HIT/TSA Phase III Study of Angiomax (Bivalirudin) in Patients With HIT/HITTS Type II Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)
Data Collection
Cardiovascular Diseases
Treatment Study
Summary
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.An open-label, prospective, multicenter, single-arm study; with a historical reference cohort of similarly identified HIT/HITTS patients from participating institutions that underwent cardiac surgery on CPB with alternative anticoagulation regimens during the period of approximately 12 months prior to initiation of the first patient into this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.125 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria * Provide written informed consent before initiation of any study-related procedures, and * Be at least 18 years of age, and * Be scheduled for CABG, CABG single valve surgery, or isolated single valve surgery on CPB. Patients undergoing repeat (redo) CABG are also considered eligible for this study, and demonstrated * New diagnosis or history of objectively documented HIT/HITTS Type II, defined as one or more of the following: 1. Positive heparin-induced platelet aggregation (HIPA) or other functional assay for HIT or immunoassay for HIT antibodies (ELISA), AND/OR 2. HIT: Thrombocytopenia associated with heparin therapy, where the platelet count has decreased by 50%\*, OR 3. HITTS: Thrombocytopenia (as defined in B above) PLUS any evidence of arterial or venous thrombosis Exclusion Criteria * Confirmed pregnancy at time of enrollment via IVRS (if woman of child-bearing potential) (Urine or serum pregnancy test) * Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit. * Intracranial neoplasm, arteriovenous malformation or aneurysm. * Dependency on renal dialysis or creatinine clearance \<30mL/min. * Ongoing treatment with warfarin (or other oral anticoagulant) at the time of enrollment. Patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline INR is \< 1.3 times control in the absence of heparin therapy. * Known allergy to Angiomax or hirudin derived drugs, or known sensitivity to any component of the product. * Patients receiving clopidogrel (Plavix®) within the previous 5 days may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with recent clopidogrel administration. * Patients receiving a glycoprotein IIb/IIIa inhibitor within the previous 48 hours prior to enrollment if abciximab (ReoPro®) or 12 hours if eptifibatide (Integrilin®) or tirofiban (Aggrastat®), may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with not waiting the 48 or 12 hour time period prior to enrollment. * Patients receiving lepirudin (Refludan®) or argatroban within the previous 24 hours prior to enrollment. Patients currently receiving lepirudin or argatroban can be enrolled if they are switched to Angiomax at least 24 hours prior to the planned cardiac surgery. * Patients receiving LMWH or thrombolytics within the previous 12 hours may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with not waiting the 12 hour time period. * Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment. * Refusal to undergo blood transfusion should it become necessary. * Any other disease or condition, which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial. * Planned surgical procedure in which proximal anastomoses will precede distal anastomoses of the bypass grafts. * Planned (\>1) double (or greater) valve repair-replacement (e.g.: AVR-MVR) surgery.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location