Shock, SurgicalNCT00994877
Thromboelastography in in Patients With Sepsis
An observational study of Shock, Surgical and Systemic Inflammatory Response Syndrome, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Methods: The study is an observational prospective trial that includes 150 patients 18 or older admitted to our icu because of severe sepsis or septic shock as defined by the American College of Chest Physicians/ Society of Critical Care Medicine consensus conference. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shock, Surgical, Systemic Inflammatory Response Syndrome
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to May 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients With sepsis or septic shock admitted to ICU
Who may be able to join
- All patients age 18 years or older admitted to ICU whose primary reason for admission was sepsis or suffering sepsis or septic shock after elective surgical procedure
Who cannot join
- Patients suffering primary disease affecting the coagulation system
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Asaf Harofeh Medical Center
Beer Yaakov
asaf miller, asafmiller@gmail.com
ASAF MILLER, MD
About this study
Official title: Thromboelastography in Patients Admitted to the ICU for Severe Sepsis
Methods:
The study is an observational prospective trial that includes 150 patients 18 or older admitted to our icu because of severe sepsis or septic shock as defined by the American College of Chest Physicians/ Society of Critical Care Medicine consensus conference.
Read more
Patients whose primary reason for hospital admission is sepsis or patients developing sepsis after elective invasive procedure will be included.
Only patients with known former primary coagulation/hypercoagulability disorder wil be excluded.
Procedure:
Within 12 hours of admission to the intensive care unit (ICU) blood will be drawn for the following:
Blood count, glucose, urea, creatinine, liver function tests, prothrombin time, partial thromboplastin time, Ddimer, fibrinogen and TEG (thromboelastography) assay will be performed.
These blood tests will be also drawn on day 2 and 4 of admission. On day one, another 3 cc of blood will be drawn and frozen in -80 degrees for levels of coagulation factors: I, II, V, VII, VIII, IX, X, XI, XII, XIII, Antithrombin III, protein C, S.
Demographic data will be collected according to patient chart, and the acute physiologic and chronic health evaluation (APACHE) II score will be assessed after 24 hours. Vital signs will be collected from monitors.
Informed consent will be waved due to lack of any intervention and the general condition of patients unable to sign an informed consent.
Control group will include 10 healthy individuals.
End point:
The primary end point is to determine the common hypercoagulable/coagulation disorders according to TEG.
The secondary end point is to determine whether TEG results have prognostic implications on this group of severe septic patients.
- Medical subject headings
- Shock, Surgical, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Septic Patients | Not described | |
| Healthy Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the common hypercoagulable/ coagulation disorders according to thromboelastography (TEG)
Measured: In hospital
Secondary outcomes (1)
To determine whether TEG results have prognostic implications on this group of severe septic patients
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
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 Shock, SurgicalStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- asaf miller, md, Principal investigator, Asaf Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994877
- Sponsor's protocol ID
- 34/09
- Status last verified
- Oct 2009
- First submitted
- 24 Sep 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Martini WZ, Cortez DS, Dubick MA, Park MS, Holcomb JB. Thrombelastography is better than PT, aPTT, and activated clotting time in detecting clinically relevant clotting abnormalities after hypothermia, hemorrhagic shock and resuscitation in pigs. J Trauma. 2008 Sep;65(3):535-43. doi: 10.1097/TA.0b013e31818379a6.
PubMed 18784565
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboelastography in Patients Admitted to the ICU for Severe Sepsis
- ClinicalTrials.gov ID
- NCT00994877
- Acronym / sponsor ID
- 34/09
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Mar 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 14 Oct 2009 (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.
Methods:
The study is an observational prospective trial that includes 150 patients 18 or older admitted to our icu because of severe sepsis or septic shock as defined by the American College of Chest Physicians/ Society of Critical Care Medicine consensus conference.
Patients whose primary reason for hospital admission is sepsis or patients developing sepsis after elective invasive procedure will be included.
Only patients with known former primary coagulation/hypercoagulability disorder wil be excluded.
Procedure:
Within 12 hours of admission to the intensive care unit (ICU) blood will be drawn for the following:
Blood count, glucose, urea, creatinine, liver function tests, prothrombin time, partial thromboplastin time, Ddimer, fibrinogen and TEG (thromboelastography) assay will be performed.
These blood tests will be also drawn on day 2 and 4 of admission. On day one, another 3 cc of blood will be drawn and frozen in -80 degrees for levels of coagulation factors: I, II, V, VII, VIII, IX, X, XI, XII, XIII, Antithrombin III, protein C, S.
Demographic data will be collected according to patient chart, and the acute physiologic and chronic health evaluation (APACHE) II score will be assessed after 24 hours. Vital signs will be collected from monitors.
Informed consent will be waved due to lack of any intervention and the general condition of patients unable to sign an informed consent.
Control group will include 10 healthy individuals.
End point:
The primary end point is to determine the common hypercoagulable/coagulation disorders according to TEG.
The secondary end point is to determine whether TEG results have prognostic implications on this group of severe septic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic Patients | – | – |
| Healthy Control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With sepsis or septic shock admitted to ICU
Key inclusion criteria (1 listed)
- All patients age 18 years or older admitted to ICU whose primary reason for admission was sepsis or suffering sepsis or septic shock after elective surgical procedure
Key exclusion criteria (1 listed)
- Patients suffering primary disease affecting the coagulation system
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
To determine the common hypercoagulable/ coagulation disorders according to thromboelastography (TEG)
Time frame: In hospital
1 secondary outcome
To determine whether TEG results have prognostic implications on this group of severe septic patients
Time frame: 28 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
- Background: PubMed 18784565Martini WZ, Cortez DS, Dubick MA, Park MS, Holcomb JB. Thrombelastography is better than PT, aPTT, and activated clotting time in detecting clinically relevant clotting abnormalities after hypothermia, hemorrhagic shock and resuscitation in pigs. J Trauma. 2008 Sep;65(3):535-43. doi: 10.1097/TA.0b013e31818379a6.
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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.
asaf miller, md principal investigator
Asaf Harofeh Medical Center
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 Shock, Surgical and Systemic Inflammatory Response Syndrome, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Oct 2009. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ASAF MILLER, MD (972-577-346002, asafmiller@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the common hypercoagulable/ coagulation disorders according to thromboelastography (TEG) (time frame: In hospital). 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 NCT00994877, 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 14 Oct 2009.