Clinical trial · Interventional
TRANSfusion in Patients With Onco-hematological Malignancies ResusciTated From Septic Shock
Stratégie Transfusionnelle érythrocytaire Dans la réanimation du Choc Septique du Patient d'Onco-hématologie : Essai randomisé Multicentrique TRANSPORT [TRANSfusion in Patients With Onco-hematological Malignancies ResusciTated From Septic Shock]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Septic shock is a frequent complication associated with high mortality in patients with malignancies. The best transfusion strategy (restrictive or liberal) for the resuscitation of septic shock remains a controversial issue, in relation with potentially discrepant goals of tissue oxygenation and transfusion sparing. In this study, the investigators propose to address the efficacy of two RBC transfusion strategies (liberal or restrictive) in restoring appropriate tissue oxygenation as well as their tolerance. The investigators designed a prospective randomized multicenter trial aimed at comparing liberal and restrictive RBC transfusion strategies applied during the first 48 hours of resuscitation in cancer patients with septic shock and anemia.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Septic Shock | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liberal Red blood cell transfusion | Biological | — | UNRESOLVED |
| Restrictive Red blood cell transfusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Liberal strategy
- description
- Maintain a hemoglobin level \> 9 g/dL during the first 48 hours of resuscitation of septic shock
- interventionNames
- Biological: Liberal Red blood cell transfusion
- type
- EXPERIMENTAL
- label
- Restrictive strategy
- description
- Maintain a hemoglobin level \> 7 g/dL during the resuscitation of septic shock
- interventionNames
- Biological: Restrictive Red blood cell transfusion
Primary outcomes (1)
- measure
- Tissue oxygenation
- timeFrame
- 12 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Evolutive (complete remission \< 2 years) malignant solid tumor or chronic or acute hematological malignancy * Septic shock defined as: * Presumed or documented infection * Acute circulatory failure defined as hypotension requirement of vasoactive drugs for more than one hour (norepinephrine or epinephrine ≥ 0.1 µg/kg/min) * Tissue hypoxia defined by arterial lactate level \> 2 mmol/L within 3 hours prior to inclusion * Hemoglobin level \< 9 g/dL * Informed consent from patients or surrogates Exclusion Criteria: * Acute life-threatening bleeding * Ongoing acute coronary syndrome or any other acute ischemic condition * End-of-life decisions at the time of ICU admission * Refusal of transfusions for personal beliefs * Lack of social security coverage * Pregnancy or breastfeeding
References
Publications (0)
Data not yet available