Thromboembolic prophylaxis with enoxaparin in non-surgical cancer patients under systemic antineoplastic therapy
| ISRCTN | ISRCTN25616445 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25616445 |
| Protocol serial number | N/A |
| Sponsor | University of Duisburg-Essen (Germany) |
| Funder | Merck & Co., Inc. (USA) |
- Submission date
- 26/11/2007
- Registration date
- 04/04/2008
- Last edited
- 03/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Prof Max E. Scheulen
Scientific
Scientific
University of Duisburg-Essen
Hufelandstr. 55
Essen
45122
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Prospective, randomised, controlled open single-centre trial on thromboembolic prophylaxis with Enoxaparin in non-surgical cancer patients under systemic antineoplastic therapy |
| Study acronym | VTETumor02 |
| Study objectives | Can the use of Clexane® reduce the incidence of thrombosis and pulmonary embolism in cancer patients? As of 20/02/2009 this record was updated to include an extended end date; the initial end date at the time of registration was 31/12/2008. |
| Ethics approval(s) | Ethics committee of the Medical Faculty of the University of Duisburg-Essen gave approval on the 5th September 2007 (ref: 07/3375) |
| Health condition(s) or problem(s) studied | Thrombosis and pulmonary embolism in cancer patients |
| Intervention | Enoxaparin 40 mg subcutaneously daily for 24 weeks versus no therapy (because placebo injections are ethically not justifiable). |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Clexane® (Enoxaparin) |
| Primary outcome measure(s) |
Incidence of thrombosis and/or pulmonary embolism. Duration of follow-up: 24 weeks |
| Key secondary outcome measure(s) |
1. Safety |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 160 |
| Key inclusion criteria | 1. Cancer patients 2. Inpatients 3. Treated with systemic antineoplastic therapy 4. Aged 18 - 85 years, either sex 5. One to three of the following factors given: 5.1. Prior thrombosis in medical history 5.2. Thrombosis in family 5.3. Fever 5.4. Elevated C-reactive protein (CRP) 6. Life expectancy greater than 24 weeks |
| Key exclusion criteria | 1. Pregnancy (positive pregnancy test) or lactating 2. Simultaneous participation in another clinical trial 3. Women of child-bearing age without adequate contraception 4. Known heparin-induced thrombocytopenia (HIT) type II |
| Date of first enrolment | 03/12/2007 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Duisburg-Essen
Essen
45122
Germany
45122
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
