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NCT00156520 · ClinicalTrials.gov registry record · Phase 4
Platelet Function And Aggregometry In Patients With Aortic Valve Stenosis
A Phase 4 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT00156520 is a Phase 4 study that has completed, run by University of Rochester. The registered enrollment target is 40 participants.
The verdict
NCT00156520, a Phase 4 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
It is known that patients with aortic stenosis, including those undergoing cardiac surgery for this problem, are prone to developing bleeding problems, particularly of the gastrointestinal tract. It is believed that the shear stress associated with blood flow through the abnormal aortic valve results in abnormal hemostasis. Abnormalities include increased proteolysis of the von Willebrand factor (vWF) and increased binding of the high molecular weight multimers of vWF to platelet membranes with subsequent inappropriate platelet aggregation. Thus, appropriate aggregation of circulating platelets is impaired. Cardiac surgery is associated with significant alterations in hemostasis. Patients undergoing cardiac surgery consume a significant percent of available blood products throughout the United States and are subjected to various and numerous risks associated with blood product transfusion. In addition, excessive postoperative bleeding is a common cause for the need to surgically re-explore the chest cavity in patients who have just undergone cardiac surgical procedures. Such additional surgery carries further cost and risk. Following surgical correction of aortic valve stenotic pathology, associated vWF abnormalities appear to reverse. However, this process can take several days. Although all cardiac surgical patients are at risk for postoperative bleeding, patients undergoing aortic valve surgery for aortic stenosis may be particularly at risk for this postoperative complication. In addition, patients with aortic valve stenosis who undergo noncardiac surgery may have a predisposition to bleeding because of similar underlying shear stress induced abnormal vWF and platelet function. The proposed study is a trial to evaluate the effectiveness of 2 different antifibrinolytic drugs in ameliorating the hemostatic defect associated with aortic stenosis. Aprotonin, an antifibrinolytic agent which also has platelet preserving actions4, will be compared to the currently used
Interventions
- DRUG aprotonin; epsilon aminocaproic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-03 |
| Est. Completion | 2005-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00156520
The ClinicalTrials.gov registry entry for NCT00156520 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which aprotonin; epsilon aminocaproic acid is the first listed.
NCT00156520 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00156520 about?
NCT00156520 is a clinical study titled "Platelet Function And Aggregometry In Patients With Aortic Valve Stenosis". It is known that patients with aortic stenosis, including those undergoing cardiac surgery for this problem, are prone to developing bleeding problems, particularly of the gastrointestinal tract. It is believed that the shear stress associated with blood flow through the abnormal aortic valve result...
What is the current status of trial NCT00156520?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2005-03. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00156520?
The interventions under investigation include: aprotonin; epsilon aminocaproic acid (DRUG).
Who is sponsoring clinical trial NCT00156520?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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