Venous ThromboembolismTREBECANCT02017743
Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism
An observational study of Venous Thromboembolism, run by Trio Grup Clinical Research at 1 site in Turkey (Türkiye).
Trial summary
This study is a multicenter post authorization observational study. Cancer patients diagnosed with non high risk VTE and are followed up in an outpatient setting will be treated with LMWH and the data will be recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2012to Aug 2014
- 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: Patients to enroll will be cancer patients diagnosed for VTE and who are able to receive outpatient LMWH treatment.
Who may be able to join
- 18 years or upper age
- A signed informed consent document
- Cancer patient diagnosed for VTE
- Life expectancy > 6 months
- Eligible for criteria of outpatient administration of LMWH
Who cannot join
- Patients with active bleeding or at-risk for bleeding
- Major surgery in the last 7 days
- Cardiopulmonary unstability
- Severe systemic venous occlusion
- Patients at high risk for pulmonary embolism
- Thrombocytopenia (<50000/microliter)
Show all 18Show fewer
- Inpatients under medical or surgery supervision
- Patients with low ability to communicate and for whom it is not possible to provide care at home
- INR≥1.5 due to liver functions impairment
- Diagnosed for cerebral vascular aneurism
- Active gastric and/or duodenum ulcer
- Diagnosed for bacterial endocarditis
- Severe renal function impairment (Creatinine clearance < 30 ml/min)
- Grade 3 hypertension (DBP >= 110 mmHg and/or SBP >= 180 mmHg)
- <35 kg or ≥110 kg weight
- Known allergy to heparin and/or its derivatives
- History of cerebrovascular event in the last 1 month
- Active haemorrhage within the last 3 months
Trial locations and contacts
1 site in 1 country.
Metin Ozkan, Prof contact
Ilker Kurkcu, Pharm contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University Faculty of Medicine
Kayseri, Melikgazi
Metin Ozkan, Prof, metino@erciyes.edu.tr
Metin Ozkan, Prof
About this study
Official title: Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism - An Observational Study
This study is a multicenter post authorization observational study. Cancer patients diagnosed with non high risk VTE and are followed up in an outpatient setting will be treated with LMWH and the data will be recorded. Since this is an observational study there are no specific treatment protocols, i.e., patients will be treated according to the best investigator's criteria. Treatment protocol will be based on the routine treatment practice of the involved investigator. Patients to enroll will be cancer patients diagnosed for VTE and who are able to receive outpatient LMWH treatment. There will be no specific hypothesis to be tested.
Read the detailed description
Inclusion criteria
- 18 years or upper age
- A signed informed consent document
- Cancer patient diagnosed for VTE
- Life expectancy > 6 months
- Eligible for criteria of outpatient administration of LMWH
Exclusion criteria
- Should not carry any medical situation listed below, that outpatient administration of LMWH might be risky :
- Patients with active bleeding or at-risk for bleeding
- Major surgery in the last 7 days
- Cardiopulmonary unstability
- Severe systemic venous occlusion
- Patients at high risk for pulmonary embolism
- Thrombocytopenia (<50000/microliter)
- Inpatients under medical or surgery supervision
- Patients with low ability to communicate and for whom it is not possible to provide care at home
- INR≥1.5 due to liver functions impairment
- Diagnosed for cerebral vascular aneurism
- Active gastric and/or duodenum ulcer
- Diagnosed for bacterial endocarditis
- Severe renal function impairment (Creatinine clearance < 30 ml/min)
- Grade 3 hypertension (DBP >= 110 mmHg and/or SBP >= 180 mmHg)
- <35 kg or ≥110 kg weight
- Known allergy to heparin and/or its derivatives
- History of cerebrovascular event in the last 1 month
- Active haemorrhage within the last 3 months
- Conditions
- Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding new thrombosis.
Measured: [Time to new thrombosis in 15 days]
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding resolution.
Measured: [Time to resolution in 15 days]
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding bleeding
Measured: [Time to bleeding in 15 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trio Grup Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Metin Ozkan, Prof., Principal investigator, Erciyes University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017743
- Sponsor's protocol ID
- TREBECA
- Acronym
- TREBECA
- Status last verified
- Dec 2013
- First submitted
- 5 Dec 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism - An Observational Study
- ClinicalTrials.gov ID
- NCT02017743
- Acronym / sponsor ID
- TREBECA / TREBECA
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Trio Grup Clinical ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 23 Dec 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.
This study is a multicenter post authorization observational study. Cancer patients diagnosed with non high risk VTE and are followed up in an outpatient setting will be treated with LMWH and the data will be recorded. Since this is an observational study there are no specific treatment protocols, i.e., patients will be treated according to the best investigator's criteria. Treatment protocol will be based on the routine treatment practice of the involved investigator. Patients to enroll will be cancer patients diagnosed for VTE and who are able to receive outpatient LMWH treatment. There will be no specific hypothesis to be tested.
Detailed description
Inclusion criteria
- 18 years or upper age
- A signed informed consent document
- Cancer patient diagnosed for VTE
- Life expectancy > 6 months
- Eligible for criteria of outpatient administration of LMWH
Exclusion criteria
- Should not carry any medical situation listed below, that outpatient administration of LMWH might be risky :
- Patients with active bleeding or at-risk for bleeding
- Major surgery in the last 7 days
- Cardiopulmonary unstability
- Severe systemic venous occlusion
- Patients at high risk for pulmonary embolism
- Thrombocytopenia (<50000/microliter)
- Inpatients under medical or surgery supervision
- Patients with low ability to communicate and for whom it is not possible to provide care at home
- INR≥1.5 due to liver functions impairment
- Diagnosed for cerebral vascular aneurism
- Active gastric and/or duodenum ulcer
- Diagnosed for bacterial endocarditis
- Severe renal function impairment (Creatinine clearance < 30 ml/min)
- Grade 3 hypertension (DBP >= 110 mmHg and/or SBP >= 180 mmHg)
- <35 kg or ≥110 kg weight
- Known allergy to heparin and/or its derivatives
- History of cerebrovascular event in the last 1 month
- Active haemorrhage within the last 3 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients to enroll will be cancer patients diagnosed for VTE and who are able to receive outpatient LMWH treatment.
Key inclusion criteria (5 listed)
- 18 years or upper age
- A signed informed consent document
- Cancer patient diagnosed for VTE
- Life expectancy > 6 months
- Eligible for criteria of outpatient administration of LMWH
Key exclusion criteria (18 listed)
- Patients with active bleeding or at-risk for bleeding
- Major surgery in the last 7 days
- Cardiopulmonary unstability
- Severe systemic venous occlusion
- Patients at high risk for pulmonary embolism
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
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding new thrombosis.
Time frame: [Time to new thrombosis in 15 days]
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding resolution.
Time frame: [Time to resolution in 15 days]
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding bleeding
Time frame: [Time to bleeding in 15 days]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
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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.
Metin Ozkan, Prof contact
Ilker Kurkcu, Pharm contact
Metin Ozkan, Prof. principal investigator
Erciyes University Faculty of Medicine
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 Trio Grup Clinical Research at 1 site in Turkey (Türkiye).
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 5 inclusion and 18 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 23 Dec 2013. 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 Turkey (Türkiye). 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 Metin Ozkan, Prof (metino@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding new thrombosis. (time frame: [Time to new thrombosis in 15 days]). The study lists 3 primary outcomes in all. 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 23 Dec 2013.