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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Manchikanti L, Malla Y, Wargo BW, Cash KA, McManus CD, Damron KS, Jackson SD, Pampati V, Fellows B. A prospective evaluation of bleeding risk of interventional techniques in chronic pain. Pain Physician. 2011 Jul-Aug;14(4):317-29.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Manchikanti L, Malla Y, Wargo BW, Fellows B. Infection control practices (safe injection and medication vial utilization) for interventional techniques: are they based on relative risk management or evidence? Pain Physician. 2011 Sep-Oct;14(5):425-34.

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
Last Update Posted:	June 24, 2013
Last Verified:	June 2013

Additional relevant MeSH terms:

Hemorrhage; Pathologic Processes; Anticoagulants