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

Inclusion Criteria: * Patients \>12 years of age with severe or moderate hereditary FX deficiency. Severe is defined as \<1 IU/dL and moderate as 1 to 5 IU/dL (3) * Patients who have given written informed consent (for sites in the USA this will include the Health Insurance Portability and Accountability Act (HIPAA) authorization statement), OR, in the case of 12-18 year olds, written informed consent from the parents/ guardians and where appropriate assent from the child * Patients requiring major surgery. Major surgery is defined as procedures typically requiring: * full anesthesia or regional anesthesia, e.g. epidural or spinal and * involving the opening of major cavities such as thoracic, abdominal surgery; orthopedic surgery, and Caesarean section (C-section) and * requiring at least one overnight stay in hospital (16) 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.