Status:
COMPLETED
TRANSfusion in Patients With Onco-hematological Malignancies ResusciTated From Septic Shock
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Septic Shock
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 remai...
Detailed Description
Septic shock is a frequent complication in patients with malignancies and remains affected with a mortality rate higher than 50%. Red blood cell (RBC) transfusion remains a major issue for critically...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2024
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT03837171
Start Date
March 24 2019
End Date
March 4 2024
Last Update
June 25 2024
Active Locations (20)
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1
CHU Amiens Picardie Site Sud
Amiens, France
2
Hopital Robert Ballanger
Aulnay-sous-Bois, France
3
Hopital Avicenne AP-HP
Bobigny, France
4
CH sud-Francilien
Corbeil, France