Thromb Haemost 2019; 119(03): 500-507
DOI: 10.1055/s-0038-1677531
Trial Protocol Design Paper
Georg Thieme Verlag KG Stuttgart · New York

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

Donald M. Arnold
1  Department of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada
2  McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
3  Canadian Blood Services, Hamilton, Ontario, Canada
4  Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada
,
Erin Jamula
2  McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
,
Nancy M. Heddle
1  Department of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada
2  McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
,
Richard J. Cook
5  Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada
,
Cyrus Hsia
6  Division of Hematology, Department of Medicine, University of Western Ontario, London, Ontario, Canada
,
Michelle Sholzberg
7  Departments of Medicine and Laboratory Medicine & Pathobiology, University of Toronto, Toronto, Ontario, Canada
,
Yulia Lin
8  Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada
,
Jeannine Kassis
9  Faculty of Medicine, Université de Montréal, Montreal, Quebec, Canada
,
Mark Blostein
10  Department of Medicine, McGill University, Montreal, Quebec, Canada
,
Loree Larratt
11  Division of Hematology, University of Alberta, Edmonton, Alberta, Canada
,
Sufia Amini
12  Department of Hematology, Haga Teaching Hospital, The Hague, The Netherlands
,
Martin Schipperus
12  Department of Hematology, Haga Teaching Hospital, The Hague, The Netherlands
,
Julie Carruthers
2  McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
,
Shannon J. Lane
2  McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
,
Na Li
2  McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
,
John G. Kelton
1  Department of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada
2  McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
4  Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada
› Author Affiliations
Funding The Bridging ITP Trial was funded by Novartis. Program funding for the McMaster Center for Transfusion Research was provided by Canadian Blood Services, the Federal Government of Canada (Health Canada) and Provincial and Territorial Ministries of Health.
Further Information

Publication History

19 June 2018

29 November 2018

Publication Date:
27 January 2019 (eFirst)

Abstract

Background The 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.

Methods We designed a multi-centre, non-inferiority randomized trial comparing daily oral eltrombopag starting 3 weeks pre-operatively, and IVIG administered 1 week pre-operatively for patients with ITP requiring a platelet count increase prior to surgery. Starting dose of eltrombopag is 50 mg daily with a weekly pre-operative dose titration schedule, and treatment is continued for 1 week after surgical haemostasis is achieved. IVIG is administered at a dose of 1 to 2 g/kg 1 week pre-operatively with the allowance for a second dose within 1 week 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 × 109/L for minor surgery; or 100 × 109/L for major surgery) and sustaining platelet count levels above the threshold for 1 week after surgical haemostasis is achieved, without the use of rescue treatment. Secondary endpoints include thrombosis, bleeding and patient satisfaction.

Conclusion The 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.gov Identifier NCT01621204.