View Clinical Trial (Medical Research Study)
RiaSTAP vs. Conventional Transfusion for Patients Undergoing Valve Replacement Surgery: RiaCT
| City: |
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Atlanta |
| State: |
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Georgia |
| Zip Code: |
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30322 |
| Conditions: |
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Heart Valve Disease With or Without Coronary Artery Disease |
| Purpose: |
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Heart surgery involving valve replacement often involves the use of the heart-lung machine
for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet
transfusion has been the primary therapy to treat bleeding after this type of procedure.
More recently, perioperative supplementation of purified fibrinogen (RiaSTAP, CSL Behring)
was shown to reduce bleeding and blood product use (plasma or platelets) after heart
surgery. The objective of this trial is to demonstrate the clinical equivalency and economic
utility of using fibrinogen concentrate, RiaSTAP for the mitigation of post-operative
bleeding in patients in lieu of platelet transfusion.
Purified fibrinogen concentrate has been approved by FDA, and it has been used for the
treatment of acute bleeding episodes in patients with low fibrinogen due to hereditary
causes (e.g., afibrinogenemia). Compared to the transfusion of platelets which may be
associated with volume overload, bacterial/viral infection, immunological effects and excess
blood clotting, purified fibrinogen has several advantages. First, it contains no liquid
plasma allowing for low volume infusion. Several viral inactivation/reduction steps are used
to prepare the fibrinogen concentrate, increasing its viral safety. No antibodies or white
blood cells are contained in the fibrinogen concentrate; therefore transfusion reactions are
rare. Although platelet transfusion is widely used after heart surgery, there has been no
randomized study to endorse this practice. In this study, patients undergoing heart valve
replacement will be randomized to receive either platelet (1 unit) transfusion or fibrinogen
concentrate (4g) after heparin anticoagulation is reversed. Subjects will be treated only if
there is evidence of significant microvascular bleeding. Fifteen minutes after the initial
treatment, subjects will be reevaluated for bleeding. If bleeding continues, subjects will
be treated with blood transfusion per institutional standard of care.
The primary endpoints for this study are the hemostatic condition of the surgical field and
24-hour total of blood product transfusion.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Willing and able to provide written informed consent
- Age >17 and < 86 years
- Patients undergoing planned cardiopulmonary bypass (CPB) for:
1. combined coronary artery bypass grafting and valve replacement/repair surgery
2. single valve replacement surgery
3. mitral valve repair surgery
3. or double valve surgery (aortic and mitral)
- Presence of clinically relevant microvascular bleeding after protamine administration
(hemostasis assessment score of 2-3)
- Patients should fulfill the following parameters prior to the study intervention:
- Body temperature > 35.0°C
- Blood pH > 7.2
- Hb > 7.0 mg/dL
- Activated clotting time (ACT) < 155 seconds
- CPB time > 60 minutes
Exclusion Criteria:
- Replacement of aorta
- Planned valve replacement without median sternotomy
- Previous valve replacement surgery (previous CABG acceptable)
- History or suspicion of a congenital or acquired coagulation disorder such as
hemophilia, von Willebrand disease, and liver disease
- Hemodialysis dependent renal failure
- Liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
increased ≥ 2-fold above the upper limit of local laboratory normal ranges)
- Known allergy/anaphylaxis to fibrinogen concentrate or apheresis platelet units
- Clopidogrel administration within 5 days of surgery
- Coumadin (warfarin) administration within 5 days of surgery
- Participation in another clinical study in the 4 weeks preceding surgery
- Any indication that a potential subject did not comprehend the study restrictions,
procedures, or consequences therein an informed consent cannot be convincingly given
- Life expectancy less than 48 hours
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| NCT ID: |
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NCT01283321 |
| Primary Contact: |
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Principal Investigator
Gautam Sreeram, MD
Emory University
Kathy F Egan, BSN, RN
Phone: 404-727-8463
Email: kfegan@emory.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Atlanta, Georgia 30322
United States
There is no listed contact information for this specific location.
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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