Health TrialsbyHealthPanel

Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.

ConditionsChirurgical InterventionThrombocytopaenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital

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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

Inability to administer the first injection of Romiplostim or Placebo within 10 days prior to surgery,

Cardiac surgery without cardiopulmonary bypass,

Coronary artery bypass graft 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® type) planned for intraoperative use or absence of intraoperative blood recovery system due to investigator choice or availability issues,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nplate

    Drug

    The dosage for this first injection will be: * 2 µg/kg for patients with a platelet count at inclusion between 149,000 and 100,000/mm3 * 3 µg/kg for patients with a platelet count strictly below 100,000/mm3

  • NaCl %0.9

    Drug

    NaCl (Sodium chloride) 0.9% administered subcutaneously

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: RomiplostimExperimental treatment 1 intervention
Group B: NaClPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy

Lowest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery

Time frame
Day 7

Secondary outcomes

1

Transfusion of platelet concentrate

Number of transfusion of platelet concentrate

Time frame
Day 1
2

Transfusion of platelet concentrate

Number of transfusion of platelet concentrate

Time frame
Day 7
3

Transfusion of platelet concentrate

Number of transfusion of platelet concentrate

Time frame
Day 28
4

Transfusion of red blood cell concentrate

Number of transfusion of red blood cell concentrate

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nantes University Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now