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NCT01813058 · ClinicalTrials.gov registry record · Phase 1

Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery?

A Phase 1 study, sponsored by Boston Children's Hospital.

Completed
Registry status
Phase 1
Development phase
120
Enrollment target

NCT01813058 is a Phase 1 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 120 participants.

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The verdict

NCT01813058, a Phase 1 study, has completed, sponsored by Boston Children's Hospital.

COMPLETED
Registry status
Phase 1
Development phase
120 participants
Enrollment target

Study Summary

Adolescent idiopathic scoliosis surgery is an extensive procedure associated with significant blood loss frequently requiring the transfusion of blood. Tranexamic acid (TXA) is a synthetic antifibrinolytic (prevents breakdown of the blood clot) that has been used to extensively reduce transfusion in pediatric major surgery, including cardiac, craniofacial and orthopedic surgery. In this prospective randomized double-blinded study, the investigators wish to evaluate the hypothesis that TXA is more effective than standard of care at decreasing blood loss and blood transfusion perioperatively in children and adolescents undergoing idiopathic scoliosis surgery.

Interventions

  • DRUG Placebo
  • DRUG Tranexamic Acid

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2013-01
Est. Completion 2016-05
Phase Phase 1

Sponsor

Boston Children's Hospital

462 total trials

What the Registry Record Tells You About NCT01813058

The ClinicalTrials.gov registry entry for NCT01813058 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01813058 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01813058 about?

NCT01813058 is a clinical study titled "Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery?". Adolescent idiopathic scoliosis surgery is an extensive procedure associated with significant blood loss frequently requiring the transfusion of blood. Tranexamic acid (TXA) is a synthetic antifibrinolytic (prevents breakdown of the blood clot) that has been used to extensively reduce transfusion in...

What is the current status of trial NCT01813058?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2013-01. Estimated completion is 2016-05.

What interventions are being tested in trial NCT01813058?

The interventions under investigation include: Placebo (DRUG), Tranexamic Acid (DRUG).

Who is sponsoring clinical trial NCT01813058?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.