Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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 limb salvage procedure that frequently requires perioperative or post-operative transfusions of blood products.

Primary Objective

• To evaluate the difference in intra-or post-operatively transfused blood volume (mL/kg) for patients undergoing limb salvage procedures of the distal femur or proximal tibia who are randomized to receive perioperative tranexamic acid (TXA) versus placebo.

Secondary Objectives

• To evaluate changes in platelets and in hemoglobin from pre-op to post-op level for patients randomized to receive perioperative TXA versus placebo.

• To evaluate differences in post-operative daily surgical drain output for patients randomized to receive perioperative TXA versus placebo.

• To evaluate changes in estimated blood loss (EBL) for patients randomized to receive perioperative TXA versus placebo.

• To evaluate the association between the intra-or post-operatively transfused blood volume and estimated blood loss (EBL) for patients randomized to receive perioperative TXA and placebo, respectively.

Exploratory Objectives

• To evaluate differences in functional outcomes post-operatively for patients randomized to receive perioperative TXA versus placebo.

• To explore if significant correlations are observed between parameters reported with rotational thromboelastometry (ROTEM®) and EBL and transfusion requirements in pediatric and young adult patients undergoing limb salvage procedure who are randomized to perioperative TXA versus placebo.

• To evaluate differences in the prevalence and management of wound complications such as superficial or periprosthetic infections, wound dehiscence, contact dermatitis, post- operative hematomas, or any other clinically significant wound complication between patients randomized to receive perioperative TXA versus placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• 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:

• Peripheral absolute neutrophil count (ANC) ≥ 1000/mm^3

• 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 Criteria:

• 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.