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

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ClinicalTrials.gov Identifier: NCT05024253
Recruitment Status : Recruiting
First Posted : August 27, 2021
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Children's Cancer Hospital Egypt 57357

Brief 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.

Condition or disease Intervention/treatment Phase
Ewing Sarcoma of Bone Osteosarcoma Drug: Tranexamic acid injection Other: Saline Phase 3

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 A third agent, aprotinin, was withdrawn from the market in 2007 owing to safety concerns noted in several studies, suggesting an increased risk of death and renal dysfunction in patients undergoing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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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)
Masking Description: The PI, primary surgeon, anesthesiologist, patient, all assisting surgeons and anesthesiologist as well operating and circulating nurse will be blinded to the study arm to which patient belongs to. Only clinical trial unit and pharmacist will be unblinded.
Primary Purpose: Treatment
Official Title: Does Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Reduce Blood Loss and Transfusion Requirements? A Double-blinded Randomized Controlled Trial
Actual Study Start Date : August 2, 2021
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : December 31, 2024


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 Name: 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 Name: Salt water




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05024253


Contacts
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Contact: dina m elgalaly, Bph 25351500 ext 7209 dina.elgalaly@57357.org

Locations
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Egypt
Children's Cancer Hospital Egypt 57357 Cairo, Egypt Recruiting
Cairo, Egypt
Contact: dina m elgalaly, bph    25351500 ext 7209    dina.elgalaly@57357.org   
Principal Investigator: ahmed elghoniemy, MD         
Sponsors and Collaborators
Children's Cancer Hospital Egypt 57357
Investigators
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Principal Investigator: Ahmed M ELGHONEIMY, MD 57357 children cancer hospital
Publications:
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Responsible Party: Children's Cancer Hospital Egypt 57357
ClinicalTrials.gov Identifier: NCT05024253    
Other Study ID Numbers: CCHE-BoneT003
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: August 2021

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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
Keywords provided by Children's Cancer Hospital Egypt 57357:
tranexamic acid
Additional relevant MeSH terms:
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Osteosarcoma
Sarcoma, Ewing
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants