New drug aims to raise platelets in sepsis patients
NCT ID NCT07595133
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a drug called romiplostim in 280 sepsis patients with very low platelet counts (under 50). The drug is given as a weekly shot to try to raise platelet levels. Researchers will compare it to a standard treatment and check how well it works after 7 days, as well as survival and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- romiplostim (a platelet-boosting drug)
- What this could lead to
- If it works, this could offer a new way to quickly raise platelet counts in sepsis patients, potentially reducing bleeding risks and improving survival.
- What could go wrong
- This is a very early phase 1 trial, so the drug may not work as hoped or could cause unexpected side effects. Results may not apply to all sepsis patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 280 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years old, gender unrestricted. * Meeting the diagnostic criteria of sepsis 3.0, namely: a) confirmed or suspected infection; b) organ dysfunction caused by infection, that is, Sequential Organ Failure Assessment (SOFA) score ≥ 2 points. If organ dysfunction is known to exist before infection, that is, the SOFA score is greater than 0 points, then the SOFA score must increase by ≥ 2 points after the infection occurs. * Platelet count ≤ 50×109/L. * The subjects must fully understand and be able to comply with the requirements of the research protocol, and voluntarily sign the informed consent form. Exclusion Criteria: * Subjects who are allergic to romiplostim N01 or thrombopoietin, or who have previously received romiplostim N01 or thrombopoietin treatment but showed no therapeutic effect. * Subjects who have undergone cardiopulmonary resuscitation or have end-stage liver or kidney failure. * Subjects with thrombocytopenia caused by hematological diseases, or with other hypercoagulable state diseases, recent thrombosis, or acute active bleeding. * Subjects who have participated in other drug clinical studies within one month. * Subjects who have used anticoagulants or antiplatelet drugs (such as aspirin, clopidogrel, etc.) within three weeks. * Subjects who have received platelet-raising treatment (such as methylprednisolone, platelet transfusion, intravenous immunoglobulin or TPO antirheumatic drugs) within two weeks. * Subjects who have received immunomodulatory agent treatment within six months. * Subjects who have undergone splenectomy within six months. * Subjects with a history of radiotherapy or chemotherapy for malignant tumors or with advanced malignant tumors. * Subjects who have previously received allogeneic stem cell transplantation or organ transplantation. * Subjects with severe cardiovascular and cerebrovascular diseases, severe trauma, major surgery, or other causes of major bleeding. * Subjects who were transferred out or died within 24 hours of admission (or ICU). * Subjects with known or suspected immunosuppression history, including invasive opportunistic infection history (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis); or subjects with complex long-term infections. * Women who are currently pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study; and men whose partners plan to become pregnant during the study. * Subjects whom the investigator deems unsuitable for participation in this study for any other reason.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can two blood markers catch sepsis before it turns deadly?
- Two cheap blood ratios put to the test as sepsis death predictors
- Can a computer model speed up sepsis blood tests?