Immune Thrombocytopenic Purpura Clinical Trial
Official title:
Treatment of thromBocytopenia With EltRombopag or Intravenous Immune Globulin (IVIG) Before and DurING Invasive Procedures in Patients With Immune ThrombocytoPenia- BRIDGING ITP Study
Verified date | September 2020 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a study to investigate if eltrombopag can be used instead of Intravenous Immune Globulin (IVIG) in patients with ITP, to adequately raise their platelet count when they undergo minor or major surgery. Eltrombopag is a daily, oral pill approved for treatment of ITP. IVIG is a blood product frequently used to treat ITP. Patients with ITP who need surgery have to get treatment to increase their platelet count. IVIG is commonly used for this purpose but eltrombopag may be more effective and convenient for patients.
Status | Completed |
Enrollment | 74 |
Est. completion date | August 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Primary or secondary ITP; - Platelet count below surgical platelet count threshold (50 x10^9/L for minor surgery; 100 x 10^9/L for major surgery); - 18 years of age or older; - On stable doses of concomitant ITP medications (i.e the dose administered has not changed) or no ITP medication for at least 2 weeks; - At least 3-weeks lead time available between randomization and scheduled surgery; - IVIG and Eltrombopag are acceptable ITP treatment options for this patient; - Able to provide informed consent. Exclusion Criteria: - Pregnancy or breastfeeding; - Treatment with IVIG within the last 2 weeks; - Treatment with a thrombopoietin receptor agonist (eltrombopag or romiplostim) within the last 4 weeks; - AST, ALT above 2X upper limit of normal; - Bilirubin above 1.5X upper limit of normal in the absence of clinically benign liver disorder (eg. Gilberts syndrome); - Deep vein thrombosis, myocardial infarction, thrombotic stroke or arterial thrombosis in the last 12 months; - History of bone marrow reticulin or fibrosis; - Known liver cirrhosis; - Active malignancy (defined as requiring treatment or palliation within the last 6 months); - Any additional laboratory test result, health related illness or other diagnosis which, in the opinion of the treating physician, may put the subject's health or safety at risk. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | Hamilton Health Sciences | Hamilton | Ontario |
Canada | London Health Sciences Center | London | Ontario |
Canada | Hopital Maisonneuve-Rosemont | Montreal | Quebec |
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | Ottawa Hospital | Ottawa | Ontario |
Canada | St.Micheal's Hospital | Toronto | Ontario |
Canada | Sunnybrook Hospital | Toronto | Ontario |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Netherlands | The Haga Hospital | The Hague |
Lead Sponsor | Collaborator |
---|---|
McMaster University | GlaxoSmithKline, Hamilton Health Sciences Corporation, Novartis |
Canada, Netherlands,
Arnold DM, Heddle NM, Cook RJ, Hsia C, Blostein M, Jamula E, Sholzberg M, Lin Y, Kassis J, Larratt L, Tinmouth A, Amini S, Schipperus M, Lim W, Vishnu P, Warner M, Carruthers J, Li N, Lane S, Kelton JG. Perioperative oral eltrombopag versus intravenous im — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Achievement of a platelet count level that is above the platelet count threshold for surgery preoperatively and that is maintained above the threshold during the post-hemostasis period without the use of rescue treatment | Threshold is a platelet count of 50 x 10^9/L for minor surgery and 100 x 10^9/L for major surgery. | For a the period of time from the final pre-operative visit until 7 days after surgical hemostasis is achieved | |
Secondary | Time to treatment failure | Time to the occurrence of a platelet count level below the designated threshold, or the administration of rescue treatment | During the period from the final pre-operative visit until 7 days after surgical hemostasis is achieved | |
Secondary | Surgical delays or cancellations | Proportion of patients with surgical delays or cancellations | Measured at time of planned surgery | |
Secondary | Bleeding | Graded as per the ITP bleeding score | During treatment and follow up (on average, 8 weeks from starting treatment) | |
Secondary | Thrombocytosis | Platelet count >400 x 10^9/L | During treatment and follow up (on average, 8 weeks from starting treatment) | |
Secondary | Blood product transfusions | Proportion of patients requiring platelet, red blood cells and plasma transfusions | During treatment and follow up (on average, 8 weeks from starting treatment) | |
Secondary | Rescue treatment | New ITP treatment (typically platelet transfusions, high dose IVIG or high dose corticosteroids) or an increased dose of existing ITP treatment administered to increase platelet counts above threshold | During the period from the final pre-operative visit until 7 days after surgical hemostasis is achieved | |
Secondary | Platelet count change over time | Trend of all platelet count measurements in the trial | During treatment and follow up (on average, 8 weeks from starting treatment) | |
Secondary | Patient satisfaction with treatment | Assessed using the Treatment Satisfaction Questionnaire for Medications Score vII (which incorporates effectiveness, convenience, side effects, and overall satisfaction) | Immediately before surgery (final pre-op visit) and 7 days (+/- 2 days) after surgical hemostasis is achieved | |
Secondary | Hospitalizations | Unanticipated admissions to hospital or prolongation of hospitalization | During treatment and follow up (on average, 8 weeks from starting treatment) | |
Secondary | Thrombosis | Symptomatic thrombotic events confirmed with diagnostic imaging | During treatment and follow up (on average, 8 weeks from starting treatment) | |
Secondary | Adverse Events | Defined using the Common Terminology Criteria for Adverse Events v3.0 | During treatment and follow up (on average, 8 weeks from starting treatment) |
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