Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery

Exclusion Criteria

• •Patients known to be pregnant, unless the surgery is C-section.
• •Patients who participated in a clinical study trial in the last 30 days prior to study enrolment, except if they have been involved in another study involving Coagadex.
• •Patients with a known history of inhibitor development to FX.
• •Patients who are required or expected to take other factor X-containing medications during or after surgery.
• •Patients with existing known thrombocytopenia (platelets \< 50 x 109/L).
• •Patients with existing known clinically significant renal disease (creatinine \>200 µmol/L).
• •Patients with existing known clinically significant liver disease (ALT levels greater than three times the upper limit of normal).
• •Patients with existing known other coagulopathy or thrombophilia.
• •Patients with a known intolerance or allergy to Coagadex or its excipients.
• •Patients known to have abused chemicals or drugs within the past 12 months.
• •Patients with a history of unreliability or non-cooperation.