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Completed
NCT03515447
Romiplostim in Thoracic Transplantation
Conditions: Thrombocytopenia
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Enrollment: 30
Sponsor: Nantes University Hospital
Location: CHU de Nantes Nantes
Summary
The investigators developed a platelet transfusion saving strategy based on thrombopoietin administration in heart or lung transplantation (HLT) patients or assist device implantation in bridge-to-transplantation (BTT) or bridge to-decision (BTD). This strategy was applied from May 2014 to October 2015 in patients whose platelet counts were below 100 Giga per liter (G/L). As part of a health care quality improvement project, the investigators evaluated this strategy in a before/after design. January 2010 to December 2013 constituted the before period.
Eligibility Criteria
Inclusion Criteria:
* Patients admitted in ICU after HLT, BTT or BTD assist device implantation with platelet counts below 100G/L at least once in the post-operative period
Exclusion Criteria:
* age under 18 or over 65, combined heart and lung transplantation, multiple organ dysfunction syndrome (MODS), pericardial effusion, active surgical bleeding, assist device dysfunction or suspected/diagnosed heparin-induced thrombocytopenia. We also excluded patients with myelodysplastic or myeloproliferative syndrome, hematological malignancy, severe liver cirrhosis with a Child-Pugh score superior to 6, receiving antiplatelet therapy, aplasia diagnosed on bone marrow analyses, pregnancy, thrombophilia, prior pulmonary embolism or stroke in the previous 6 months. Thrombophilia was defined as factor V Leyden mutation, activated protein C resistance, protein S deficiency, protein C deficiency, prothrombin gene mutation, factor VIII excess, ATIII deficiency or antiphospholipid syndrome. For the assistance population, the protocol also excluded destination-therapy devices or patients with transplantation contraindications
Source: ClinicalTrials.gov (NCT03515447). StuddyBuddy aggregates publicly available trial information.