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

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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

Brief Summary:
This study will evaluate bleeding risk and differences in outcomes in patients receiving and not receiving anticoagulant or antiplatelet therapy

Condition or disease Intervention/treatment
Bleeding Drug: Antithrombotics

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
Actual Enrollment : 12000 participants
Time Perspective: Prospective
Official Title: A Prospective Evaluation of Bleeding Risk of Anticoagulant and Antiplatelet Therapy for Interventional Techniques
Study Start Date : February 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
no anthithrombotic
procedures where there were no antithrombotics
Drug: Antithrombotics
With or without or discontinuted use of Antithrombotics
Other Name: anticoagulant or antiplatelet drugs
Antithrombotic - continued
patients who are on antithrombotics
Drug: Antithrombotics
With or without or discontinuted use of Antithrombotics
Other Name: anticoagulant or antiplatelet drugs
Discontinued Antithrombotic
Patients who were on antithrombotics but have been discontinued
Drug: Antithrombotics
With or without or discontinuted use of Antithrombotics
Other Name: anticoagulant or antiplatelet drugs



Primary Outcome Measures :
  1. To evaluate for differences between the patients undergoing interventional techniques with or without anticoagulant or antiplatelet therapy. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. To assess adverse events in all patients. [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ambulatory surgery center patients
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

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): NCT00625248


Locations
United States, Kentucky
Pain Management Center of Paducah
Paducah, Kentucky, United States, 42003
Sponsors and Collaborators
Pain Management Center of Paducah
Investigators
Principal Investigator: Laxmaiah Manchikanti, MD Ambulatory Surgery Center, Paducah

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00625248     History of Changes
Other Study ID Numbers: protocol 18
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Anticoagulants