View Clinical Trial (Medical Research Study)
Management of Excessive Bleeding Following Cardiopulmonary Bypass: A Pilot Feasibility Study
| City: |
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Dallas |
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Texas |
| Zip Code: |
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75390 |
| Conditions: |
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Hemorrhage - Cardiopulmonary Bypass |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT00672516 |
| Primary Contact: |
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Study Chair
Marie E Steiner, MD, MS
University of Minnesota - Clinical and Translational Science Institute
Marie E Steiner, MD, MS
Phone: 612-626-2778
Email: stein083@umn.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Dallas, Texas 75390
United States
Philip E Greilich, MD
Phone: 214-645-8089
Email: Philip.Greilich@UTSouthwestern.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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