PPT Slide
Study Details
- Protect 1- Protect 2 Change: Oral heparin administered after recovery from residual anesthetic and pain medications instead of immediately following surgery in the post operative period
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- Clinicians to dose one of the two approved LMWHs in the U.S. (Aventis’ Lovenox or Pharmacia’s Fragmin)
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- Patients will be randomized to either 12 or 18 mls of oral heparin 3xs daily for 27 days or to injectable Lovenox, 2xs daily for 7 days
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- Double-blinded, double dummy
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- Expected enrollment = (to be determined with unblinding of data from PROTECT-1)
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- Like PROTECT-1, a multi-center study planned for sites in U.S., Russia, Poland, Spain and Ukraine
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- Using high enrolling sites from PROTECT-1
PROTECT-2 Phase III Study