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:
Participant gender:
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.