Bariatric Patients Undergoing Bariatric SurgeryNCT01819207
Evaluation of the Coagulation Profile by Thromboelastography in Bariatric Patients
A study testing blood test by thromboelastography in people with Bariatric Patients Undergoing Bariatric Surgery, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
thromboelastography can identify alteration in the coagulation profile in bariatric patients who undergo sleeve gastrectomy or gastric bypass Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Patients Undergoing Bariatric Surgery
- What is being tested?
- blood test by thromboelastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Apr 2015
- 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
- patients undergoing bariatric surgery
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
thromboelastography can identify alteration in the coagulation profile in bariatric patients who undergo sleeve gastrectomy or gastric bypass
- Being tested
- blood test by thromboelastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood test by thromboelastographyOther
| Study group | Role | What they receive |
|---|---|---|
| TEG group | Experimental | Not described Receives: Other: blood test by thromboelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
coagulation profile by thromboelastography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2015
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 Bariatric Patients Undergoing Bariatric SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819207
- Sponsor's protocol ID
- 1492MF
- Status last verified
- Mar 2013
- First submitted
- 24 Mar 2013
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Munro TG. Glass is detectable on plain radiographs. CMAJ. 1989 Feb 15;140(4):365. No abstract available.
PubMed 2914257
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Coagulation Profile by Thromboelastography in Bariatric Patients
- ClinicalTrials.gov ID
- NCT01819207
- Acronym / sponsor ID
- 1492MF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Mar 2013 (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.
thromboelastography can identify alteration in the coagulation profile in bariatric patients who undergo sleeve gastrectomy or gastric bypass
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEG group | Experimental | Other: blood test by thromboelastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing bariatric surgery
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| blood test by thromboelastography | Other | TEG group |
Primary outcome
coagulation profile by thromboelastography
Time frame: 1 year
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 1 Jun 2016.
- Background: PubMed 2914257Munro TG. Glass is detectable on plain radiographs. CMAJ. 1989 Feb 15;140(4):365. No abstract available.
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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?
A study testing blood test by thromboelastography in people with Bariatric Patients Undergoing Bariatric Surgery, run by Western Galilee Hospital-Nahariya 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 1 Jun 2016. 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?
coagulation profile by thromboelastography (time frame: 1 year). 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 NCT01819207, 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 1 Jun 2016.