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

STATUS

Recruiting
End date

Mar 13, 2025
participants needed

39
sponsor

St. Jude Children's Research Hospital

Updated on 13 June 2022

See if I qualify

cancer

absolute neutrophil count

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, postoperative hematomas, or any other clinically significant wound complication between patients randomized to receive perioperative TXA versus placebo.

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 given at the initiation of surgical preparation. The second dose will be given 6 hours after the first dose (either intraoperatively or post-operatively). All doses will be given intravenously. Doses will be double blinded and randomized for each surgical procedure.

Details

Condition	Cancer of the Bone, Limb Salvage
Treatment	0.9% sodium chloride, Tranexamic Acid
Clinical Study Identifier	NCT04410042
Sponsor	St. Jude Children's Research Hospital
Last Modified on	13 June 2022

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Eligibility		Yes	No	Not Sure
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

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