Peri-Operative Eltrombopag or Immune Globulin for Patients with Immune Thrombocytopaenia (The Bridging ITP Trial): Methods and Rationale.

Abstract

BACKGROUND\n\u2003The Bridging ITP Trial is an open-label randomized trial designed to compare the oral thrombopoietin receptor agonist eltrombopag and intravenous immune globulin (IVIG) for patients with immune thrombocytopaenia (ITP) who require an increase in platelet count before elective surgery. Here, we report the study methods and rationale.\n\n\nMETHODS\n\u2003We designed a multi-centre, non-inferiority randomized trial comparing daily oral eltrombopag starting 3 weeks pre-operatively, and IVIG administered 1\u2009week pre-operatively for patients with ITP requiring a platelet count increase prior to surgery. Starting dose of eltrombopag is 50\u2009mg daily with a weekly pre-operative dose titration schedule, and treatment is continued for 1\u2009week after surgical haemostasis is achieved. IVIG is administered at a dose of 1 to 2 g/kg 1\u2009week pre-operatively with the allowance for a second dose within 1\u2009week after surgical haemostasis. The objective of the study is to demonstrate non-inferiority of eltrombopag for the primary endpoint of achieving the pre-operative platelet count threshold (50\u2009×\u2009109/L for minor surgery; or 100\u2009×\u2009109/L for major surgery) and sustaining platelet count levels above the threshold for 1\u2009week after surgical haemostasis is achieved, without the use of rescue treatment. Secondary endpoints include thrombosis, bleeding and patient satisfaction.\n\n\nCONCLUSION\n\u2003The Bridging ITP Trial will evaluate the efficacy and safety of eltrombopag as an alternative to IVIG in the peri-operative setting for patients with ITP. The protocol was designed to provide a management strategy that can be applied in clinical practice. CLINICALTRIALS.\n\n\nGOV IDENTIFIER\nNCT01621204.