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NCT02410473 · ClinicalTrials.gov registry record

Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery

A clinical trial, sponsored by Boston Children's Hospital.

Completed
Registry status
200
Enrollment target

NCT02410473: Completed study, sponsored by Boston Children's Hospital.

NCT02410473 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02410473 has completed, sponsored by Boston Children's Hospital.

COMPLETED
Registry status
200 participants
Enrollment target

Study Summary

Neonates, children with single ventricle congenital heart disease, and those undergoing multiple complex cardiac surgeries are at high risk of increased perioperative blood loss, and blood product transfusions. In addition, some of these patients will present an increased risk of postoperative thromboembolic complications. For a long time, bleeding management has been based on the empiric administration of different blood products (e.g. platelet concentrates, cryoprecipitates, and/or activated factor VII), topical hemostatic agents, and surgical manipulation. Recently, the use of viscoelastic tests (e.g. thromboelastography (TEG) or thromboelastometry (ROTEM)) increased, and allowed a better assessment of perioperative coagulopathy, and a more 'rational' treatment of bleeding. While TEG and ROTEM record the viscoelastic properties of whole blood by measuring mechanical impedance and related changes during clot formation, T2MR, a miniaturized, magnetic resonance-based diagnostic platform, measures how water molecules react in the presence of magnetic fields to evaluate a broad range of hemostasis measurements. In this study, we will prospectively collect demographic data, surgical characteristics, the amount of perioperative bleeding and blood product transfusion, results of laboratory assays, and postoperative outcomes (30-day follow-up or until discharge), with the aim to assess our current practice, and develop an algorithm-based approach for the administration of targeted blood product and pro-coagulant therapies. Our goals are: the reduction of blood product utilization, the reduction of the incidence of massive bleeding and postoperative thrombosis.

Interventions

  • OTHER Discarded blood samples
  • OTHER Discarded Urine Sample

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2015-04
Est. Completion 2025-03-20
Boston Children's Hospital

462 total trials

What the finished NCT02410473 record still lists

NCT02410473 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.

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

NCT02410473 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02410473 about?

NCT02410473 is a clinical study titled "Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery". Neonates, children with single ventricle congenital heart disease, and those undergoing multiple complex cardiac surgeries are at high risk of increased perioperative blood loss, and blood product transfusions. In addition, some of these patients will present an increased risk of postoperative throm...

What is the current status of trial NCT02410473?

This trial is currently completed. The enrollment target is 200 participants. The study started on 2015-04. Estimated completion is 2025-03-20.

What interventions are being tested in trial NCT02410473?

The interventions under investigation include: Discarded blood samples (OTHER), Discarded Urine Sample (OTHER).

Who is sponsoring clinical trial NCT02410473?

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

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Source: ClinicalTrials.gov NCT02410473, the US trial registry maintained by the National Library of Medicine. NCT02410473 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.