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

This study has been terminated.
(Unable to get funding)
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00901160
First received: May 11, 2009
Last updated: October 28, 2010
Last verified: May 2009
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Is hypo-coagulation status associated with lower levels of nadir and discharge hemoglobin/hematocrit and increased transfusion? [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Is coagulation status associated with hospital length of stay? [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: June 2011
Estimated 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

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
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
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: NCT00901160

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

No publications provided

Responsible Party: Dr. Summer Syed, M.D., Hamilton Health Sciences/McMaster University
ClinicalTrials.gov Identifier: NCT00901160     History of Changes
Other Study ID Numbers: 07-468
Study First Received: May 11, 2009
Last Updated: October 28, 2010
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014