Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.
Recruiting
Phase 2
Interventional Study
Chirurgical Intervention
Thrombocytopaenia
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 136 (estimated)
- Sponsor
- Nantes University Hospital · Other
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About This Trial
Romiplostim has demonstrated its efficacy and good tolerance in multiple indications. If the efficacy of Romiplostim is confirmed in this population, thrombocytopenic patients will be able to undergo cardiac surgery, which is generally life-saving, without prior thrombocytopenia.
Patients included in the study will be hospitalized within 15 days of the first administration of the study treatment …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adult patients with no upper age limit,
* Scheduled cardiac surgery with cardiopulmonary bypass,
* Patients with preoperative thrombocytopenia strictly \<150,000/mm3
* Surgery performed with a blood recovery system using centrifugation (Cell Saver type) or equivalent,
* Feasib…
Contacts