Septic ShockPASSNCT02635854
Study of Platelet Activation in Septic Shock Patients
A study testing Septic choc group and Orthopedic surgery group in people with Septic Shock, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Some studies have shown that antiplatelets agents could reduce organ dysfunction in septic shock in mice and human models. Platelets are actors in immunity and their activation can be complicated by tissue damage with vascular occlusions which can lead to organ dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Septic choc group and Orthopedic surgery group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to 5 Jan 2017
- 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
- EXPERIMENTAL GROUP
- Patient who possibly gave an oral agreement to inclusion and may sign a consent once out of intensive care
- Patients hospitalized in general intensive care
- Patient hospitalized for less than 72 hours
- Patient suffering from severe sepsis, whatever their origin, with hypotension (PAs <90mmHg) despite adequate fluid resuscitation and vasoactive requiring the use of amines, with hypoperfusion and / or at least one organ dysfunction ( septic shock)
- Patient with a Sequential Organ Failure Assessment (SOFA) score> 8 (or> 2 in an organ) in the first 24 hours
Show all 11Show fewer
- Patient enjoying a social security scheme or equivalent
- CONTROL GROUP
- Signed informed consent
- Patient seen anesthesia consultation for orthopedic knee prosthesis of laying or hip with a negative balance infectious
- Patient enjoying a social security scheme or equivalent
Who cannot join
- EXPERIMENTAL GROUP
- Patient on safeguarding justice, guardianship
- Patient suffering from a haematological malignancy (leukemia, lymphoma ...)
- Patient suffering from thrombocytopenia or constitutional thrombopathy
- Pregnant
- CONTROL GROUP
Show all 11Show fewer
- Patient on safeguarding justice, guardianship
- Patient with infectious positive balance (dental, urinary tract) prior to surgery
- Patient suffering from a haematological malignancy (leukemia, lymphoma ...)
- Patient suffering from thrombocytopenia or constitutional thrombopathy
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Some studies have shown that antiplatelets agents could reduce organ dysfunction in septic shock in mice and human models. Platelets are actors in immunity and their activation can be complicated by tissue damage with vascular occlusions which can lead to organ dysfunction. Investigators can hypothesize an increase in platelet activation and in leukocyte-platelet aggregates in septic shock.
- Conditions
- Septic Shock
- Being tested
- Septic choc group, Orthopedic surgery group
- Keywords
- leukocyte and platelet aggregates, platelet activation
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Septic choc groupOther
Specific platelet activation markers, circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood at the admission in intensive care unit and 48 hours later for leukocyte-platelet aggregates measurements.
Orthopedic surgery groupOther
Specific platelet activation markers, circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood during the orthopedic surgical anesthesia consultation.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | The test group (Septic choc group) includes 15 patients suffering from septic shock in intensive care unit. Receives: Other: Septic choc group |
| Control group | Other | The control group (Orthopedic surgery group) includes 15 patients recruited from the orthopedic surgical anesthesia consultation programmed for a prosthetic hip or knee pose. Receives: Other: Orthopedic surgery group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of platelets activation markers expression (CD62-P, antibody CD63, CD42b)
Specific platelet activation markers and circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood at the admission in intensive care unit for patients in test group and during the orthopedic surgical anesthesia consultation for patients in control group.
Measured: T0 at the admission in intensive care unit
Level of platelets activation markers expression (CD62-P, CD63, CD42b)
Specific platelet activation markers and circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood 48 hours later admission in intensive care unit only for patients in test group.
Measured: T48 hours after admission in intensive care unit
Secondary outcomes (4)
Rate of leukocyte-platelet aggregates
Measured: T0 at the admission in intensive care unit
Kinetics of leukocyte-platelet aggregates formation
Measured: T0 at the admission in intensive care unit
Correlation of leukocyte-platelet aggregates rate and septic shock severity.
Measured: T0 at the admission in intensive care unit
Comparison of platelet activation in subjects treated or not with antiplatelet agents.
Measured: T0 at the admission in intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionJan 2017
- Study completion5 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny BOUNES, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635854
- Sponsor's protocol ID
- RC31/15/7738
- Other IDs
- 15 7738 02
- Acronym
- PASS
- Status last verified
- Aug 2018
- First submitted
- 14 Dec 2015
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vardon-Bounes F, Garcia C, Piton A, Series J, Gratacap MP, Poette M, Seguin T, Crognier L, Ruiz S, Silva S, Conil JM, Minville V, Payrastre B. Evolution of platelet activation parameters during septic shock in intensive care unit. Platelets. 2022 Aug 18;33(6):918-925. doi: 10.1080/09537104.2021.2007873. Epub 2021 Dec 16.
PubMed 34915822
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Platelet Activation in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT02635854
- Acronym / sponsor ID
- PASS / RC31/15/7738
- Conditions
- Septic Shock
- Keywords
- leukocyte and platelet aggregates, platelet activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 5 Jan 2017 (actual)
- First posted
- 21 Dec 2015 (estimated)
- 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.
Some studies have shown that antiplatelets agents could reduce organ dysfunction in septic shock in mice and human models. Platelets are actors in immunity and their activation can be complicated by tissue damage with vascular occlusions which can lead to organ dysfunction. Investigators can hypothesize an increase in platelet activation and in leukocyte-platelet aggregates in septic shock.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: Septic choc groupThe test group (Septic choc group) includes 15 patients suffering from septic shock in intensive care unit. |
| Control group | Other | Other: Orthopedic surgery groupThe control group (Orthopedic surgery group) includes 15 patients recruited from the orthopedic surgical anesthesia consultation programmed for a prosthetic hip or knee pose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- EXPERIMENTAL GROUP
- Patient who possibly gave an oral agreement to inclusion and may sign a consent once out of intensive care
- Patients hospitalized in general intensive care
- Patient hospitalized for less than 72 hours
- Patient suffering from severe sepsis, whatever their origin, with hypotension (PAs <90mmHg) despite adequate fluid resuscitation and vasoactive requiring the use of amines, with hypoperfusion and / or at least one organ dysfunction ( septic shock)
Key exclusion criteria (11 listed)
- EXPERIMENTAL GROUP
- Patient on safeguarding justice, guardianship
- Patient suffering from a haematological malignancy (leukemia, lymphoma ...)
- Patient suffering from thrombocytopenia or constitutional thrombopathy
- Pregnant
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 |
|---|---|---|
| Septic choc groupSpecific platelet activation markers, circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood at the admission in intensive care unit and 48 hours later for leukocyte-platelet aggregates measurements. | Other | Test group |
| Orthopedic surgery groupSpecific platelet activation markers, circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood during the orthopedic surgical anesthesia consultation. | Other | Control group |
Primary outcome
Level of platelets activation markers expression (CD62-P, antibody CD63, CD42b)
Time frame: T0 at the admission in intensive care unit
Specific platelet activation markers and circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood at the admission in intensive care unit for patients in test group and during the orthopedic surgical anesthesia consultation for patients in control group.
Level of platelets activation markers expression (CD62-P, CD63, CD42b)
Time frame: T48 hours after admission in intensive care unit
Specific platelet activation markers and circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood 48 hours later admission in intensive care unit only for patients in test group.
4 secondary outcomes
Rate of leukocyte-platelet aggregates
Time frame: T0 at the admission in intensive care unit
Kinetics of leukocyte-platelet aggregates formation
Time frame: T0 at the admission in intensive care unit
Correlation of leukocyte-platelet aggregates rate and septic shock severity.
Time frame: T0 at the admission in intensive care unit
Comparison of platelet activation in subjects treated or not with antiplatelet agents.
Time frame: T0 at the admission in intensive care unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 34915822Vardon-Bounes F, Garcia C, Piton A, Series J, Gratacap MP, Poette M, Seguin T, Crognier L, Ruiz S, Silva S, Conil JM, Minville V, Payrastre B. Evolution of platelet activation parameters during septic shock in intensive care unit. Platelets. 2022 Aug 18;33(6):918-925. doi: 10.1080/09537104.2021.2007873. Epub 2021 Dec 16.
- 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.
Fanny BOUNES, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Septic choc group and Orthopedic surgery group in people with Septic Shock, run by University Hospital, Toulouse at 1 site in France.
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 11 inclusion and 11 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: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of platelets activation markers expression (CD62-P, antibody CD63, CD42b) (time frame: T0 at the admission in intensive care unit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02635854, which also lists 1 linked publication.
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 Dec 2025.