Clinical trial
Does Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Reduce Blood Loss and Transfusion Requirements? A Double-blinded Randomized Controlled Trial
Name
CCHE-BoneT003
Description
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.
Trial arms
Trial start
2021-08-02
Estimated PCD
2024-02-01
Trial end
2024-02-01
Status
Completed
Phase
Early phase I
Treatment
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)
Arms:
patient is receiving Tranexemic acid (TXA )
Other names:
Cyklokapron®
Saline
mixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl
Arms:
standard treatment (saline)
Other names:
Salt water
Size
48
Primary endpoint
Intraoperative blood loss will be changed by by Tranexamic acid when compared with saline or Not.
during surgery
postoperative blood loss will be changed by Tranexamic acid when compared with saline or Not.
after surgery , approximately 1-4 days
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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:\n\nArm A: patient is not receiving TXA but instead receiving a placebo (saline injection) Arm B: patient is receiving TXA which is colorless solution.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}
Updated at
2024-02-07
1 organization
1 product
2 indications
Organization
Children's Cancer Hospital Egypt 57357Product
Tranexamic acidIndication
Ewing sarcomaIndication
Osteosarcoma