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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Laxmaiah Manchikanti, MD, Pain Management Center of Paducah

ClinicalTrials.gov Identifier:

NCT00625248

First received: February 19, 2008

Last updated: June 20, 2013

Last verified: June 2013

History of Changes

Purpose

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

Condition	Intervention
Bleeding	Drug: Antithrombotics


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	A Prospective Evaluation of Bleeding Risk of Anticoagulant and Antiplatelet Therapy for Interventional Techniques

Resource links provided by NLM:

MedlinePlus related topics: Bleeding Blood Thinners

U.S. FDA Resources

Further study details as provided by Pain Management Center of Paducah:

Primary Outcome Measures:

To evaluate for differences between the patients undergoing interventional techniques with or without anticoagulant or antiplatelet therapy. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess adverse events in all patients. [ Time Frame: 24 months ] [ Designated as safety issue: No ]


Enrollment:	12000
Study Start Date:	February 2008
Study Completion Date:	January 2010
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Detailed Description:

To evaluate bleeding risk in interventional procedures in patients with or without antiplatelet and/or anticoagulant therapy.
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.
To evaluate and compare the adverse event profiling all patients.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

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: 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

More Information

Publications:

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
Study First Received:	February 19, 2008
Last Updated:	June 20, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Hemorrhage Pathologic Processes Anticoagulants

ClinicalTrials.gov processed this record on September 26, 2016

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