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

NCT01813058 is a Phase 1 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Perioperative blood loss (during operation and for entire hospital admission)

Interventions

  • DRUG Placebo
  • DRUG Tranexamic Acid

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2013-01
Est. Completion 2016-05
Phase Phase 1
Boston Children's Hospital

462 total trials

What the finished NCT01813058 record still lists

NCT01813058 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).

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

NCT01813058 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01813058's enrollment target sits among peer trials

120 479th of 2000 higher than 1,503 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01813058, the US trial registry maintained by the National Library of Medicine. NCT01813058 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.