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Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.

Study acronym: CT-PLATE
StatusRecruiting
PhasePhase 2
Started2026-07-16
View on ClinicalTrials.gov ↗

Amendment history

2026-07-23
minor
Study Status, Eligibility, Contacts/Locations v3
Start dateestimated 2026-09-01→confirmed 2026-07-16
Eligibility criteria+180 characters
[...] gery without cardiopulmonary bypass, Coronary artery bypass graftinggraft surgery due to one or more significant coronary stenoses presenting with unstable angina (defined by anginal pain at rest, or with minimal exertion, or pain that has recently worsened), Tangential filtration blood recovery system (i-SEP SAME® t [...] e of aprotinin as an antifibrinolytic agent during surgery, PatientPatients treated with contraindicationclopidogrel (Plavix) or ticagrelor who cannot switch to discontinuation of all antiplatelet therapy before surgery (with discontinuation at least 3 days before surgery for acety [...] [...]
Study sitescontacts updated at 1 of 8 sites
2026-03-31
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-04-01→2028-12-01
Completion date2028-04-01→2028-12-01
Start date2026-01-01→2026-09-01
Study sitesdetails revised at 8 of 8 sites
2025-12-15
minor
Study Status, Arms and Interventions v1
Re-verified, no change to tracked fields
2025-12-01
minor
Original filing
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 and will be closely monitored clinically and biologically for at least 10 days after surgery. The occurrence of an adverse event can therefore be quickly detected and managed. Collectively, "Patient Blood Management" strategies are mainly focused on the management of preoperative anemia. If positive, this study will enrich the therapeutic arsenal available for optimizing patients in preparation for major surgery. As no major collective complications are expected, the collective benefit/risk ratio also appears favorable.
Trial Details
NCT Number NCT07278661
Lead Sponsor Nantes University Hospital
Conditions Chirurgical Intervention, Thrombocytopaenia
Enrollment 136 participants
Start Date 2026-07-16
Primary Completion 2028-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-24