Platelet Transfusion in Sepsis Trial

NCT03968484 — Not applicable, Withdrawn, University Hospital Tuebingen

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Platelet Transfusion in Sepsis Trial (PlaTiSep)

Registry	NCT03968484
Status	Withdrawn - COVID-19 trials gained priority
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Sponsor	University Hospital Tuebingen (Other)
Conditions	Sepsis, Thrombocytopenia
Interventions	platelet transfusion (Biological)
Dates	start 2020-08-01 (estimated), primary completion 2022-08-01 (estimated), completion 2023-02-01 (estimated), first posted 2019-05-30, last updated 2020-04-10

-Summary

Platelets are important mediators of an inflammatory response and a key component of the innate immune system to defend the human body against invading pathogens. However, little evidence exists regarding the number of platelets that should be used als transfusion threshold in septic patients. In this trial platelet transfusion will be performed with either <50000/µl or <20000/µl as a trigger.

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+Arms and interventions

Arm	Type	Interventions	Description
<50.000/µl	Experimental	Biological: platelet transfusion	Transfusion of platelets starting with a platelet count <50.000/µl
<20.000/µl	Experimental	Biological: platelet transfusion	Transfusion of platelets starting with a platelet count <20.000/µl

platelet transfusion (Biological): Transfusion of platelets

+Outcome measures

Primary outcomes

Overall survival in 90 day follow-up period [90 days]: overall survival at 90 days

Secondary outcomes

all cause mortality at 6 months [6 months]: overall survival at 6 months
resolution of shock [5 days]: time to normalization of lactate levels and end of vasopressor therapy
ICU length of stay [28 days]: length of stay on ICU ward
duration of mechanical ventilation support [28 days]: time to extubation
renal replacement therapy [28 days]: frequency and duration of renal replacement therapy
bleeding events [28 days]: bleeding events requiring transfusion during ICU stay
SOFA score [28 days]: Sepsis-related organ failure assessment score
discharge location [90 days]: discharge to home, ward, rehabilitation unit, nursing home

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Sepsis defined as alteration of SOFA score (Sepsis-related organ failure assessment score) >2 points (Sepsis-3 definition)
* platelet count <50.000/µl

Exclusion Criteria:

* Age less than 18 years
* patients with immune thrombocytopenia
* major bleeding in the last 72 hours or ongoing major bleeding
* patient, surrogate or physician not committed to full intensive care support
* pregnancy

+Investigators

Peter Rosenberger, Prof., Principal investigator, University Hospital Tuebingen