Platelet Transfusion in Sepsis Trial

Not Applicable

Withdrawn

• Conditions: Thrombocytopenia; Sepsis
• Interventions: Biological: platelet transfusion

• Registration Number: NCT03968484
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-30
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-10
• Study Start: 2020-08-01
• Primary Completion: 2022-08-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
<50.000/µl	platelet transfusion	Transfusion of platelets starting with a platelet count \<50.000/µl
<20.000/µl	platelet transfusion	Transfusion of platelets starting with a platelet count \<20.000/µl

Primary Outcome Measures

Name	Time	Method
Overall survival in 90 day follow-up period	90 days	overall survival at 90 days

Secondary Outcome Measures

Name	Time	Method
all cause mortality at 6 months	6 months	overall survival at 6 months
duration of mechanical ventilation support	28 days	time to extubation
discharge location	90 days	discharge to home, ward, rehabilitation unit, nursing home
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
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