Patients undergoing surgery for the repair of fracture neck of femur that are on chronic oral warfarin sodium as anticoagulation prophylactics.
Conditions
Interventions
Trade Name: Ocplex
Pharmaceutical Form: Powder and solvent for solution for injection
Other descriptive name: Human coagulation factor II
Concentration unit: IU international unit(s)
Concentration nu
Sponsors
Örebro University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether reversal of warfarin sodium effect with plasma or Ocplex® can reduce perioperative morbidity during the first 30 postoperative days following surgery for fracture neck of femur in elderly patients. Is it possible that patients reversed with Ocplex® are ready for discharge home earlier than those given plasma (length of hospital stay)? ;Secondary Objective: To assess whether time to operation following decision for surgery, perioperative bleeding and mortality after 30 days, 6 months and 1 year are affected when warfarin sodium effect is reversed using plasma or Ocplex®. A final aim of the study will be to assess the costs of these alternative strategies in relation to the benefits obtained by rapid reversal of anticoagulation.;Primary end point(s): All cause morbidity during 0 – 30 days after surgery in Ocplex compared to plasma group. | — |
Countries
Sweden
Outcome results
None listed