An interventional study of Multiplate ADP® in Bleeding, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Diagnostic
The purpose of this study is to assess platelet aggregability by a "point of care" device (Multiplate®) to decrease the release time for coronary artery bypass graft (CABG ) in patients with acute coronary syndrome (ACS) in use of dual antiplatelet therapy.
This open, prospective, randomized study will be included patients with acute coronary syndrome (ACS) and coronary artery bypass graft (CABG) indication in use of double platelet aggregation (aspirin and inhibitor of ADP). The groups to be analyzed will be:
All patients included, after the explanations and signing the informed consent, will initially undergo preoperative examinations as institutional routine. In the immediate period (24 hours) after CABG will be collected on all results of tests to which the patient is submitted in accordance with the institutional routines, and the volume of chest tube bleeding and need for blood transfusions. Clinical data "MACE" will be collected throughout the patient's hospital stay.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 190 is close to the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hospitalization for ACS defined as:
the resting ECG compatible with ischemia or infarction in at least one of the criteria below:
Exclusion criteria:
Patients who will discontinue inhibitor-ADP for 5 days before surgery, and must be operated on the first working day after completing the 5 days without the drug. This group will have its aggregability evaluated by platelet function testing (Multiplate ADP®) immediately before the transport to the operating room.
Patients will be evaluated by platelet function testing (Multiplate ADP®) daily until the value obtained\> 46 AU, when they will be immediately released to CABG, to be held on the first working day after release.
Device: Multiplate ADP®
Patients will be evaluated by platelet function testing (Multiplate ADP®) daily until the value obtained\> 46 AU, when they will be immediately released to CABG
Bleeding by chest tubes in 24 hours postoperative.
Time frame: 24 hours postoperative.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital