SepsisNCT03968484
Platelet Transfusion in Sepsis Trial
A study testing platelet transfusion in people with Sepsis and Thrombocytopenia, run by University Hospital Tuebingen.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Thrombocytopenia
- What is being tested?
- platelet transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sepsis defined as alteration of SOFA score (Sepsis-related organ failure assessment score) >2 points (Sepsis-3 definition)
- platelet count <50.000/µl
Who cannot join
- 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
About this study
Official title: Platelet Transfusion in Sepsis Trial (PlaTiSep)
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
- Being tested
- platelet transfusion
- Medical subject headings
- Sepsis, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet transfusionBiological
Transfusion of platelets
| Study group | Role | What they receive |
|---|---|---|
| <50.000/µl | Experimental | Transfusion of platelets starting with a platelet count <50.000/µl Receives: Biological: platelet transfusion |
| <20.000/µl | Experimental | Transfusion of platelets starting with a platelet count <20.000/µl Receives: Biological: platelet transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival in 90 day follow-up period
overall survival at 90 days
Measured: 90 days
Secondary outcomes (8)
all cause mortality at 6 months
overall survival at 6 months
Measured: 6 months
resolution of shock
time to normalization of lactate levels and end of vasopressor therapy
Measured: 5 days
ICU length of stay
length of stay on ICU ward
Measured: 28 days
duration of mechanical ventilation support
time to extubation
Measured: 28 days
renal replacement therapy
frequency and duration of renal replacement therapy
Measured: 28 days
bleeding events
bleeding events requiring transfusion during ICU stay
Measured: 28 days
SOFA score
Sepsis-related organ failure assessment score
Measured: 28 days
discharge location
discharge to home, ward, rehabilitation unit, nursing home
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Aug 2020 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Why it stopped: COVID-19 trials gained priority
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Rosenberger, Prof., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968484
- Sponsor's protocol ID
- PlaTiSep
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Transfusion in Sepsis Trial (PlaTiSep)
- ClinicalTrials.gov ID
- NCT03968484
- Acronym / sponsor ID
- PlaTiSep
- Conditions
- Sepsis, Thrombocytopenia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 trials gained priority
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| <50.000/µl | Experimental | Biological: platelet transfusionTransfusion of platelets starting with a platelet count <50.000/µl |
| <20.000/µl | Experimental | Biological: platelet transfusionTransfusion of platelets starting with a platelet count <20.000/µl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sepsis defined as alteration of SOFA score (Sepsis-related organ failure assessment score) >2 points (Sepsis-3 definition)
- platelet count <50.000/µl
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet transfusionTransfusion of platelets | Biological | <20.000/µl, <50.000/µl |
Primary outcome
Overall survival in 90 day follow-up period
Time frame: 90 days
overall survival at 90 days
8 secondary outcomes
all cause mortality at 6 months
Time frame: 6 months
resolution of shock
Time frame: 5 days
ICU length of stay
Time frame: 28 days
duration of mechanical ventilation support
Time frame: 28 days
renal replacement therapy
Time frame: 28 days
bleeding events
Time frame: 28 days
SOFA score
Time frame: 28 days
discharge location
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rosenberger, Prof. principal investigator
University Hospital Tuebingen
Questions about this trial
What is this clinical trial studying?
A study testing platelet transfusion in people with Sepsis and Thrombocytopenia, run by University Hospital Tuebingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival in 90 day follow-up period (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.