Perioperative Bleeding Clinical Trial
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?
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.
The investigators 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, the investigators 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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03505723 -
PeriOperative ISchemic Evaluation-3 Trial
|
Phase 3 | |
Completed |
NCT02546648 -
PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study
|
Phase 3 |