Perioperative Morbidity in Elderly patients undergoing Surgery for Fracture Neck of Femur. The Effect of Plasma or Ocplex® for reversal of Warfarin anticoagulation.

Örebro University Hospital0 个研究点开始时间: 2006年12月12日最近更新: 2012年3月19日

适应症

试验速览

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•- Patients with fractured neck of femur judged to be medically operable.
•- Age > or = 65 years.
•- Taking warfarin anticoagulation due to atrial fibrillation, deep vein thrombosis or lung embolism, except for those patients who are in the control group.
•- Have signed and dated Informed Consent.
•- Willing and able to comply with the protocol for the duration of the trial.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Hypersensitive or allergic to the active substance or supporting substances in Ocplex®.
•- Known allergy to heparin or history of heparin induced thrombocytopenia.
•- Patients who are on warfarin sodium due to prosthetic valve surgery.
•- Patients with other coagulation abnormalities or bleeding diathesis that may affect perioperative bleeding e.g. hemophilia, thrombocytopenia etc.
•- Patients with dementia or other neuro-psychiatric condition, and judged by the investigator not to be able to comply with the protocol.
•- Participation in another clinical trial.
•- Patients who have been administered plasma within 48 hours.
•- Patients who have hade a recent history of lung embolism or myocardial infarction.

发起方

Örebro University Hospital