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Antiplatelet Therapy Continuation in Spine Surgery - Its Effect on Postoperative Morbidity and Mortality

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
ClinicalTrials.gov Identifier:
First Posted: November 2, 2009
Last Update Posted: November 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tel-Aviv Sourasky Medical Center
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.

Hemorrhage Cerebrovascular Accident Myocardial Infarction Pulmonary Embolism Deep Vein Thrombosis

Study Type: Observational
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

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Postoperative hemorrhagic, thrombotic, and neurological complications [ Time Frame: 60 days ]

Secondary Outcome Measures:
  • length of stay [ Time Frame: 30 days ]

Estimated Enrollment: 200
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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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted for lumbar laminectomy, discectomy or foraminotomy.

Inclusion Criteria:

  • Aged > 18 years old,
  • Undergoing elective or urgent spinal surgery,
  • Included are procedures aimed to decompress the spinal canal in the lumbar region due to a degenerative disease, i.e., laminectomy, discectomy and foraminotomies.

Exclusion Criteria:

  • Patients with an infectious disease, tumor resection, trauma cases, or
  • Patients requiring lumbar fixation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006083

Contact: Zvi Lidar, MD 97236974134 zvil@tasmc.health.gov.il
Contact: Halil Salame, MD 97236974134 salame@tasmc.health.gov.il

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         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Idit Matot, MD Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: Prof. Idit Matot, Department of Anesthesiology & Intensive Care, Tel Aviv Sourasky medical center
ClinicalTrials.gov Identifier: NCT01006083     History of Changes
Other Study ID Numbers: TASMC-09-IM-0540-CTIL
First Submitted: October 30, 2009
First Posted: November 2, 2009
Last Update Posted: November 2, 2009
Last Verified: October 2009

Keywords provided by Tel-Aviv Sourasky Medical Center:
antiplatelet therapy
ischemic events

Additional relevant MeSH terms:
Myocardial Infarction
Pulmonary Embolism
Venous Thrombosis
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents