Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.

What Was Tested

This registered phase 2 trial tested Romiplostim.

It had two arms (groups): Romiplostim (experimental) and NaCl (placebo comparator).

Injection sc.

Injection sc.

The registry classes the interventions as drug.

Who Took Part

136 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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,. Feasibility of a first injection (Romiplostim or Placebo) between D-14 and D-10 before surgery,.

The full record lists 6 inclusion and 29 exclusion criteria; among the exclusions: inability to administer the first injection of romiplostim or placebo within 10 days prior to surgery,; cardiac surgery without cardiopulmonary bypass,; planned use of aprotinin as an antifibrinolytic agent during surgery,.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Romiplostim study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Romiplostim, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2026-07-16 with completion listed for 2028-12-01.

It ran at 8 sites in France (8).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 20 secondary outcomes, for example Transfusion of platelet concentrate, Transfusion of platelet concentrate, Transfusion of platelet concentrate, Transfusion of red blood cell concentrate, Transfusion of red blood cell concentrate and Transfusion of red blood cell concentrate.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Romiplostim in 136 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.