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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: Completed study of Congenital Heart Disease and Rotational Thromboelastometry, sponsored by Boston Children's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
Interventions
- OTHER Intraoperative Blood Sample
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-03 |
What the finished NCT02352675 record still lists
NCT02352675 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02352675's enrollment target sits among peer trials
40 49th of 63 higher than 13 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease 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.
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