NCT04410042

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

Tranexamic Acid (TXA) to Reduce Volume Of Blood Transfused In Pediatric And Young Adult Cancer Patients Undergoing Limb Salvage Procedure Of A Lower Extremity

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 24 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Cancer of the Bone
• Limb Salvage

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Given IV
OTHER	0.9% sodium chloride	Given IV

Timeline

• Start date: 2021-01-29
• Primary completion: 2024-01-16
• Completion: 2024-01-16
• First posted: 2020-06-01
• Last updated: 2024-12-20
• Results posted: 2024-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study