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

Active, not recruiting

• Conditions: Patients undergoing surgery for the repair of fracture neck of femur that are on chronic oral warfarin sodium as anticoagulation prophylactics.

• Registration Number: EUCTR2006-005206-31-SE
• Lead Sponsor: Örebro University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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®. <br>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.