We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Thromboelastography (TEG®) and Platelet Function in Patients on Anti-platelet Agents

This study has been terminated.
(Unable to get funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00901160
First Posted: May 13, 2009
Last Update Posted: April 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University Health Network, Toronto
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University
  Purpose
Can a post-operative analysis using a simple blood test (Thromboelastography(TEG®)) and Platelet Mapping Assay (PMA™) be able to detect the occurence of clotting or bleeding complications in patients on blood thinning (anti-platelet) agents?

Condition Intervention Phase
Blood Clotting Procedure: blood test Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study for the Prediction of Post-operative Thrombotic and Bleeding Complications in Non-cardiac Surgery Using Thromboelastography (TEG®) and Platelet Mapping Assay (PMA™) in Patients on Anti-platelet Agents

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Patients undergoing non-cardiac (non-ambulatory) surgery and are on anti-platelet agents, is hyper or hypocoagulability based on TEG® and PMA™ associated with increased risk of thrombotic and bleeding complications. [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Is hypercoagulability based on TEG®(MA) and PMA™ associated with increased risk of the following events post-op: MI, stroke, PE, DVT, death? [ Time Frame: 1 month ]
  • Is hypo-coagulation status associated with lower levels of nadir and discharge hemoglobin/hematocrit and increased transfusion? [ Time Frame: 1 month ]
  • Is coagulation status associated with hospital length of stay? [ Time Frame: 1 month ]

Enrollment: 200
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgical patients
Blood will be taken from patients who are on anti-platelet medication and are having surgery that requires an overnight stay. This is a pilot study to see if Thromboelastography® and Platelet Mapping Assay™ will be able to predict if a patient is at risk for a bleeding or a clotting problem after surgery.
Procedure: blood test
Blood will be taken from patients shortly after surgery in the recovery room in order to perform Thromboelastography® and Platelet Mapping Assay™ tests.

Detailed Description:
Two hundred patients coming for surgery who are taking anti-platelet medications will be enrolled in this study as a pilot, to determine the feasibility for a larger study. A simple blood test for clotting function will be done after surgery. Patients will be assessed daily during their hospital stay to determine if they have any clotting or bleeding complications. For analysis, groups will be divided into normal and increased or decreased ability to make a blood clot based on the TEG® and PMA™ test done. Complications will be recorded for each group and analyzed to determine if there is any difference between groups.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are having non-ambulatory, non-cardiac, elective surgery
Criteria

Inclusion Criteria:

  • patients on aspirin and/or clopidogrel for at least 10 days, having non-ambulatory, non-cardiac, elective surgery

Exclusion Criteria:

  • anemia (Hb < 100) or thrombocytopenia (platelet count < 80), having any known clotting abnormalities
  • family history of clotting abnormalities
  • concurrently on NSAIDs, warfarin therapy or other treatments affecting platelet function
  • renal impairment (Cr > 110 mg for females or Cr > 125 mg) or INR > 1.2
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901160


Locations
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
McMaster University
University Health Network, Toronto
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Summer Syed, M.D. Hamilton Health Sciences Corporation
  More Information

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT00901160     History of Changes
Other Study ID Numbers: 07-468
First Submitted: May 11, 2009
First Posted: May 13, 2009
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by McMaster University:
thromboelastography
post-operative complications
anti-platelet agents
prospective
pilot
patients taking anti-platelet agents

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors