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NCT02656472 · ClinicalTrials.gov registry record · Phase 4

A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery

A Phase 4 study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 4
Development phase
22
Enrollment target

NCT02656472: Completed Phase 4 study, sponsored by Wake Forest University Health Sciences.

NCT02656472 is a Phase 4 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02656472, a Phase 4 study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 4
Development phase
22 participants
Enrollment target

Study Summary

The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolytic drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing pediatric cardiac surgery.

Primary Outcome

Consented patients had research-related blood draws (0.3 ml) at three time points: pre-CPB, post-CBP following protamine administration and 24 hours post-CPB. Average of the values run in duplicate was used for calculations. For samples with values reported as out of range (due to level being below detection), the lowest detectable value was assigned for analysis.

Interventions

  • DRUG Tranexamic acid
  • DRUG Epsilon Aminocaproic Acid

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2016-02
Est. Completion 2017-04
Phase Phase 4
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT02656472 record still lists

NCT02656472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

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

NCT02656472 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02656472 about?

NCT02656472 is a clinical study titled "A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery". The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolytic drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing pediatric cardiac surgery.

What is the current status of trial NCT02656472?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2016-02. Estimated completion is 2017-04.

What interventions are being tested in trial NCT02656472?

The interventions under investigation include: Tranexamic acid (DRUG), Epsilon Aminocaproic Acid (DRUG).

Who is sponsoring clinical trial NCT02656472?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02656472's enrollment target sits among peer trials

22 1731st of 2000 higher than 259 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT02656472, the US trial registry maintained by the National Library of Medicine. NCT02656472 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.