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Clinical Trials/EUCTR2006-005206-31-SE
EUCTR2006-005206-31-SE
Active, not recruiting
Not Applicable

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 sitesDecember 12, 2006
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ConditionsPatients undergoing surgery for the repair of fracture neck of femur that are on chronic oral warfarin sodium as anticoagulation prophylactics.
DrugsOcplex

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients undergoing surgery for the repair of fracture neck of femur that are on chronic oral warfarin sodium as anticoagulation prophylactics.
Sponsor
Örebro University Hospital
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 12, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Örebro University Hospital

Eligibility 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

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.

Outcomes

Primary Outcomes

Not specified

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