Impact of Continued Use of Clopidogrel and / or Aspirin on Outcomes in Patients Undergoing Lumbar Spine Surgery. A Prospective Observational Study
Sponsor study identifier
observational
200
1 country
1
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The objective of this study is to evaluate the safety of antiplatelet (APA)therapy continuation in patients undergoing lumbar spine surgery (laminectomy, discectomy and foraminotomy), and to gather evidence-based data regarding postoperative outcomes potentially related to APA management.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2009
Actual (reported)November 2, 2009
Actual (reported)January 2010
Date type not reportedThis date has not been verified as actual or estimated.
January 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Postoperative hemorrhagic, thrombotic, and neurological complications
60 days
length of stay
30 days
Patients not at risk of coronary and/or cerebrovascular disease, and not consuming APAs
Patients at high risk for cardio/cerebrovascular disease (diabetes mellitus, cigarette smoking, hypercholesterolemia, hypertension, morbid obesity), but not taking APAs.
High-risk patients with cardiovascular risk factors (as above), in whom APA is prescribed as primary prevention of coronary artery disease (CAD).
Patients with a history of a coronary syndrome (stable/unstable angina); MI; transient ischemic attack (TIA)/stroke; severe carotid artery stenosis/stenting; or peripheral vascular disease, on APAs for secondary prevention.
Patients admitted for lumbar laminectomy, discectomy or foraminotomy.
Tel Aviv Sourasky medical center
Tel Aviv, 64239, Israel
Idit Matot, MD
Tel-Aviv Sourasky Medical Center
First Submitted
October 30, 2009
First Posted
November 2, 2009
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2012
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 2, 2009
Record last verified: 2009-10
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Source: ClinicalTrials.gov.
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