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NCT02352675 · ClinicalTrials.gov registry record

Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis

A clinical trial of Congenital Heart Disease and Rotational Thromboelastometry, sponsored by Boston Children's Hospital.

Completed
Registry status
40
Enrollment target
1
Study location

NCT02352675 is a study of Congenital Heart Disease and Rotational Thromboelastometry that has completed, run by Boston Children's Hospital. The registered enrollment target is 40 participants, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02352675, a study of Congenital Heart Disease and Rotational Thromboelastometry, has completed, sponsored by Boston Children's Hospital.

COMPLETED
Registry status
40 participants
Enrollment target
1
Study location

Study Summary

Lysine analogs, like tranexamic acid (TXA) or epsilon aminocaproic acid (EACA), are antifibrinolytic agents routinely administered in children undergoing different surgeries associated with a high bleeding risk (e.g. cardiac, craniofacial, and orthopedic surgeries). Although there is a growing literature regarding the pharmacokinetic characteristics of these drugs in children, the plasmatic concentration required to completely inhibit fibrinolysis remains to be determined. In this in vitro study, the investigators will use an experimental model of fibrinolysis designed for rotational thromboelastometry (ROTEM®) to determine the minimal concentration inhibiting fibrinolysis for both TXA and EACA. In addition, this study will be used to create and validate a new experimental assay to measure fibrinolysis and the effect of antifibrinolytic agents.

Interventions

  • OTHER Intraoperative Blood Sample

Study Locations (1)

Massachusetts

  • Boston Children's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2015-04
Est. Completion 2016-03

Sponsor

Boston Children's Hospital

462 total trials

What the Registry Record Tells You About NCT02352675

The ClinicalTrials.gov registry entry for NCT02352675 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (92% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Intraoperative Blood Sample is the first listed.

NCT02352675 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02352675 about?

NCT02352675 is a clinical study titled "Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis". Lysine analogs, like tranexamic acid (TXA) or epsilon aminocaproic acid (EACA), are antifibrinolytic agents routinely administered in children undergoing different surgeries associated with a high bleeding risk (e.g. cardiac, craniofacial, and orthopedic surgeries). Although there is a growing liter...

What is the current status of trial NCT02352675?

This trial is currently completed. The enrollment target is 40 participants. The study started on 2015-04. Estimated completion is 2016-03.

What conditions does trial NCT02352675 study?

This clinical trial studies the following conditions: Congenital Heart Disease, Rotational Thromboelastometry, Fibrinolysis.

What interventions are being tested in trial NCT02352675?

The interventions under investigation include: Intraoperative Blood Sample (OTHER).

Who is sponsoring clinical trial NCT02352675?

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

Where is trial NCT02352675 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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