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

A Prospective Evaluation of Bleeding Risk of Anticoagulant and Antiplatelet Therapy for Interventional Techniques

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

Study Overview

• Status: Completed
• Conditions: Bleeding
• Intervention / Treatment: 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
• Enrollment (Actual): 12000

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Pain Management Center of Paducah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ambulatory surgery center patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
no anthithrombotic; procedures where there were no antithrombotics	Drug: Antithrombotics; With or without or discontinuted use of Antithrombotics; Other Names: anticoagulant or antiplatelet drugs
Antithrombotic - continued; patients who are on antithrombotics	Drug: Antithrombotics; With or without or discontinuted use of Antithrombotics; Other Names: 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 Names: anticoagulant or antiplatelet drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate for differences between the patients undergoing interventional techniques with or without anticoagulant or antiplatelet therapy.	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess adverse events in all patients.	24 months

Collaborators and Investigators

• Sponsor: Pain Management Center of Paducah

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): January 1, 2009
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: February 19, 2008
• First Submitted That Met QC Criteria: February 19, 2008
• First Posted (ESTIMATE): February 28, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 24, 2013
• Last Update Submitted That Met QC Criteria: June 20, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Anticoagulants; Platelet Aggregation Inhibitors
• Other Study ID Numbers: protocol 18