Platelet Transfusion in Sepsis Trial

NCT ID: NCT03968484

Last Updated: 2020-04-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2023-02-01

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.

Conditions

Sepsis; Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

<50.000/µl

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

Group Type: EXPERIMENTAL

platelet transfusion

Intervention Type: BIOLOGICAL

Transfusion of platelets

<20.000/µl

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

Group Type: EXPERIMENTAL

platelet transfusion

Intervention Type: BIOLOGICAL

Transfusion of platelets

Interventions

platelet transfusion

Transfusion of platelets

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Rosenberger, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tübingen

Other Identifiers

PlaTiSep

Identifier Type: -

Identifier Source: org_study_id