Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial
— ASACABGOfficial title:
Multiple Daily Doses Of Aspirin To Overcome Aspirin Hyporesponsiveness Post Cardiac Bypass Surgery
Verified date | March 2015 |
Source | Hamilton Health Sciences Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
Cardiac bypass surgery is an important treatment for patients with severely blocked arteries
(tubes that delivery oxygen and nutrients to the heart). Hundreds of thousands of these
operations are done each year to help relieve patients' chest pain and to prevent future
heart attacks. The surgery is done by "bypassing" blood flow around badly clogged arteries
by sewing on healthy vessels from another part of the body (usually from the leg or the
chest). Aspirin (a blood thinner) is given to patients once a day after their surgery
because it stops "sticky" cells in the blood (platelets) from blocking these new vessels
(which may lead to a future heart attack).
Research has shown that aspirin does not work as well in people after they have bypass
surgery as the investigators might expect (for reasons that are not fully understood). One
reason aspirin may not work as well after surgery is because the body makes many more
platelets after surgery than it would under normal circumstances. All of these new platelets
overwhelm the aspirin and continue to be "sticky" and ready to block off arteries. The
investigators believe that giving multiple daily doses of aspirin following bypass surgery
is more effective than giving aspirin once daily at blocking platelet activity.
Status | Completed |
Enrollment | 120 |
Est. completion date | August 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult subjects who undergo elective or urgent CABG surgery who are on or off aspirin during the preoperative period Exclusion Criteria: - (a) initial platelet count <100,000 (b) significant liver disease (c) renal impairment (CrCl<30 ml/min/1.73 m2) (d) receiving (or planned) clopidogrel therapy (e) receiving NSAIDs or other drugs that might interfere with aspirin's platelet-inhibitory effect (f) need for therapeutic doses of parenteral or oral anticoagulants after surgery and (g) off-pump CABG (h) clinically important bleeding (chest tube drainage >200ml/hr for 6hrs) |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton General Hospital | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum Thromboxane: Define an inadequate aspirin response as a value >0.69 ng/ml, which is 2 SD above the mean of aspirin-treated patients | Postoperative Day 4 | No | |
Secondary | Arachidonic Acid Induced Light Transmission Aggregometry (LTA): Aggregation will be expressed as the maximum percent change in light transmittance from baseline, with platelet-poor plasma used as a reference. | Postoperative Day 4 | No | |
Secondary | Arachidonic Acid Induced Multiple Electrode Platelet Aggregometry (MEA):Aggregation was recorded for 6 minutes and will be reported as the area under the curve (aggregation units x min). | Postoperative Day 4 | No | |
Secondary | DNA genetic analyses for single nucleotide polymorphisms | A single preoperative blood sample was drawn (on average of 1 week prior to surgery) | No |
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