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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 because the information has not been verified recently.
Verified October 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01006083
First received: October 30, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Postoperative hemorrhagic, thrombotic, and neurological complications [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • length of stay [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

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)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients admitted for lumbar laminectomy, discectomy or foraminotomy.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006083

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

Locations
Israel
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
Investigators
Principal Investigator: Idit Matot, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

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
Study First Received: October 30, 2009
Last Updated: October 30, 2009
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Cerebral Infarction
Hemorrhage
Infarction
Myocardial Infarction
Pulmonary Embolism
Stroke
Thrombosis
Venous Thrombosis
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Embolism
Embolism and Thrombosis
Heart Diseases
Ischemia
Lung Diseases
Myocardial Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014