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
  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:


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:
  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.
  Eligibility

Ages Eligible for Study:   18 Years and older
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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014