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Prospective Evaluation of Bleeding Risk of Anticoagulant and Anti-platelet Therapy

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.
 
ClinicalTrials.gov Identifier: NCT00625248
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah

Tracking Information
First Submitted Date February 19, 2008
First Posted Date February 28, 2008
Last Update Posted Date June 24, 2013
Study Start Date February 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 19, 2008)
To evaluate for differences between the patients undergoing interventional techniques with or without anticoagulant or antiplatelet therapy. [ Time Frame: 24 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 19, 2008)
To assess adverse events in all patients. [ Time Frame: 24 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Evaluation of Bleeding Risk of Anticoagulant and Anti-platelet Therapy
Official Title A Prospective Evaluation of Bleeding Risk of Anticoagulant and Antiplatelet Therapy for Interventional Techniques
Brief Summary This study will evaluate bleeding risk and differences in outcomes in patients receiving and not receiving anticoagulant or antiplatelet therapy
Detailed Description
  1. To evaluate bleeding risk in interventional procedures in patients with or without antiplatelet and/or anticoagulant therapy.
  2. To evaluate differences in outcomes in patients not receiving any anticoagulant or antiplatelet therapy compared to patients receiving various types of drugs with anticoagulant or antiplatelet therapeutic effects.
  3. To evaluate and compare the adverse event profiling all patients.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population ambulatory surgery center patients
Condition Bleeding
Intervention Drug: Antithrombotics
With or without or discontinuted use of Antithrombotics
Other Name: anticoagulant or antiplatelet drugs
Study Groups/Cohorts
  • no anthithrombotic
    procedures where there were no antithrombotics
    Intervention: Drug: Antithrombotics
  • Antithrombotic - continued
    patients who are on antithrombotics
    Intervention: Drug: Antithrombotics
  • Discontinued Antithrombotic
    Patients who were on antithrombotics but have been discontinued
    Intervention: Drug: Antithrombotics
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2013)
12000
Original Estimated Enrollment
 (submitted: February 19, 2008)
1000
Actual Study Completion Date January 2010
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects undergoing interventional techniques. Subjects who were able to give voluntary, written informed consent.

Exclusion Criteria:

  • All those things, patients on heparin, dextran, and low molecular heparin
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00625248
Other Study ID Numbers protocol 18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
Study Sponsor Pain Management Center of Paducah
Collaborators Not Provided
Investigators
Principal Investigator: Laxmaiah Manchikanti, MD Ambulatory Surgery Center, Paducah
PRS Account Pain Management Center of Paducah
Verification Date June 2013