E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing surgery for the repair of fracture neck of femur that are on chronic oral warfarin sodium as anticoagulation prophylactics. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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)? |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
All cause morbidity during 0 – 30 days after surgery in Ocplex compared to plasma group. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
66 patients in a controll group, not randomised patients. |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Plasma and controll group |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |