Platelet Transfusion in Sepsis Trial

Platelet Transfusion in Sepsis Trial (PlaTiSep)

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03968484

Enrollment

Registered

2019-05-30

Start date

2020-08-01

Completion date

2023-02-01

Last updated

2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Thrombocytopenia

Brief 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.

Interventions

BIOLOGICALplatelet transfusion

Transfusion of platelets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Overall survival in 90 day follow-up period	90 days	overall survival at 90 days

Secondary

Measure	Time frame	Description
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
all cause mortality at 6 months	6 months	overall survival at 6 months
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
renal replacement therapy	28 days	frequency and duration of renal replacement therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026