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Platelet Transfusion in Sepsis Trial

Primary Purpose

Sepsis, Thrombocytopenia

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

platelet transfusion

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

<50.000/µl

<20.000/µl

Arm Description

Transfusion of platelets starting with a platelet count <50.000/µl

Transfusion of platelets starting with a platelet count <20.000/µl

Outcomes

Primary Outcome Measures

Overall survival in 90 day follow-up period

overall survival at 90 days

Secondary Outcome Measures

all cause mortality at 6 months

overall survival at 6 months

resolution of shock

time to normalization of lactate levels and end of vasopressor therapy

ICU length of stay

length of stay on ICU ward

duration of mechanical ventilation support

time to extubation

renal replacement therapy

frequency and duration of renal replacement therapy

bleeding events

bleeding events requiring transfusion during ICU stay

SOFA score

Sepsis-related organ failure assessment score

discharge location

discharge to home, ward, rehabilitation unit, nursing home

Full Information

NCT ID

NCT03968484

First Posted

May 29, 2019

Last Updated

April 8, 2020

Sponsor

University Hospital Tuebingen

1. Study Identification

Unique Protocol Identification Number

NCT03968484

Brief Title

Platelet Transfusion in Sepsis Trial

Official Title

Platelet Transfusion in Sepsis Trial (PlaTiSep)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Withdrawn

Why Stopped

COVID-19 trials gained priority

Study Start Date

August 1, 2020 (Anticipated)

Primary Completion Date

August 1, 2022 (Anticipated)

Study Completion Date

February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis, Thrombocytopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

<50.000/µl

Arm Type

Experimental

Arm Description

Transfusion of platelets starting with a platelet count <50.000/µl

Arm Title

<20.000/µl

Arm Type

Experimental

Arm Description

Transfusion of platelets starting with a platelet count <20.000/µl

Intervention Type

Biological

Intervention Name(s)

platelet transfusion

Intervention Description

Transfusion of platelets

Primary Outcome Measure Information:

Title

Overall survival in 90 day follow-up period

Description

overall survival at 90 days

Time Frame

90 days

Secondary Outcome Measure Information:

Title

all cause mortality at 6 months

Description

overall survival at 6 months

Time Frame

6 months

Title

resolution of shock

Description

time to normalization of lactate levels and end of vasopressor therapy

Time Frame

5 days

Title

ICU length of stay

Description

length of stay on ICU ward

Time Frame

28 days

Title

duration of mechanical ventilation support

Description

time to extubation

Time Frame

28 days

Title

renal replacement therapy

Description

frequency and duration of renal replacement therapy

Time Frame

28 days

Title

bleeding events

Description

bleeding events requiring transfusion during ICU stay

Time Frame

28 days

Title

SOFA score

Description

Sepsis-related organ failure assessment score

Time Frame

28 days

Title

discharge location

Description

discharge to home, ward, rehabilitation unit, nursing home

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Rosenberger, Prof.

Organizational Affiliation

University hospital Tübingen

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Platelet Transfusion in Sepsis Trial

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