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

Venous Thromboembolism Clinical Trial

— TREBECA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02017743
• Other study ID #: TREBECA
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2013
• Last updated: December 16, 2013
• Start date: December 2012
• Est. completion date: August 2014

Study information

• Verified date: December 2013
• Source: Trio Grup Clinical Research
• Contact: Metin Ozkan, Prof
• Email: metino[@]erciyes.edu.tr
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Turkey	Erciyes University Faculty of Medicine	Kayseri	Melikgazi

Sponsors (1)

Lead Sponsor	Collaborator
Trio Grup Clinical Research

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding new thrombosis.		[Time to new thrombosis in 15 days]	No
Primary	Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding resolution.		[Time to resolution in 15 days]	No
Primary	Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding bleeding		[Time to bleeding in 15 days]	No