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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 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 200 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2015-04 |
| Est. Completion | 2025-03-20 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02410473
The ClinicalTrials.gov registry entry for NCT02410473 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Discarded blood samples is the first listed.
NCT02410473 reports 0 study locations.
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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