ThrombelastographyNCT02971111
Thromboelastometry in Assessment of Sepsis Coagulopathy
An observational study of Thrombelastography and Sepsis, run by University Hospital, Motol.
Trial summary
The purpose of this study is to analyze occurence of bleeding complications during invasive procedures in septic patients with normal tromboelastometry results despite prolonged standard coagulation tests results Read more about this study
- Who is it for?
- Ages 24 to 89 years
- Conditions the study is for
- Thrombelastography, Sepsis
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Oct 2016
- 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 24 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients with sepsis who underwent invasive procedures
Who may be able to join
- sepsis/septic shock
- prolonged PT-INR (international normalized ratio) ≥ 1.3
- normal ROTEM-EXTEM results.
Who cannot join
- patients on antiplatelet drugs or anticoagulant therapy (heparin, vitamin K antagonists…)
- patients with cirrhosis
About this study
Official title: Evaluation of Thromboelastometry in Sepsis in Correlation to Bleeding During Invasive Procedures
The purpose of this study is to analyze occurence of bleeding complications during invasive procedures in septic patients with normal tromboelastometry results despite prolonged standard coagulation tests results
- Conditions
- Thrombelastography, Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of bleeding complications
In our group of 76 septic patients who had normal values of EXTEM despite prolonged INR/PR invasive procedures were performed without severe bleeding.
Measured: 2013 - 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startJan 2013
- Primary completionOct 2016
- Study completionOct 2016
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 ThrombelastographyStudies 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
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic
- Responsible party
- Principal investigator, Durila Miroslav MUDr. Ph.D., University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971111
- Sponsor's protocol ID
- 1318514
- Status last verified
- Sep 2018
- First submitted
- 19 Nov 2016
- Last updated
- 10 Sep 2018
- Results posted
- No
Publications
Lukas P, Durila M, Jonas J, Vymazal T. Evaluation of Thromboelastometry in Sepsis in Correlation With Bleeding During Invasive Procedures. Clin Appl Thromb Hemost. 2018 Sep;24(6):993-997. doi: 10.1177/1076029617731624. Epub 2017 Sep 26.
PubMed 28950719
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thromboelastometry in Sepsis in Correlation to Bleeding During Invasive Procedures
- ClinicalTrials.gov ID
- NCT02971111
- Acronym / sponsor ID
- 1318514
- Conditions
- Thrombelastography, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic
- Study start
- Jan 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Nov 2016 (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.
The purpose of this study is to analyze occurence of bleeding complications during invasive procedures in septic patients with normal tromboelastometry results despite prolonged standard coagulation tests results
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 24 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients with sepsis who underwent invasive procedures
Key inclusion criteria (3 listed)
- sepsis/septic shock
- prolonged PT-INR (international normalized ratio) ≥ 1.3
- normal ROTEM-EXTEM results.
Key exclusion criteria (2 listed)
- patients on antiplatelet drugs or anticoagulant therapy (heparin, vitamin K antagonists…)
- patients with cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of bleeding complications
Time frame: 2013 - 2016
In our group of 76 septic patients who had normal values of EXTEM despite prolonged INR/PR invasive procedures were performed without severe bleeding.
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 Sep 2018.
- Derived from this study: PubMed 28950719Lukas P, Durila M, Jonas J, Vymazal T. Evaluation of Thromboelastometry in Sepsis in Correlation With Bleeding During Invasive Procedures. Clin Appl Thromb Hemost. 2018 Sep;24(6):993-997. doi: 10.1177/1076029617731624. Epub 2017 Sep 26.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombelastography and Sepsis, run by University Hospital, Motol.
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 3 inclusion and 2 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 Sep 2018. 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 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?
incidence of bleeding complications (time frame: 2013 - 2016). 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 NCT02971111, 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 Sep 2018.