Platelet Transfusion in Sepsis Trial

Sepsis Clinical Trial

Official title:

Platelet Transfusion in Sepsis Trial (PlaTiSep)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03968484
• Other study ID #: PlaTiSep
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Sepsis
• Thrombocytopenia
• Toxemia

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