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

February 6, 2024 updated by: Children's Cancer Hospital Egypt 57357

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 A third agent, aprotinin, was withdrawn from the market in 2007 owing to safety concerns noted in several studies, suggesting an increased risk of death and renal dysfunction in patients undergoing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

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Children's Cancer Hospital Egypt 57357 Cairo, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Anatomic location other than femur de
  2. Reconstruction other than prosthesis
  3. Allergy to TXA
  4. Previous history of DVT
  5. Previous history of renal dysfunction
  6. Congenital or acquired coagulopathy.
  7. Congenital or acquired cardiomyopathy.
  8. Previous history of convulsions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient is receiving Tranexemic acid (TXA )

Loading dose: Prior to surgical incision, and according to allocated arm, pharmacist will prepare TXA injection at a dose of 10mg/kg diluted in 50ml normal saline (maximum concentration 100mg/ml).

Maintenance dose: Throughout surgery, continuous infusion at a dose of 5mg/kg/hour will be given until wound closure.
Drug: Tranexamic acid injection
. 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®
Placebo Comparator: standard treatment (saline)

Loading dose: Prior to surgical incision, and according to allocated arm, pharmacist will prepare 50 ml of 0.9% saline or TXA at a dose of 10mg/kg diluted in 50ml normal saline (maximum concentration 100mg/ml).

Maintenance dose: Throughout surgery, continuous infusion of saline will be given until wound closure.
Other: Saline
mixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl
Other Names:
  • Salt water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during surgery
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.
after surgery , approximately 1-4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during surgery and approximately 1-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer Hospital Egypt 57357

Investigators

  • Principal Investigator: Ahmed M ELGHONEIMY, MD, 57357 children cancer hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2021

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

August 22, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHE-BoneT003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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