Platelet Transfusion in Sepsis Trial

Platelet Transfusion in Sepsis Trial (PlaTiSep)

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.

Study Overview

• Status: Withdrawn
• Conditions: Sepsis; Thrombocytopenia
• Intervention / Treatment: Biological: platelet transfusion

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: <50.000/µl; Transfusion of platelets starting with a platelet count <50.000/µl	Biological: platelet transfusion; Transfusion of platelets
EXPERIMENTAL: <20.000/µl; Transfusion of platelets starting with a platelet count <20.000/µl	Biological: platelet transfusion; Transfusion of platelets

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2020
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): February 1, 2023

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (ACTUAL): May 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Blood Platelet Disorders; Sepsis; Toxemia; Thrombocytopenia
• Other Study ID Numbers: PlaTiSep

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No