Expired Study
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Dallas, Texas 75390


Purpose:

We believe ongoing bleeding during complex cardiac surgery can be accurately measured and that administration of a specific blood product replacement strategy designed to optimally slow or stop the bleeding can be followed by the during the operation. Patients at risk of significant bleeding after complex cardiac surgery will be approached to allow their operation to be watched by study personnel to see if ongoing blood loss can be accurately measured and to see how quickly a prescribed, standardized blood product replacement protocol to control the bleeding does slow or stop the bleeding. Permission to review the medical record to see if bleeding risk features can be identified and permission to follow the patient after surgery to see how they recover is also requested.


Criteria:

Inclusion Criteria: Eligible male and female patients will include those who are over 18 kg (identified as the lower inclusion threshold so as to standardize CPB circuit dilution) and less than 75 years old (to limit excessive stroke risk) and at theoretically increased risk for excessive bleeding following cardiopulmonary bypass, including patients: 1. undergoing repeat sternotomy, or 2. undergoing combined procedures (i.e. - valve and coronary artery surgery), or 3. undergoing multiple valve surgery, or 4. undergoing aortic root replacement with/without deep hypothermic circulatory arrest, or 5. undergoing complex congenital cardiac surgery Exclusion Criteria: Ineligible patients include those: 1. with known coagulation factor deficiency, or 2. refusing to receive donor blood products if necessary, or 3. undergoing emergency surgery, or 4. undergoing their first coronary artery bypass surgery or their first valve repair/replacement, or 5. with history of previous stroke or other significant thromboembolic event within 6 months (such as pulmonary embolism, valve obstruction [if not replacing this valve in upcoming operation], renal vein thrombosis, acute MI, DVT ), or 6. with known thrombophilia, or 7. with active infection (bacteremia, sepsis, endocarditis, meningitis, urinary tract infection, cholecystitis, cellulitis, pneumonia) 8. pregnant, or 9. weight > 150 kg or < 18 kg


NCT ID:

NCT00672516


Primary Contact:

Study Chair
Marie E Steiner, MD, MS
University of Minnesota - Clinical and Translational Science Institute


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75390
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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