Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)
PREDICARE
Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)
1 other identifier
observational
420
1 country
1
Brief 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®)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 1, 2017
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2017
CompletedDecember 16, 2019
December 1, 2019
2 years
March 1, 2017
December 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Venous thromboembolism recurrence
6 months
Secondary Outcomes (3)
Major hemorrhage
6 months
Death
6 months
Heparin induced thrombocytopenia
6 months
Other Outcomes (1)
Premature treatment discontinuation
6 months
Study Arms (1)
Tinzaparin
Patients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism
Interventions
Subcutaneous injection of 175 IU/kg once daily for 6 months
Eligibility Criteria
Patient population from French general hospitals, anticancer centres, and university hospitals treating more than 1000 cancer patients per year
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (1)
George Pompidou European Hospital
Paris, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
G Meyer, Professor
Service de pneumologie et de soins intensifs, Hôpital Européen Georges Pompidou, Paris
- PRINCIPAL INVESTIGATOR
F Scotte, Dr
Unité fonctionnelle de soins oncologiques de support, Hôpital Européen Georges Pompidou, Paris
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2017
First Posted
April 4, 2017
Study Start
May 1, 2015
Primary Completion
May 15, 2017
Study Completion
May 15, 2017
Last Updated
December 16, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share