BridgeMD
TIC-TAC-SAM « Comparison of two strategies of etoposide initiation in severe sporadic hemophagocytic lymphohistiocytosis in intensive care: a randomized trial »
EU CTIS ID: 2024-511807-41-01
What this study is testing
To compare the effect on the evolution of organ failures of two initiation strategies of etoposide in severe HLH in intensive care: -An early strategy where etoposide is initiated within 12 hours after inclusion. -A delayed strategy where this treatment is initiated only in case of unfavorable evolution (or lack of improvement) after 48 hours
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patient
- Confirmed diagnosis of HLH: • Presence of 5 or more Henter criteria (HLH-04) out of the 6 achievable in routine care (fever, splenomegaly, cytopenias affecting 2 or 3 blood lineages, hypertriglyceridemia or hypofibrinogenemia, hemophagocytosis in bone marrow, spleen or lymph nodes, hyperferritinemia) • Diagnosis of HLH established by the multidisciplinary team caring for the patient
- First episode of HLH
- Admission to intensive care unit
- Presence of one or more organ failures • Circulatory: mBP < 65 mmHg with lactate > 2 mmol/L, or treatment with catecholamines • Respiratory: oxygen therapy > 6L/min or need for non-invasive ventilation, high-flow nasal cannula oxygen therapy, or invasive mechanical ventilation • Renal: stage 2 or higher according to KDIGO criteria, either creatinine 2-2.9 times baseline, or urine output < 0.5 mL/kg/h for 12 hours • Neurological: GCS ≤ 13
You likely can't join if
- Moribund patient with refractory distributive shock: multi-organ failure requiring noradrenaline >2.5 μg/kg/min and imminent risk of death
- Recent vaccination with a live attenuated vaccine
- Hypersensitivityor contraindication to dexamethasone or any of its excipients
- Patients developing SAM within 15 days ofchemotherapy for cancer or malignant blood disease
- Participation in another interventional research study
- Inability to administer etoposide within 12 hours
See the full eligibility criteria
- Adult patient
- Confirmed diagnosis of HLH: • Presence of 5 or more Henter criteria (HLH-04) out of the 6 achievable in routine care (fever, splenomegaly, cytopenias affecting 2 or 3 blood lineages, hypertriglyceridemia or hypofibrinogenemia, hemophagocytosis in bone marrow, spleen or lymph nodes, hyperferritinemia) • Diagnosis of HLH established by the multidisciplinary team caring for the patient
- First episode of HLH
- Admission to intensive care unit
- Presence of one or more organ failures • Circulatory: mBP < 65 mmHg with lactate > 2 mmol/L, or treatment with catecholamines • Respiratory: oxygen therapy > 6L/min or need for non-invasive ventilation, high-flow nasal cannula oxygen therapy, or invasive mechanical ventilation • Renal: stage 2 or higher according to KDIGO criteria, either creatinine 2-2.9 times baseline, or urine output < 0.5 mL/kg/h for 12 hours • Neurological: GCS ≤ 13
- Moribund patient with refractory distributive shock: multi-organ failure requiring noradrenaline >2.5 μg/kg/min and imminent risk of death
- Recent vaccination with a live attenuated vaccine
- Hypersensitivityor contraindication to dexamethasone or any of its excipients
- Patients developing SAM within 15 days ofchemotherapy for cancer or malignant blood disease
- Participation in another interventional research study
- Inability to administer etoposide within 12 hours
- Patient treated with etoposide prior to admission to the intensive care unit
- Hypersensitivity to etoposide or any of its excipients
- Patient not covered by social security
- Patient under legal guardianship, tutelage, or curatorship
- Minor patient
- Pregnant or lactating woman
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.