An observational study in Aortic Coarctation, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged Up to 30 Days. Per ClinicalTrials.gov, last updated 2014-12-12.
Sponsored by Emory University · Observational
The primary goal of this investigation is to describe perioperative thrombin generation in neonates undergoing placement of a Blalock-Taussig (BT) shunt to better understand the coagulation changes that precipitate postoperative shunt occlusion.
To accomplish our goal, the investigators will measure preoperative levels of one major procoagulant (prothrombin) and one major anticoagulant (Antithrombin). The investigators will also measure preoperative and postoperative thrombelastograms (TEG) and preoperative and postoperative thrombin generation curves (TGC).
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 29 observational studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thrombin generation - peak amount
The thrombin generating capacity of plasma is measured using a fluorogenic substrate. Coagulation is initiated by contact activation and thrombin generation is monitored by a microplate fluorometer set that displays the progression of the fluorescence reaction. The peak amount of thrombin generated is expressed by absorbancy (nM).
Time frame: 2 years
Thrombin Generation Curve validation in neonates
The peak amount of thrombin generated as determined by the thrombin generation curve will be compared to the peak amount of thrombin generated as determined by the thromboelastogram. Both measure thrombin generation by absorbancy (nM).
Time frame: 2 years
The record gives a start of Jan 2010, a primary completion of Jan 2013 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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