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Platelet Function Testing Help and Intraoperative Bleeding Risk for Patients Who Are on Plavix Prior to Surgery
This study is currently recruiting participants.
Verified by Cedars-Sinai Medical Center, April 2008
Sponsored by: Cedars-Sinai Medical Center
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00653900
  Purpose

A large number of patients are currently on Antiplatelet inhibition using aspirin or Plavix therapy (A Thieno pyridine - ADP mediated platelet inhibitor). A group of these patients often require Cardiac and/or Vascular surgical procedures. These patients are at a higher risk for perioperative bleeding complications and higher re-operation/re-exploration for bleeding and subsequent blood product transfusions.

The aim of this protocol is to assess platelet function via the "Verify Now" device prior to surgery. The Verify Now device requires a small drop of fresh blood for each sample and is an FDA approved device.

Our initial goal is to establish if a certain degree of platelet function abnormality can predict a higher bleeding complication or higher transfusions (Phase I, 20 patients). This initial study will allow us to determine a sample size for Phase II. Phase II will maintain the same protocol, however after completion of Phase I, a more accurate sample size determination can be made. Additionally, we want to establish if knowledge of platelet dysfunction will change procedure technique or preparation to lower bleeding and/or lead to cancellation/rescheduling of procedure (Phase III).

Participants will be those patients who are taking plavix and are undergoing vascular or cardiac surgery. They will undergo a platelet function evaluation measured as Platelet Response Unit (PRU) via the "verify now" device on admission/pre surgery. This test involves taking 1 drop of blood from the patient, one time, before the procedure. The Verify Now device is FDA approved.

Perioperative bleeding will be assessed by absolute drop in hematocrit immediate post-op compared to the immediate preoperative value. An additional discharge hematocrit will be used if no blood products have been used during the initial hospital stay. Hematocrit evaluation via a complete blood count is a part of standard patient care. Additionally, utilization of blood products (factors, PLT, PRBC's, etc.) will be assessed.

In order to conduct the research, patients will be identified by reviewing the OR schedule. All consecutive patients on ASA/Plavix will be mailed a letter in order to introduce them to the study. The letter provides a phone number to call if the patient does NOT want to receive a phone call from the investigative staff. This letter is uploaded under item 18-02 of the study application. If patients do not call the office, then the investigative staff will call the potential participants to introduce the study. Final consent will be completed in PACU on arrival at the hospital for planned surgical procedure.

A Hematocrit will be performed on the consented patient preoperatively, immediately post-op, and at discharge. A PRU will be assessed using a few drops of the patients' blood preoperatively (PACU). Patients' records will be reviewed to assess use of blood products. No additional follow up is required.

Patients' care will be no different than current standard of care, other than the 1 "verify now" test, which is done before the procedure.


Condition
Perioperative Bleeding

MedlinePlus related topics: Blood Transfusion and Donation
Drug Information available for: Clopidogrel Clopidogrel Bisulfate
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Does Platelet Function Testing Help us Assess Intraoperative Bleeding Risk in Cardiac and Vascular Surgery for Patients Who Are on Plavix Prior to Admission?

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Perioperative bleeding (absolute drop in hematocrit, utilization of blood products (factors, PLT, PRBC's, etc.) will be assessed. [ Time Frame: measured until discharge ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

1 drop of blood for the "verify now" test, which is done before the procedure.


Estimated Enrollment: 20
Study Start Date: April 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
All patients undergoing elective, invasive cardiac procedure on plavix prior to admission

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will be those patients who are taking plavix and are undergoing vascular or cardiac surgery.

Criteria

Inclusion Criteria:

  • All consenting participants who are taking plavix prior to undergoing vascular or cardiac surgery.

Exclusion Criteria:

  • All consenting participants who are NOT taking plavix prior to undergoing vascular or cardiac surgery.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653900

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Amanda B Lamer, PharmD     310-423-6403     lamerab@cshs.org    
Contact: Hai Tran, PharmD     310-423-5630     hai.tran@cshs.org    
Principal Investigator: Suhail Dohad, MD            
Sub-Investigator: Amanda B Lamer, PharmD            
Sub-Investigator: Hai Tran, PharmD            
Sub-Investigator: Sanjay Kaul, MD            
Sub-Investigator: Tracy Gerez            
Sub-Investigator: Stanley Chou, MD            
Sponsors and Collaborators
Cedars-Sinai Medical Center
  More Information

Responsible Party: CSMC ( Dr Suhail Dohad, PI )
Study ID Numbers: Pro00013820
Study First Received: April 2, 2008
Last Updated: April 2, 2008
ClinicalTrials.gov Identifier: NCT00653900  
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Verify now
platelet function
platelet function testing
bleeding risk
periprocedural bleeding
clopidogrel
Our initial goal is to establish if a certain degree of
platelet function abnormality can predict a higher bleeding
or higher transfusions.

Study placed in the following topic categories:
Clopidogrel
Blood Loss, Surgical
Intraoperative Complications
Hemorrhage
Congenital Abnormalities

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009