Platelet Function Testing Help and Intraoperative Bleeding Risk for Patients Who Are on Plavix Prior to Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Cedars-Sinai Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00653900
First received: April 2, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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?

Resource links provided by NLM:


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

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
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: 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

No publications provided

Responsible Party: Dr Suhail Dohad, PI, CSMC
ClinicalTrials.gov Identifier: NCT00653900     History of Changes
Other Study ID Numbers: Pro00013820
Study First Received: April 2, 2008
Last Updated: April 2, 2008
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.

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications

ClinicalTrials.gov processed this record on September 18, 2014