Septic ShockNCT03716310
Platelet Reactivity in Septic Shock
An observational study of Septic Shock and Thrombocytopenia, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
Coagulation disorders and thrombocytopenia are common in patients with septic shock. Despite the clinical relevance of sepsis-induced thrombocytopenia, few studies have focused on the prediction of thrombocytopenia in this setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Thrombocytopenia, Sepsis
- What is being tested?
- platelet responsiveness evaluation
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2017to 30 Aug 2018
- Phase
- Observational
- 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
Study population: Patients in intensive care unit
Who may be able to join
- diagnosis of septic shock
- platelet count >150*103/mcL.
Who cannot join
- age <18 years
- history of any hematologic disorder
- chronic liver failure
- previous chemotherapy
- transfusion of platelet during the previous 4 weeks
- renal replacement therapy before ICU admission
Show all 10Show fewer
- history of antiplatelet therapy during the 8 days before inclusion
- history of heparin-induced thrombocytopenia (HIT) or other acquired or induced thrombocytopenia
- occurrence of HIT (defined as HIT score over 3)
- active bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impaired Platelet Reactivity as an Early Biomarker for Sepsis-related Thrombocytopenia
Coagulation disorders and thrombocytopenia are common in patients with septic shock. Despite the clinical relevance of sepsis-induced thrombocytopenia, few studies have focused on the prediction of thrombocytopenia in this setting. The aim of this study was to evaluate whether platelets aggregometry and markers of platelets activation, such as mean platelet volume or platelet volume distribution width, could predict sepsis-induced thrombocytopenia in patients with septic shock and normal platelet count on the day of diagnosis.
- Conditions
- Septic Shock, Thrombocytopenia, Sepsis, Platelet Aggregation, Disseminated Intravascular Coagulation
- Being tested
- platelet responsiveness evaluation
- Medical subject headings
- Shock, Septic, Thrombocytopenia, Sepsis, Disseminated Intravascular Coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet responsiveness evaluationDiagnostic test
Blood samples were anticoagulated with 0.129 mmol/L of sodium citrate and then centrifugated for 10 min at 200 rpm; platelets aggregation was assessed with an AggRAM Advanced Modular System light transmittance aggregometer (Helena Laboratories, Beaumont, Texas, USA). Low-molecular-weight heparin (LMWH) was given at least 8 hours before any blood aggregation sample. Agonist used to initiate aggregation test were: -Adenosine diphosphate (ADP) to assess P2Y12-dependent platelet aggregation; (20 ng) - Arachidonic acid (AA) to assess cyclooxygenase-dependent platelet Adenosine diphosphate aggregation (1 mcg) - thrombin receptor-activating peptide-6 (TRAP-6) to assess protease-activated receptor 1-dependent platelet aggregation. Max aggregation reached (Aggmax), the slope of the curve (slope) and the latency time (lat) were analyzed for each agonist.
| Study group | Role | What they receive |
|---|---|---|
| septic shock patients | Inclusion criteria of the study were diagnosis of septic shock and a platelet count >150*103/mcL. Receives: Diagnostic Test: platelet responsiveness evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of sepsis-induced thrombocytopenia
Occurence of platelet count <150 *103/μL
Measured: 5 days after study inclusion
Secondary outcomes (3)
life-threatening bleeding
Measured: After 28 days from study inclusion
90-day mortality
Measured: after 90 days from study enrollment
number of Red blood cells (RBC) packs transfused during ICU stay
Measured: After 28 days from study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Apr 2017
- Primary completion30 May 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Fogagnolo, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716310
- Sponsor's protocol ID
- Sepsisplt
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Campo G, Valgimigli M, Gemmati D, Percoco G, Tognazzo S, Cicchitelli G, Catozzi L, Malagutti P, Anselmi M, Vassanelli C, Scapoli G, Ferrari R. Value of platelet reactivity in predicting response to treatment and clinical outcome in patients undergoing primary coronary intervention: insights into the STRATEGY Study. J Am Coll Cardiol. 2006 Dec 5;48(11):2178-85. doi: 10.1016/j.jacc.2005.12.085. Epub 2006 Nov 13.
PubMed 17161242Dewitte A, Lepreux S, Villeneuve J, Rigothier C, Combe C, Ouattara A, Ripoche J. Blood platelets and sepsis pathophysiology: A new therapeutic prospect in critically [corrected] ill patients? Ann Intensive Care. 2017 Dec 1;7(1):115. doi: 10.1186/s13613-017-0337-7.
PubMed 29192366
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Platelet Reactivity as an Early Biomarker for Sepsis-related Thrombocytopenia
- ClinicalTrials.gov ID
- NCT03716310
- Acronym / sponsor ID
- Sepsisplt
- Conditions
- Septic Shock, Thrombocytopenia, Sepsis, Platelet Aggregation, Disseminated Intravascular Coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 23 Oct 2018 (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.
Coagulation disorders and thrombocytopenia are common in patients with septic shock. Despite the clinical relevance of sepsis-induced thrombocytopenia, few studies have focused on the prediction of thrombocytopenia in this setting. The aim of this study was to evaluate whether platelets aggregometry and markers of platelets activation, such as mean platelet volume or platelet volume distribution width, could predict sepsis-induced thrombocytopenia in patients with septic shock and normal platelet count on the day of diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| septic shock patients | – | Diagnostic Test: platelet responsiveness evaluationInclusion criteria of the study were diagnosis of septic shock and a platelet count >150*103/mcL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in intensive care unit
Key inclusion criteria (2 listed)
- diagnosis of septic shock
- platelet count >150*103/mcL.
Key exclusion criteria (10 listed)
- age <18 years
- history of any hematologic disorder
- chronic liver failure
- previous chemotherapy
- transfusion of platelet during the previous 4 weeks
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 responsiveness evaluationBlood samples were anticoagulated with 0.129 mmol/L of sodium citrate and then centrifugated for 10 min at 200 rpm; platelets aggregation was assessed with an AggRAM Advanced Modular System light transmittance aggregometer (Helena Laboratories, Beaumont, Texas, USA). Low-molecular-weight heparin (LMWH) was given at least 8 hours before any blood aggregation sample. Agonist used to initiate aggregation test were: -Adenosine diphosphate (ADP) to assess P2Y12-dependent platelet aggregation; (20 ng) - Arachidonic acid (AA) to assess cyclooxygenase-dependent platelet Adenosine diphosphate aggregation (1 mcg) - thrombin receptor-activating peptide-6 (TRAP-6) to assess protease-activated receptor 1-dependent platelet aggregation. Max aggregation reached (Aggmax), the slope of the curve (slope) and the latency time (lat) were analyzed for each agonist. | Diagnostic test | septic shock patients |
Primary outcome
Occurence of sepsis-induced thrombocytopenia
Time frame: 5 days after study inclusion
Occurence of platelet count <150 *103/μL
3 secondary outcomes
life-threatening bleeding
Time frame: After 28 days from study inclusion
90-day mortality
Time frame: after 90 days from study enrollment
number of Red blood cells (RBC) packs transfused during ICU stay
Time frame: After 28 days from study inclusion
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 23 Oct 2018.
- Background: PubMed 17161242Campo G, Valgimigli M, Gemmati D, Percoco G, Tognazzo S, Cicchitelli G, Catozzi L, Malagutti P, Anselmi M, Vassanelli C, Scapoli G, Ferrari R. Value of platelet reactivity in predicting response to treatment and clinical outcome in patients undergoing primary coronary intervention: insights into the STRATEGY Study. J Am Coll Cardiol. 2006 Dec 5;48(11):2178-85. doi: 10.1016/j.jacc.2005.12.085. Epub 2006 Nov 13.
- Background: PubMed 29192366Dewitte A, Lepreux S, Villeneuve J, Rigothier C, Combe C, Ouattara A, Ripoche J. Blood platelets and sepsis pathophysiology: A new therapeutic prospect in critically [corrected] ill patients? Ann Intensive Care. 2017 Dec 1;7(1):115. doi: 10.1186/s13613-017-0337-7.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Thrombocytopenia, run by Università degli Studi di Ferrara at 1 site in Italy.
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 10 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 23 Oct 2018. 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 Italy. 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?
Occurence of sepsis-induced thrombocytopenia (time frame: 5 days after study inclusion). 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 NCT03716310, which also lists 2 linked publications.
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 23 Oct 2018.