Platelet Function And Aggregometry In Patients With Aortic Valve Stenosis

NCT00156520 | Completed Phase 4

• 1 other identifier: 10504
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 anti-fibrinolytic, epsilon aminocaproic acid (EACA).

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (5)

• 1. the PFA-100, a platelet related hemostasis test which is a high shear system test of platelet function

  PFA-100, a platelet related hemostasis test

• 2. the von Willebrand antigen test, an immunoassay

  von Willebrand antigen test

• 3. factor VIII coagulant activity test.

  Factor VIII coagulant activity test

• 4. Ristocetin cofactor activity test.

• 5. thromboelastography (TEG), a point-of-care test of hemostatic function which includes a measure of platelet function.

Secondary Outcomes (1)

• thromboelastography

Interventions

aprotonin; epsilon aminocaproic acid DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Strong Memorial Hospital, University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Aminocaproic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminocaproates; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Peter L Bailey, MD'

  University of Rochester, Rochester, NY 14642

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: March 1, 2005
• Study Completion: September 1, 2005
• Last Updated: April 12, 2010

Record last verified: 2010-04

Locations

US (1)