Antiplatelet Therapy Continuation in Spine Surgery - Its Effect on Postoperative Morbidity and Mortality
Recruitment status was Not yet recruiting
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.
Deep Vein Thrombosis
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Impact of Continued Use of Clopidogrel and / or Aspirin on Outcomes in Patients Undergoing Lumbar Spine Surgery. A Prospective Observational Study|
- Postoperative hemorrhagic, thrombotic, and neurological complications [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
- length of stay [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Low-risk patients, not on APAs
Patients not at risk of coronary and/or cerebrovascular disease, and not consuming APAs
High-risk patients, not on APAs
Patients at high risk for cardio/cerebrovascular disease (diabetes mellitus, cigarette smoking, hypercholesterolemia, hypertension, morbid obesity), but not taking APAs.
APA for primary prevention
High-risk patients with cardiovascular risk factors (as above), in whom APA is prescribed as primary prevention of coronary artery disease (CAD).
APA for secondary prevention
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01006083
|Contact: Zvi Lidar, MDfirstname.lastname@example.org|
|Contact: Halil Salame, MDemail@example.com|
|Tel Aviv Sourasky medical center||Not yet recruiting|
|Tel Aviv, Israel, 64239|
|Sub-Investigator: Yifat Klein, PhD|
|Sub-Investigator: Zvi Lidar, MD|
|Sub-Investigator: Gilad Regev, MD|
|Sub-Investigator: Halil Salame, MD|
|Sub-Investigator: Uri Kenan, MD|
|Principal Investigator:||Idit Matot, MD||Tel-Aviv Sourasky Medical Center|