Prospective Evaluation of Bleeding Risk of Anticoagulant and Anti-platelet Therapy - Full Text View

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: Anticoagulant and Antiplatelet Therapy

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: Blood Thinners

Drug Information available for: Aspirin

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 ]

Estimated Enrollment:	1000
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
I Control group	Drug: Anticoagulant and Antiplatelet Therapy NSAIDs, low dose aspirin, high dose aspirin, antiplatelet, herbal medications, Coumadin, combinations
II A) Patients on nonsteroidal anti-inflammatory agents B) Patients who have stopped taking nonsteroidal anti-inflammatory agents prior to interventional techniques for 3 days or longer	Drug: Anticoagulant and Antiplatelet Therapy NSAIDs, low dose aspirin, high dose aspirin, antiplatelet, herbal medications, Coumadin, combinations
III A) Low dose aspirin therapy of 81 mg B) Patients who have stopped taking low dose aspirin therapy of 81 mg, at least 7 days or longer	Drug: Anticoagulant and Antiplatelet Therapy NSAIDs, low dose aspirin, high dose aspirin, antiplatelet, herbal medications, Coumadin, combinations
IV A) High dose aspirin therapy - more than 81 mg - generally 325 mg B) Patients who have stopped taking high dose aspirin therapy at least 7 days	Drug: Anticoagulant and Antiplatelet Therapy NSAIDs, low dose aspirin, high dose aspirin, antiplatelet, herbal medications, Coumadin, combinations
V A) Antiplatelet therapy: Aspirin Plavix (Clopidogrel) Ticlopidine (Ticlid) Clopidogrel (Plavix) Cilostazol (Pletal) Aspirin plus dipyridamole (Asasantine Retard) Tirofiban (Aggrastat) Abciximab (ReoPro) Eptifibatide (Integrilin) Defibrotide Dipyridamole (Persantine) B) Patients who have stopped taking antiplatelet therapy- 7 to 14 days	Drug: Anticoagulant and Antiplatelet Therapy NSAIDs, low dose aspirin, high dose aspirin, antiplatelet, herbal medications, Coumadin, combinations
VI A) Patients on herbal medications (garlique, ginkgo, ginseng, etc.) B) Patients who have stopped taking herbal medications, such as garlic (Garlique, ginkgo, ginseng, etc.)	Drug: Anticoagulant and Antiplatelet Therapy NSAIDs, low dose aspirin, high dose aspirin, antiplatelet, herbal medications, Coumadin, combinations
VII A) Coumadin therapy - INR of less than 1.5 B) Coumadin therapy - INR of greater than 1.5	Drug: Anticoagulant and Antiplatelet Therapy NSAIDs, low dose aspirin, high dose aspirin, antiplatelet, herbal medications, Coumadin, combinations
VIII A) Combination of aspirin and nonsteroidal agents B) Patients who have stopped taking combination of aspirin and nonsteroidal agents	Drug: Anticoagulant and Antiplatelet Therapy NSAIDs, low dose aspirin, high dose aspirin, antiplatelet, herbal medications, Coumadin, combinations
IX A) Combination of antiplatelet therapy and aspirin B) Patients who have stopped taking antiplatelet therapy and aspirin	Drug: Anticoagulant and Antiplatelet Therapy NSAIDs, low dose aspirin, high dose aspirin, antiplatelet, herbal medications, Coumadin, combinations
X A) Combination of Coumadin, antiplatelet therapy, and/or aspirin B) Patients who have stopped taking combination	Drug: Anticoagulant and Antiplatelet Therapy NSAIDs, low dose aspirin, high dose aspirin, antiplatelet, herbal medications, Coumadin, combinations

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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625248

Sponsors and Collaborators

Pain Management Center of Paducah

Investigators

Principal Investigator:

Laxmaiah Manchikanti, MD

Ambulatory Surgery Center, Paducah

More Information

No publications provided by Pain Management Center of Paducah

Additional 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.

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.

Responsible Party:	Laxmaiah Manchikanti, MD/Medical Director, Pain Management Center of Paducah and Ambulatory Surgery Center
ClinicalTrials.gov Identifier:	NCT00625248 History of Changes
Other Study ID Numbers:	protocol 18
Study First Received:	February 19, 2008
Last Updated:	October 12, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Hemorrhage
Pathologic Processes
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticoagulants
Therapeutic Uses
Pharmacologic Actions

Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Hematologic Agents

ClinicalTrials.gov processed this record on May 23, 2013