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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03968484
Other study ID # PlaTiSep
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date February 1, 2023

Study information

Verified date May 2019
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 1, 2023
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
platelet transfusion
Transfusion of platelets

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Outcome

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