Platelet Transfusion in Sepsis Trial

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03968484
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Anticipated Duration (Months): 30

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Thrombocytopenia	Biological: platelet transfusion	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Platelet Transfusion in Sepsis Trial (PlaTiSep)
• Anticipated Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: <50.000/µl Transfusion of platelets starting with a platelet count <50.000/µl	Biological: platelet transfusion; Transfusion of platelets
Experimental: <20.000/µl Transfusion of platelets starting with a platelet count <20.000/µl	Biological: platelet transfusion; Transfusion of platelets

Outcome Measures

Primary Outcome Measures

1. Overall survival in 90 day follow-up period [90 days]

   overall survival at 90 days

Secondary Outcome Measures

1. all cause mortality at 6 months [6 months]

   overall survival at 6 months

2. resolution of shock [5 days]

   time to normalization of lactate levels and end of vasopressor therapy

3. ICU length of stay [28 days]

   length of stay on ICU ward

4. duration of mechanical ventilation support [28 days]

   time to extubation

5. renal replacement therapy [28 days]

   frequency and duration of renal replacement therapy

6. bleeding events [28 days]

   bleeding events requiring transfusion during ICU stay

7. SOFA score [28 days]

   Sepsis-related organ failure assessment score

8. discharge location [90 days]

   discharge to home, ward, rehabilitation unit, nursing home

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

• Principal Investigator: Peter Rosenberger, Prof., University hospital Tübingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT03968484
• Other Study ID Numbers: PlaTiSep
• First Posted: May 30, 2019
• Last Update Posted: Apr 10, 2020
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sepsis; Toxemia; Thrombocytopenia

Study Results

No Results Posted as of Apr 10, 2020