Ewing Sarcoma of BonePhase 3NCT05024253
Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Will Change in Blood Loss and Transfusion Requirements.
A Phase 3 study testing Tranexamic acid injection and Saline in people with Ewing Sarcoma of Bone and Osteosarcoma, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Ewing Sarcoma of Bone, Osteosarcoma
- What is being tested?
- Tranexamic acid injection and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Aug 2021to 1 Feb 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Malignant bone tumor of the femur and finished neoadjuvant chemotherapy
- Candidate for resection and reconstruction by prosthesis. 3- Age 4-18 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ewing Sarcoma of Bone, Osteosarcoma
- Being tested
- Tranexamic acid injection, Saline
- Keywords
- tranexamic acid
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
Also called Cyklokapron®
. 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)
SalineOther
Also called Salt water
mixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl
| Study group | Role | What they receive |
|---|---|---|
| patient is receiving Tranexemic acid (TXA ) | Experimental | 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. Receives: Drug: Tranexamic acid injection |
| standard treatment (saline) | Placebo comparator | 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. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss will be changed by by Tranexamic acid when compared with saline or Not.
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.
Measured: during surgery
postoperative blood loss will be changed by Tranexamic acid when compared with saline or Not.
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.
Measured: after surgery , approximately 1-4 days
Secondary outcomes (1)
blood transfusion will be changed by Tranexamic acid when compared with saline or Not.
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
Measured: during surgery and approximately 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start2 Aug 2021
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ewing Sarcoma of BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M ELGHONEIMY, MD, Principal investigator, 57357 children cancer hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024253
- Sponsor's protocol ID
- CCHE-BoneT003
- Status last verified
- Oct 2022
- First submitted
- 17 Aug 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Levack AE, McLawhorn AS, Dodwell E, DelPizzo K, Nguyen J, Sink E. Intravenous tranexamic acid reduces blood loss and transfusion requirements after periacetabular osteotomy. Bone Joint J. 2020 Sep;102-B(9):1151-1157. doi: 10.1302/0301-620X.102B9.BJJ-2019-1777.R1.
PubMed 32862676Dadure C, Sauter M, Bringuier S, Bigorre M, Raux O, Rochette A, Canaud N, Capdevila X. Intraoperative tranexamic acid reduces blood transfusion in children undergoing craniosynostosis surgery: a randomized double-blind study. Anesthesiology. 2011 Apr;114(4):856-61. doi: 10.1097/ALN.0b013e318210f9e3.
PubMed 21358317Carabini LM, Moreland NC, Vealey RJ, Bebawy JF, Koski TR, Koht A, Gupta DK, Avram MJ; Northwestern High Risk Spine Group. A Randomized Controlled Trial of Low-Dose Tranexamic Acid versus Placebo to Reduce Red Blood Cell Transfusion During Complex Multilevel Spine Fusion Surgery. World Neurosurg. 2018 Feb;110:e572-e579. doi: 10.1016/j.wneu.2017.11.070. Epub 2017 Nov 22.
PubMed 29175569Johnson DJ, Johnson CC, Goobie SM, Nami N, Wetzler JA, Sponseller PD, Frank SM. High-dose Versus Low-dose Tranexamic Acid to Reduce Transfusion Requirements in Pediatric Scoliosis Surgery. J Pediatr Orthop. 2017 Dec;37(8):e552-e557. doi: 10.1097/BPO.0000000000000820.
PubMed 29120963
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Reduce Blood Loss and Transfusion Requirements? A Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05024253
- Acronym / sponsor ID
- CCHE-BoneT003
- Conditions
- Ewing Sarcoma of Bone, Osteosarcoma
- Keywords
- tranexamic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| patient is receiving Tranexemic acid (TXA ) | Experimental | Drug: Tranexamic acid injectionLoading 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. |
| standard treatment (saline) | Placebo comparator | Other: SalineLoading 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. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Malignant bone tumor of the femur and finished neoadjuvant chemotherapy
- Candidate for resection and reconstruction by prosthesis. 3- Age 4-18 years.
Key exclusion criteria (8 listed)
- Anatomic location other than femur de
- Reconstruction other than prosthesis
- Allergy to TXA
- Previous history of DVT
- Previous history of renal dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid injectionAlso: Cyklokapron®. 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) | Drug | patient is receiving Tranexemic acid (TXA ) |
| SalineAlso: Salt watermixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl | Other | standard treatment (saline) |
Primary outcome
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.
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.
1 secondary outcome
blood transfusion will be changed by Tranexamic acid when compared with saline or Not.
Time frame: during surgery and approximately 1-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 32862676Levack AE, McLawhorn AS, Dodwell E, DelPizzo K, Nguyen J, Sink E. Intravenous tranexamic acid reduces blood loss and transfusion requirements after periacetabular osteotomy. Bone Joint J. 2020 Sep;102-B(9):1151-1157. doi: 10.1302/0301-620X.102B9.BJJ-2019-1777.R1.
- Background: PubMed 21358317Dadure C, Sauter M, Bringuier S, Bigorre M, Raux O, Rochette A, Canaud N, Capdevila X. Intraoperative tranexamic acid reduces blood transfusion in children undergoing craniosynostosis surgery: a randomized double-blind study. Anesthesiology. 2011 Apr;114(4):856-61. doi: 10.1097/ALN.0b013e318210f9e3.
- Background: PubMed 29175569Carabini LM, Moreland NC, Vealey RJ, Bebawy JF, Koski TR, Koht A, Gupta DK, Avram MJ; Northwestern High Risk Spine Group. A Randomized Controlled Trial of Low-Dose Tranexamic Acid versus Placebo to Reduce Red Blood Cell Transfusion During Complex Multilevel Spine Fusion Surgery. World Neurosurg. 2018 Feb;110:e572-e579. doi: 10.1016/j.wneu.2017.11.070. Epub 2017 Nov 22.
- Background: PubMed 29120963Johnson DJ, Johnson CC, Goobie SM, Nami N, Wetzler JA, Sponseller PD, Frank SM. High-dose Versus Low-dose Tranexamic Acid to Reduce Transfusion Requirements in Pediatric Scoliosis Surgery. J Pediatr Orthop. 2017 Dec;37(8):e552-e557. doi: 10.1097/BPO.0000000000000820.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M ELGHONEIMY, MD principal investigator
57357 children cancer hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic acid injection and Saline in people with Ewing Sarcoma of Bone and Osteosarcoma, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss will be changed by by Tranexamic acid when compared with saline or Not. (time frame: during surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05024253, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.