ThrombosisNCT00736008
Thrombophilic Risk Factors in Pediatric Patients Diagnosed at the Ha'Emek Medical Center
An observational study of Thrombosis, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The study will assess the clinical and laboratory data of about 100 pediatric patients diagnosed and treated at the Pediatric Hematology Unit during the years 1980 until 2007 because of thrombotic events. The results, the treatment given, and the outcome of the patients will be summarized. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Thrombosis
- What is being tested?
- Observational
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to Aug 2009
- 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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The population cohort will include about 100 patients diagnosed with thrombotic events at the Pediatric Hematology Unit
Inclusion Criteria:All the patients diagnosed since 1980.
Exclusion Criteria:Patients with insufficient data records.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Hematology Unit - Ha'Emek Medical Center
Afula, Afula, 18101
About this study
Official title: The Study Will Summarize the Clinical and Laboratory Data of All the Pediatric Patients Diagnosed With Thrombotic Events at the Pediatric Hematology Unit
The study will assess the clinical and laboratory data of about 100 pediatric patients diagnosed and treated at the Pediatric Hematology Unit during the years 1980 until 2007 because of thrombotic events.
The results, the treatment given, and the outcome of the patients will be summarized.
- Conditions
- Thrombosis
- Being tested
- Observational
- Keywords
- Factor V Leiden, Prothrombin Mutation, Hypercoagulability, Pediatrics
- Medical subject headings
- Thrombosis, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Data summary only
| Study group | Role | What they receive |
|---|---|---|
| A | Patients with thromboembolic events Receives: Other: Observational |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
- Investigators
- Carina Levin, MD, Principal investigator, Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - IsraelAyala Mari, Student, Principal investigator, Pediatric Dpt B - Ha'Emek Medical Center - Afula - Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736008
- Sponsor's protocol ID
- 0020-08-EMC
- Status last verified
- Aug 2011
- First submitted
- 14 Aug 2008
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study Will Summarize the Clinical and Laboratory Data of All the Pediatric Patients Diagnosed With Thrombotic Events at the Pediatric Hematology Unit
- ClinicalTrials.gov ID
- NCT00736008
- Acronym / sponsor ID
- 0020-08-EMC
- Conditions
- Thrombosis
- Keywords
- Factor V Leiden, Prothrombin Mutation, Hypercoagulability, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 Aug 2008 (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 study will assess the clinical and laboratory data of about 100 pediatric patients diagnosed and treated at the Pediatric Hematology Unit during the years 1980 until 2007 because of thrombotic events.
The results, the treatment given, and the outcome of the patients will be summarized.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: ObservationalPatients with thromboembolic events |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The population cohort will include about 100 patients diagnosed with thrombotic events at the Pediatric Hematology Unit
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 |
|---|---|---|
| ObservationalData summary only | Other | A |
Primary outcome
Not reported in the source record.
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 26 Aug 2011.
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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.
Carina Levin, MD principal investigator
Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel
Ayala Mari, Student principal investigator
Pediatric Dpt B - Ha'Emek Medical Center - Afula - Israel
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 Thrombosis, 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?
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 26 Aug 2011. 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.
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 26 Aug 2011.