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

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.

Study Overview

• Status: Unknown
• Conditions: Venous Thromboembolism

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

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Turkey
  • Melikgazi
    • Kayseri, Melikgazi, Turkey
      • Recruiting
      • Erciyes University Faculty of Medicine
      • Contact: Metin Ozkan, Prof; Email: metino@erciyes.edu.tr
      • Principal Investigator: Metin Ozkan, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

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:

• 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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]
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding resolution.	[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 to bleeding in 15 days]

Collaborators and Investigators

• Sponsor: Trio Grup Clinical Research
• Investigators: Principal Investigator: Metin Ozkan, Prof., Erciyes University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: December 5, 2013
• First Submitted That Met QC Criteria: December 16, 2013
• First Posted (Estimate): December 23, 2013

Study Record Updates

• Last Update Posted (Estimate): December 23, 2013
• Last Update Submitted That Met QC Criteria: December 16, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: TREBECA