Status:
TERMINATED
Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Cancer of the Bone
Limb Salvage
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE3
Brief Summary
This is a randomized double-blind control trial evaluating the use Tranexamic acid (TXA) to decrease blood loss and transfusion requirements in pediatric and young adult cancer patients undergoing a l...
Detailed Description
Eligible participants undergoing limb salvage procedures will be randomized to receive either tranexamic acid (TXA) or placebo peri-operatively. The initial dose of tranexamic acid/placebo will be gi...
Eligibility Criteria
Inclusion
- Participant undergoing limb salvage procedure of malignant bone tumor of the distal femur or proximal tibia, which typically requires blood transfusions.
- Patient under the age of 25
- Adequate bone marrow function defined as:
- Upward trending peripheral absolute neutrophil count (ANC)
- Platelet count ≥ 100,000/mm\^3 (transfusion independent defined as no platelets required for 4 days)
- Hemoglobin ≥ 8.0 g/dL
- No RBC transfusion within 24 hours
- Adequate renal function defined as:
- Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73m\^2 OR
- Maximum serum creatinine based on age/gender as follows: Age 1 day to \< 1 years: maximum serum creatinine (mg/dL) 0.6 for males and 0.5 for females; Age 1 to \< 2 years: maximum serum creatinine (mg/dL) 0.6 for males and 0.6 for females; Age 2 to \< 6 years: maximum serum creatinine (mg/dL) 0.8 for males and 0.8 for females; Age 6 to \< 10 years: maximum serum creatinine (mg/dL) 1.0 for males and 1.0 for females; Age 10 to \< 13 years: maximum serum creatinine (mg/dL) 1.2 for males and 1.2 for females; Age 13 to \< 16 years: maximum serum creatinine (mg/dL) 1.5 for males and 1.4 for females; Age ≥ 16 years: maximum serum creatinine (mg/dL) 1.7 for males and 1.4 for females
- Adequate liver function defined as:
- Total bilirubin ≤ 1.5x the institutional upper limit of normal (IULN) for age
- ALT (SGPT) and AST (SGOT) ≤ 2.5x IULN for age (or \<5x IULN for patients with documented disease involving the liver or 10x IULN for patients receiving HDMTX)
- Serum albumin \> 2 g/dL
- Adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5
- Female participants of child-bearing potential (\>10 years old) must have a negative serum or urine pregnancy test within 72 hours of sedation
Exclusion
- Participants whose limb salvage procedure may require significant manipulation of major blood vessels.
- Participants with known bone marrow deficiency resulting in red blood cell deficiency (e.g. Diamond-Blackfan anemia)
- Participants receiving erythropoietin-stimulating agents (e.g. epoetin alfa)
- Participants with active hemorrhagic cystitis (e.g. alkylator-induced) with gross hematuria or \>50 RBCs per high powered field on urinalysis
- Participants actively receiving all-trans retinoic acid (ATRA) or isotretinoin (Accutane)
- Participants with known allergies to antifibrinolytics
- Participants with known hypercoagulopathies
- Personal history of a thrombosis or active thrombus
- Participants currently on anticoagulation medications (e.g. warfarin, enoxaparin)
- Participants with a history of seizures. Patients with a history of febrile seizure are eligible.
- Persisting toxicity related to other systemic therapies (e.g. chemotherapy) which constitutes an unacceptable safety risk based on the judgment of the PI and/or the primary treating physician.
- Female participants who are currently pregnant or actively breastfeeding.
- Female participants who are currently receiving estrogen-based contraception therapy.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
- Participants enrolled in another clinical trial utilizing an IND/IDE experimental therapy.
- Participants with a history of CNS disease.
- Participants with known bleeding disorder.
- Participants with known platelet dysfunction.
Key Trial Info
Start Date :
January 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04410042
Start Date
January 29 2021
End Date
January 16 2024
Last Update
December 20 2024
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105