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

NCT00625248 | Completed DMC

• 1 other identifier: protocol 18
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bleeding

Outcome Measures

Primary Outcomes (1)

• To evaluate for differences between the patients undergoing interventional techniques with or without anticoagulant or antiplatelet therapy.

  24 months

Secondary Outcomes (1)

• To assess adverse events in all patients.

  24 months

Study Arms (3)

no anthithrombotic

procedures where there were no antithrombotics

Drug: Antithrombotics

Antithrombotic - continued

patients who are on antithrombotics

Drug: Antithrombotics

Discontinued Antithrombotic

Patients who were on antithrombotics but have been discontinued

Drug: Antithrombotics

Interventions

Antithrombotics DRUG

With or without or discontinuted use of Antithrombotics

Also known as: anticoagulant or antiplatelet drugs

Antithrombotic - continued; Discontinued Antithrombotic; no anthithrombotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ambulatory surgery center patients

You may qualify if:

• Subjects undergoing interventional techniques. Subjects who were able to give voluntary, written informed consent.

You may not qualify if:

• All those things, patients on heparin, dextran, and low molecular heparin

Sponsors & Collaborators

• Pain Management Center of Paducah: lead

Study Sites (1)

Pain Management Center of Paducah

Paducah, Kentucky, 42003, United States

Location

Related Publications (2)

• 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.

  PMID: 21785475 RESULT

• 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.

  PMID: 21927046 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Anticoagulants; Platelet Aggregation Inhibitors

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Laxmaiah Manchikanti, MD

  Ambulatory Surgery Center, Paducah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2010
• Last Updated: June 24, 2013

Record last verified: 2013-06

Locations

US (1)