Venous ThromboembolismNCT01744431
Can Thrombin Generation Measurement Predict the Risk of Venous Thromboembolism in Acute Ill Patients
An observational study of Venous Thromboembolism, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Can thrombin generation measurement predict the risk of venous thromboembolism in acute ill patients Traditional coagulation tests do not assess the whole coagulation system. Thrombin generation assays measure the ability of plasma sample to generate thrombin following in vitro activation of coagulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Sep 2013
- How long will I take part?
- 1 Day
- 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: 300 hospitalized patients
Who may be able to join
- signed inform consent
Who cannot join
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Can thrombin generation measurement predict the risk of venous thromboembolism in acute ill patients
Traditional coagulation tests do not assess the whole coagulation system. Thrombin generation assays measure the ability of plasma sample to generate thrombin following in vitro activation of coagulation. In contrast to the classical clotting assays, thrombin generation reflects and integrates all pro and anticoagulant reactions that regulate the formation and inhibition of thrombin.
Read more
The aim of our study is to investigate whether thrombin generation would be able to predict a hypercoagulable state in acute ill patients admitted in the internal medical departments and how it correlates with the Padua prediction score, a score that could assists the risk for venous thromboembolism in hospitalized medical patients.
In total 300 patients are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. We will measure the thrombin generation over time in plasma assessed by the calibrated automated thrombogram (CAT).
- Conditions
- Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
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 |
|---|---|---|
| No treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
venous thromboembolism
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elias mazen, HaEmek Medical Center, Israel
- Investigators
- mazen elias, MD, Principal investigator, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744431
- Sponsor's protocol ID
- thrombin generation
- Status last verified
- Dec 2015
- First submitted
- 5 Dec 2012
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Thrombin Generation Measurement Predict the Risk of Venous Thromboembolism in Acute Ill Patients
- ClinicalTrials.gov ID
- NCT01744431
- Acronym / sponsor ID
- thrombin generation
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Dec 2012 (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.
Can thrombin generation measurement predict the risk of venous thromboembolism in acute ill patients
Traditional coagulation tests do not assess the whole coagulation system. Thrombin generation assays measure the ability of plasma sample to generate thrombin following in vitro activation of coagulation. In contrast to the classical clotting assays, thrombin generation reflects and integrates all pro and anticoagulant reactions that regulate the formation and inhibition of thrombin.
The aim of our study is to investigate whether thrombin generation would be able to predict a hypercoagulable state in acute ill patients admitted in the internal medical departments and how it correlates with the Padua prediction score, a score that could assists the risk for venous thromboembolism in hospitalized medical patients.
In total 300 patients are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. We will measure the thrombin generation over time in plasma assessed by the calibrated automated thrombogram (CAT).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 hospitalized patients
Key inclusion criteria (1 listed)
- signed inform consent
Key exclusion criteria (1 listed)
- pregnant women
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
venous thromboembolism
Time frame: 1 week
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 16 Dec 2015.
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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.
mazen elias, MD principal investigator
Emek 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 Venous Thromboembolism, run by HaEmek Medical Center, Israel 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: finished, as of the sponsor's last update on 16 Dec 2015. 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?
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?
venous thromboembolism (time frame: 1 week). 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 16 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.