthesis. 3- Age 4-18 years.

Exclusion criteria

  • Anatomic location other than femur de
  • Reconstruction other than prosthesis
  • Allergy to TXA
  • Previous history of DVT
  • Previous history of renal dysfunction
  • Congenital or acquired coagulopathy.
  • Congenital or acquired cardiomyopathy.
  • Previous history of convulsions.

Treatment and study plan

Tranexamic acid injection

Drug

. 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)

Other names: Cyklokapron®

Saline

Other

mixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl

Other names: Salt water

Primary outcomes

  1. Intraoperative blood loss will be changed by by Tranexamic acid when compared with saline or Not.

    Time frame: during surgery

    will be calculated based on measurement of number and weights of blood-soaked surgical swabs. As well as measurement of total volume of blood collected in suction container, after subtracting volume of saline used for washing wound.

  2. postoperative blood loss will be changed by Tranexamic acid when compared with saline or Not.

    Time frame: after surgery , approximately 1-4 days

    will be calculated based on measurement of number and weights of blood-soaked surgical swabs. As well as measurement of total volume of blood collected in suction container, after subtracting volume of saline used for washing wound.

Secondary outcomes

  1. blood transfusion will be changed by Tranexamic acid when compared with saline or Not.

    Time frame: during surgery and approximately 1-7 days

    Calculation of blood volume to be transfused (no of units in mls) = (Estimated blood volume ×(target HCT -actual HCT))/HCT of one unit of packed RBCs

Sponsors and collaborators

Lead sponsor

Children's Cancer Hospital Egypt 57357

Other

Registry information

Official study title

Does Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Reduce Blood Loss and Transfusion Requirements? A Double-blinded Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2021
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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