Thrombin Generation in Neonates
Completed
Conditions studied: Blood Coagulation Disorders
In brief
Children having open heart surgery must be on a heart-lung bypass machine. It is essential that the blood in the heart-lung machine does not clot. This is accomplished by giving a drug called heparin, a "blood thinner". The process of making a clot involves a lot of steps. One of the steps involves a protein called thrombin. Heparin acts on thrombin to keep blood from clotting. A technique has been developed to measure the blood's ability to generate thrombin. The bloods's ability to generate thrombin is measured by a thrombin generation curve (TGC). This curve would be very helpful to know when choosing the dose of heparin. We haven't found any studies using TGC in babies less than a month old. We want to do a study comparing the TGC in 10 newborns without a heart defect to the TGC in 10 newborns with a congenital heart defect. To do this we will need one sample of blood. the sample we need is 3 cc which is a little more than 1/2 teaspoon. The blood sample for both groups is to be taken from the intravenous catheter (IV) the child will have placed for surgery. The newborns without a heart defect will be children having surgery for a non-cardiac problem.
Key facts
- Study ID
- NCT00165906
- Run by
- Emory University
- People needed
- 20
- Starts
- 2005-01-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2013-11-21
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing elective cardiac surgery scheduled at Children's Healthcare of Atlanta as a first time procedure OR patients undergoing elective non-cardiac surgery scheduled at Children's Healthcare of Atlanta (control group)
- Patients within the appropriate age group, i.e. less than 1 month old
- Parents or legal guardian willing for the child to participate and able to sign the provided informed consent -
You may not qualify if…
- Patients undergoing any emergent procedure/surgery
- Patients who are being administered preoperative anticoagulant therapy
- Patients with a known coagulation defect or coagulopathy
- Patients who are premature, i.e. less than 37 weeks gestational age
- Patient who are greater than 1 month of age
- Parents or legal guardian are unwilling or unable to sign the provided informed consent
- Patients who in the opinion of the investigators should not be included in the study
Where it is running
- Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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