Venous ThromboembolismPREDICARENCT03099031
Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)
An observational study of Venous Thromboembolism, run by LEO Pharma at 1 site in France.
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®) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Tinzaparin
- Type of treatment
- Injection or infusion
- How many people
- 420 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to 15 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient population from French general hospitals, anticancer centres, and university hospitals treating more than 1000 cancer patients per year
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)
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®)
Read the detailed 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
- Conditions
- Venous Thromboembolism
- Being tested
- Tinzaparin
- Keywords
- Ottawa score, tinzaparin, low-molecular weight heparin, anticoagulants, venous thrombosis, thromboembolism, hemostatic disorders, vascular disease, neoplasms, breast neoplasms, lung neoplasms, prostatic neoplasms, colorectal neoplasms, genital neoplasms, urogenital neoplasms, intestinal neoplasms, digestive system neoplasms, lymphoma, leukemia, multiple myeloma
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Thromboembolism, Hemostatic Disorders, Vascular Diseases, Neoplasms, Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TinzaparinDrug
Also called Innohep®
Subcutaneous injection of 175 IU/kg once daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Tinzaparin | Patients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism Receives: Drug: Tinzaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism recurrence
Measured: 6 months
Secondary outcomes (3)
Major hemorrhage
Measured: 6 months
Death
All cause mortality
Measured: 6 months
Heparin induced thrombocytopenia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startMay 2015
- Primary completion15 May 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- G Meyer, Professor, Principal investigator, Service de pneumologie et de soins intensifs, Hôpital Européen Georges Pompidou, ParisF Scotte, Dr, Principal investigator, Unité fonctionnelle de soins oncologiques de support, Hôpital Européen Georges Pompidou, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099031
- Sponsor's protocol ID
- NIS-INNOHEP-1093
- Acronym
- PREDICARE
- Status last verified
- Dec 2019
- First submitted
- 1 Mar 2017
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)
- ClinicalTrials.gov ID
- NCT03099031
- Acronym / sponsor ID
- PREDICARE / NIS-INNOHEP-1093
- Conditions
- Venous Thromboembolism
- Keywords
- Ottawa score, tinzaparin, low-molecular weight heparin, anticoagulants, venous thrombosis, thromboembolism, hemostatic disorders, vascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®)
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tinzaparin | – | Drug: TinzaparinPatients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient population from French general hospitals, anticancer centres, and university hospitals treating more than 1000 cancer patients per year
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- Skin cancer other than melanoma
- Life expectancy less than 6 months
- Superficial isolated thrombosis
- Isolated subsegmental pulmonary embolism
- Cerebral, visceral thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TinzaparinAlso: Innohep®Subcutaneous injection of 175 IU/kg once daily for 6 months | Drug | Tinzaparin |
Primary outcome
Venous thromboembolism recurrence
Time frame: 6 months
3 secondary outcomes
Major hemorrhage
Time frame: 6 months
Death
Time frame: 6 months
Heparin induced thrombocytopenia
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G Meyer, Professor principal investigator
Service de pneumologie et de soins intensifs, Hôpital Européen Georges Pompidou, Paris
F Scotte, Dr principal investigator
Unité fonctionnelle de soins oncologiques de support, Hôpital Européen Georges Pompidou, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by LEO Pharma at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thromboembolism recurrence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.