A comparison of enoxaparin and tinzaparin as thromboprophylaxis during pregnancy
| ISRCTN | ISRCTN65511274 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65511274 |
| Protocol serial number | N0436130319 |
| Sponsor | Department of Health |
| Funders | Leeds Teaching Hospitals NHS Trust, NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 16/03/2016
- 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
Dr S L Monte
Scientific
Scientific
Department of Obstetric Anaesthesia
Leeds Teaching Hospitals NHS Trust
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 243 3144 |
|---|---|
| r&d@leedsth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A comparison of enoxaparin and tinzaparin as thromboprophylaxis during pregnancy |
| Study objectives | Unpublished data prepared by our department has shown that pregnant women display some resistance to the use of low molecular weight heparins. We would like to compare the use of enoxaparin and tinzaparin in pregnant women who have a previous history of venous thromboembolism, or who have inherited of acquired condition which predisposes them to venous thromboprophylactic doses as recommended by the respective manufacturers and monitoring the effects by using anti factor Xa assays and thromboelastography. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Thromboembolism |
| Intervention | Randomised controlled trial. Random allocation to receive: 1. Enoxaparin 2. Tinaparin |
| Intervention type | Other |
| Primary outcome measure(s) |
We propose to compare the coagulation profiles of enoxaparin and tinaparin. We will use TEG and anti Xa activity to monitor effects. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Pregnant patients with moderate risks of venous thromboembolism 2. Patients with history of recurrent miscarriage 3. Patients on low dose aspirin will be included as this has been shown not to adversely affect their TEG variables |
| Key exclusion criteria | 1. Subjects who have been admitted to hospital and are able to maintain their self catheterization regime 2. Subjects with symptomatic urinary tract infection, who are currently undergoing chemotherapy, radiation or steroid therapy, who self catheterize only once a day |
| Date of first enrolment | 01/08/2001 |
| Date of final enrolment | 01/08/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds Teaching Hospitals NHS Trust
Department of Obstetric Anaesthesia
Leeds
LS9 7TF
United Kingdom
Leeds
LS9 7TF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
16/03/2016: No publications found, verifying study status with principal investigator
