Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)

Venous Thromboembolism Clinical Trial

— PREDICARE  

Official title:

Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099031
• Other study ID #: NIS-INNOHEP-1093
• Status: Completed
• Start date: May 2015
• Est. completion date: May 15, 2017

Study information

• Verified date: December 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to validate the Ottawa score (risk of thromboembolic recurrences) in cancer patients with thromboembolic disease treated with tinzaparin (Innohep®)

Description:

The Ottawa score is a clinical predictive score aiming at stratifying thromboembolic recurrences in cancer patients according to identified clinical risk factors and histological type of the tumor. This score has never been validated externally in a prospective way in patients treated with tinzaparin. The objective of this observational prospective study is to enroll cancer patients with TED treated with tinzaparin for a planned period of 6 months and to collect data on thromboembolic recurrences, major hemorrhages, deaths and heparin-induced thrombocytopenia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cancer patients with histologically confirmed, active or evolving, solid or liquid tumour, or

• Suspected malignant tumour confirmed within a month of index VTE occurrence

• Treated with specific metastatic or adjuvant anti-cancer treatment

• Patients with recent diagnosis of documented symptomatic or incidental VTE and a prescription of tinzaparin for 6 months

• Proximal or distal VTE of lower limbs

• Pulmonary embolism

• Inferior or superior vena cava thrombosis

• Iliac vein thrombosis

Exclusion Criteria:

• Skin cancer other than melanoma

• Life expectancy less than 6 months

• Superficial isolated thrombosis

• Isolated subsegmental pulmonary embolism

• Cerebral, visceral thrombosis

• Superior limbs VTE or Central catheter thrombosis

• Patients being treated with anticoagulants by more than 7 days

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Tinzaparin
Subcutaneous injection of 175 IU/kg once daily for 6 months

Locations

Country	Name	City	State
France	George Pompidou European Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Premature treatment discontinuation		6 months
Primary	Venous thromboembolism recurrence		6 months
Secondary	Major hemorrhage		6 months
Secondary	Death	All cause mortality	6 months
Secondary	Heparin induced thrombocytopenia		6 months