Ignite Creation Date:
2024-05-06 @ 2:19 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02017743
Status:
UNKNOWN
Last Update Posted:
2013-12-23
First Post:
2013-12-05
Brief Title:
Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism
Sponsor:
Trio Grup Clinical Research
Organization:
Trio Grup Clinical Research
Study Overview
Official Title:
Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism - An Observational Study
Status:
UNKNOWN
Status Verified Date:
2013-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREBECA
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 ie patients will be treated according to the best investigators 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
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 50000microliter
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 INR15 due to liver functions impairment
10 Diagnosed for cerebral vascular aneurism
11 Active gastric andor duodenum ulcer
12 Diagnosed for bacterial endocarditis
13 Severe renal function impairment Creatinine clearance 30 mlmin
14 Grade 3 hypertension DBP 110 mmHg andor SBP 180 mmHg
15 35 kg or 110 kg weight
16 Known allergy to heparin andor its derivatives
17 History of cerebrovascular event in the last 1 month
18 Active haemorrhage within the last 3 months
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 50000microliter
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 INR15 due to liver functions impairment
10 Diagnosed for cerebral vascular aneurism
11 Active gastric andor duodenum ulcer
12 Diagnosed for bacterial endocarditis
13 Severe renal function impairment Creatinine clearance 30 mlmin
14 Grade 3 hypertension DBP 110 mmHg andor SBP 180 mmHg
15 35 kg or 110 kg weight
16 Known allergy to heparin andor its derivatives
17 History of cerebrovascular event in the last 1 month
18 Active haemorrhage within the last 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None