Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint… (NCT01422304) | Clinical Trial Compass
CompletedPhase 3
Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
1,198 participantsStarted 2011-10-12
Plain-language summary
This study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on coagulation parameters in participants undergoing hip fracture surgery or joint (hip/knee) replacement surgery with neuromuscular blockage induced by rocuronium or vecuronium.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Must be American Society of Anesthesiologists (ASA) Class 1, 2, or 3
* Must be scheduled for a hip fracture surgery or joint (hip or knee) replacement surgery under general anesthesia including the use of rocuronium or vecuronium for neuromuscular blockade
* Must be:
* Currently receiving thromboprophylactic (anti-clotting) therapy with low molecular weight heparin (LMWH) or unfractionated heparin (UFH), or
* Planned to initiate thromboprophylactic therapy with LMWH or UFH prior to or during surgery, or
* Currently receiving ongoing thromboprophylactic therapy with a vitamin K antagonist that has been temporarily substituted with peri-operative LMWH or UFH, and/or
* Currently receiving ongoing thromboprophylactic therapy with low-dose aspirin or other antiplatelet therapy
* Platelet count above the lower limit of normal range
* Appropriate candidate for rapid reversal of neuromuscular blockade
* Sexually active females must agree to use a medically accepted method of contraception through seven days after receiving protocol-specified medication
Exclusion Criteria:
* Anatomical malformations that may lead to difficult intubation
* Neuromuscular disorder that may affect neuromuscular blockade
* History of a coagulation disorder, bleeding diathesis, systemic lupus erythematosus or antiphospholipid syndrome
* History or evidence of active abnormal bleeding or blood clotting within 30 days prior to screening
* Significant hepatic dysfunction
* Sev…
What they're measuring
1
Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration
Timeframe: Up to 24 hours post study drug administration