CClinicalTrials.gg
Status unknownNCT02017743TREBECAUpdated Dec 23, 2013

Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism

An observational study in Venous Thromboembolism, sponsored by Trio Grup Clinical Research. Status unknown at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-23.

Sponsored by Trio Grup Clinical Research · Observational

The sponsor has not verified this record recently (last verified Dec 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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. 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 :
  1. Patients with active bleeding or at-risk for bleeding
  2. Major surgery in the last 7 days
  3. Cardiopulmonary unstability
  4. Severe systemic venous occlusion
  5. Patients at high risk for pulmonary embolism
  6. Thrombocytopenia (\<50000/microliter)
  7. Inpatients under medical or surgery supervision
  8. Patients with low ability to communicate and for whom it is not possible to provide care at home
  9. INR≥1.5 due to liver functions impairment
  10. Diagnosed for cerebral vascular aneurism
  11. Active gastric and/or duodenum ulcer
  12. Diagnosed for bacterial endocarditis
  13. Severe renal function impairment (Creatinine clearance \< 30 ml/min)
  14. Grade 3 hypertension (DBP >= 110 mmHg and/or SBP >= 180 mmHg)
  15. \<35 kg or ≥110 kg weight
  16. Known allergy to heparin and/or its derivatives
  17. History of cerebrovascular event in the last 1 month
  18. Active haemorrhage within the last 3 months
02

Conditions studied

  • Venous Thromboembolism
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's planned enrollment of 200 is below the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

This is the only study on the registry with Trio Grup Clinical Research as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients to enroll will be cancer patients diagnosed for VTE and who are able to receive outpatient LMWH treatment.

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

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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]

  2. 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]

  3. 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]

07

Study locations

1 of 1 sites recruiting
  • Erciyes University Faculty of Medicine
    Kayseri, Melikgazi, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02017743
Lead sponsor
Trio Grup Clinical Research
Responsible party
Sponsor
First posted
Dec 23, 2013
Start date
Dec 2012
Primary completion
Aug 2014 (estimated)
Completion
Aug 2014 (estimated)
Last update
Dec 23, 2013

Study contacts

Metin Ozkan, Prof
Contact
metino@erciyes.edu.tr
Ilker Kurkcu, Pharm
Contact
ilker.kurkcu@triogrup-cro.com
Metin Ozkan, Prof.
principal investigator · Erciyes University Faculty of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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