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

NCT00901160 | Terminated

• 1 other identifier: 07-468
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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?

Conditions

Blood Clotting

Keywords

thromboelastography; post-operative complications; anti-platelet agents; prospective; pilot; patients taking anti-platelet agents

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (3)

• Is hypercoagulability based on TEG®(MA) and PMA™ associated with increased risk of the following events post-op: MI, stroke, PE, DVT, death?

  1 month

• Is hypo-coagulation status associated with lower levels of nadir and discharge hemoglobin/hematocrit and increased transfusion?

  1 month

• Is coagulation status associated with hospital length of stay?

  1 month

Study Arms (1)

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

Interventions

blood test PROCEDURE

Blood will be taken from patients shortly after surgery in the recovery room in order to perform Thromboelastography® and Platelet Mapping Assay™ tests.

Surgical patients

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are having non-ambulatory, non-cardiac, elective surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• University Health Network, Toronto: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (2)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Summer Syed, M.D.

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2011
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

CA (2)