NCT03968484

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2020

Typical duration for not_applicable sepsis

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

April 10, 2020

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

May 29, 2019

Last Update Submit

April 8, 2020

Conditions

SepsisThrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Overall survival in 90 day follow-up period

    overall survival at 90 days

    90 days

Secondary Outcomes (8)

  • all cause mortality at 6 months

    6 months

  • resolution of shock

    5 days

  • ICU length of stay

    28 days

  • duration of mechanical ventilation support

    28 days

  • renal replacement therapy

    28 days

  • +3 more secondary outcomes

Study Arms (2)

<50.000/µl

EXPERIMENTAL

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

Biological: platelet transfusion

<20.000/µl

EXPERIMENTAL

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

Biological: platelet transfusion

Interventions

platelet transfusionBIOLOGICAL

Transfusion of platelets

<20.000/µl<50.000/µl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SepsisThrombocytopenia

Interventions

Platelet Transfusion

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBlood TransfusionBiological TherapyTherapeutics

Study Officials

  • Peter Rosenberger, Prof.

    University Hospital Tübingen

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

May 30, 2019

Study Start

August 1, 2020

Primary Completion

August 1, 2022

Study Completion

February 1, 2023

Last Updated

April 10, 2020

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share