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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625248
• Other study ID #: protocol 18
• Status: Completed
• Phase: N/A
• First received: February 19, 2008
• Last updated: June 20, 2013
• Start date: February 2008
• Est. completion date: January 2010

Study information

• Verified date: June 2013
• Source: Pain Management Center of Paducah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12000
• Est. completion date: January 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

Drug:
• Antithrombotics
With or without or discontinuted use of Antithrombotics

Locations

Country	Name	City	State
United States	Pain Management Center of Paducah	Paducah	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Pain Management Center of Paducah

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate for differences between the patients undergoing interventional techniques with or without anticoagulant or antiplatelet therapy.		24 months	No
Secondary	To assess adverse events in all patients.		24 months	No