Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany

Novo Nordisk A/S64 enrolled

Overview

This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Congenital Bleeding Disorder Congenital FVII Deficiency Glanzmann's Disease Acquired Bleeding Disorder Acquired Haemophilia

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent obtained from patient or patient's legally acceptable representative in which he agrees that the patient's pseudonymised personal data will be transferred for use in a scientific evaluation and publication Exclusion Criteria: * Due to the non-interventional observational character of the study, there are no exclusion criteria.

Outcomes

Primary Outcomes

Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved

Time frame: within 9 hours after initiation of treatment with NovoSeven® or of invasive procedures for which haemostasis will be maintained during the time period of haemostatic coverage with NovoSeven®

Secondary Outcomes

Time proportion of acute bleeding treatments resulting in effective pain relief

Time frame: within 9 hours after initiation of treatment with NovoSeven®

Proportion of patients experiencing one or more re-bleeds

Time frame: within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding)