NOSTRADAMUS: testing for thrombophilia in patients with a first episode of venous thromboembolism: a randomised controlled trial to assess effects on clinical outcomes, quality of life, and costs
| ISRCTN | ISRCTN07836779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07836779 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 06/01/2021
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S Middeldorp
Scientific
Scientific
Academic Medical Center (AMC)
Department of Vascular Medicine, F4-276
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 5976 |
|---|---|
| s.middeldorp@lumc.nl |
Study information
| Study design | Randomised, controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | NOSTRADAMUS: testing for thrombophilia in patients with a first episode of venous thromboembolism: a randomised controlled trial to assess effects on clinical outcomes, quality of life, and costs |
| Study acronym | NOSTRADAMUS |
| Study objectives | Testing for thrombophilia after a first episode of Venous ThromboEmbolism (VTE) with subsequent prolongation of anticoagulant treatment in thrombophilic patients is beneficial in terms of clinical outcomes, quality of life, and costs. |
| Ethics approval(s) | Approval received from the Medical Ethics Board of the Acamdemic Medical Center Amsterdam on September 20th 2006 (ref: MEC 06/216). |
| Health condition(s) or problem(s) studied | Pulmonary embolism, deep vein thrombosis |
| Intervention | Randomisation between disclosure and undisclosure of results of thrombophilia screening and subsequent additional anticoagulant treatment for a predefined period will be installed in those in whom thrombophilia is detected in the disclosure group. |
| Intervention type | Other |
| Primary outcome measure | Recurrent VTE 18 months after the acute episode of VTE. |
| Secondary outcome measures | 1. Recurrent VTE at the end of the study 2. A composite endpoint of recurrent VTE and bleeding at the end of the study 3. Quality of life 4. Costs of testing and subsequent predefined prolongation of anticoagulant therapy |
| Overall study start date | 01/10/2006 |
| Completion date | 01/04/2010 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 1336 |
| Key inclusion criteria | 1. Subjects must be willing and able to give written informed consent 2. Confirmed symptomatic Deep Vein Thrombosis (DVT), i.e., proximal vein or extensive calf-vein thrombosis, involving at least the upper third part of the deep calf veins (trifurcation, and/or confirmed symptomatic Pulmonary Embolism (PE), no longer than two months prior to randomisation 3. Aged 18 years or older |
| Key exclusion criteria | 1. Previous episodes of DVT or PE 2. Active bleeding or high risk for bleeding contraindicating treatment with Low Molecular Weight Heparin (LMWH), fondaparinux or Vitamin K Antagonists (VKA) 3. Insertion of a caval filter to treat the episode of VTE 4. Active cancer or anti-cancer treatment in the six months prior to the acute episode of VTE 5. Life expectancy less than 18 months 6. Arterial thrombotic events in the context of a confirmed antiphospholipid antibody syndrome 7. Indications for VKA other than DVT |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 01/04/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Center
Hospital/treatment centre
Hospital/treatment centre
Department of Vascular Medicine
PO Box 22660
Amsterdam
1100 DD
Netherlands
| Website | https://www.amc.nl/web/Zorg.htm |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Research organisation
Netherlands Heart Foundation (NHS, Nederlandse Hartstichting) (The Netherlands)
No information available
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | early termination | 20/09/2008 | 06/01/2021 | Yes | No |
Editorial Notes
06/01/2021: The trial was stopped due to low inclusion rates. Publication reference added.
