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

NCT02017743 | Unknown

• 1 other identifier: TREBECA
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (3)

• 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]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trio Grup Clinical Research: lead

Study Sites (1)

Erciyes University Faculty of Medicine

Kayseri, Melikgazi, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Metin Ozkan, Prof.

  Erciyes University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Metin Ozkan, Prof

CONTACT

metino@erciyes.edu.tr

Ilker Kurkcu, Pharm

CONTACT

ilker.kurkcu@triogrup-cro.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 23, 2013
• Study Start: December 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

TU (1)