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NCT04410042 · ClinicalTrials.gov registry record · Phase 3
Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure
A Phase 3 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
NCT04410042 is a Phase 3 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 15 participants.
The verdict
NCT04410042, a Phase 3 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
Study 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 place
Interventions
- DRUG Tranexamic Acid
- OTHER 0.9% sodium chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-01-29 |
| Est. Completion | 2024-01-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04410042
The ClinicalTrials.gov registry entry for NCT04410042 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tranexamic Acid is the first listed.
NCT04410042 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04410042 about?
NCT04410042 is a clinical study titled "Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure". 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...
What is the current status of trial NCT04410042?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2021-01-29. Estimated completion is 2024-01-16.
What interventions are being tested in trial NCT04410042?
The interventions under investigation include: Tranexamic Acid (DRUG), 0.9% sodium chloride (OTHER).
Who is sponsoring clinical trial NCT04410042?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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