Platelet Transfusion in Sepsis Trial | NCT03968484

Studies
Platelet Transfusion in Sepsis Trial

NCT03968484

Sponsor

University Hospital Tuebingen

Status

Withdrawn

Last Update Posted

Apr 10, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Sepsis
Thrombocytopenia

Interventions

platelet transfusion

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID-19 trials gained priority

Expanded Access Info

Start Date

Aug 1, 2020Estimated

Primary Completion Date

Aug 1, 2022Estimated

Completion Date

Feb 1, 2023Estimated

First Submitted Date

May 29, 2019

First Submission Date that Met QC Criteria

May 29, 2019

First Posted Date

May 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2020

Last Update Posted Date

Apr 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
<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

Name	Type	Description	Arm Group Labels	Other Names
platelet transfusion	Biological	Transfusion of platelets	<20.000/µl <50.000/µl

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival in 90 day follow-up period	overall survival at 90 days	90 days

Secondary Outcomes

Measure	Description	Time Frame
all cause mortality at 6 months	overall survival at 6 months	6 months
resolution of shock	time to normalization of lactate levels and end of vasopressor therapy

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Rosenberger, Prof.	University Hospital Tübingen	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D013921	Thrombocytopenia

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017713	Platelet Transfusion

Ancestor Terms

ID	Term
D016913	Blood Component Transfusion
D001803	Blood Transfusion
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided