EUCTR2007-000284-21-GB进行中（未招募）1 期
A multicentre, multinational randomised control trial of prophylactic low molecular weight heparin(LMWH) in high risk pregnant thrombophilic women - Thrombophilia in Pregnancy Prophylaxis Study (TIPPS)
York Hospitals NHS Foundation Trust0 个研究点目标入组 385 人开始时间: 2007年7月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 385
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1 One or more of the following high risk criteria for pregnancy complications (VTE or placenta mediated complications): 1.1 Previous pre-eclampsia. 1.2 Previous unexplained IUGR (Infant birth weight 10th percentile for sex and gestational age). 1.3 Previous recurrent miscarriage defined as: 1.3.1 Three or more unexplained miscarriages under 10 weeks gestation, or 1.3.2 Two or more unexplained foetal losses between 10 and 16 weeks gestation, or 1.3.3 One or more unexplained foetal losses at or greater than 16 weeks gestation. *Examples of explained miscarriage or foetal loss include; loss associated with severe congenital malformations, chromosomal abnormalities, neonatal alloimmune haemolytic anaemia, recent CMV infection, positive foetal or placental Listeria cultures, and women with known abnormal uterine anatomy. 1.4 Women with a history of one or more of the following thromboembolic events: 1.4.2 Previous documented secondary proximal VTE *Secondary includes a VTE that occurs during any of the following periods:surgery, immobilisation, cast, and/or malignancy. Any VTE that occurs outside of these periods is considered idiopathic. Women with idiopathic proximal VTE are ineligible (see section 6.2, exclusion criterion 5.2). ** Proximal VTE includes pulmonary embolism or deep vein thrombosis occurring above the trifurcation of the popliteal vein. 1.4.2 Previous documented primary (idiopathic) calf-vein thrombosis or secondary calf-vein thrombosis. * Calf-vein thrombosis is a DVT that occurs below the trifurcation of the popliteal vein. 1.4.3 Previous superficial phlebitis * Superficial phlebitis (also known as thrombophlebitis) refers to thrombosis in a superficial vein. 1.5 Previous major abruptio placenta, defined as an abruption associated with: vaginal bleeding or concealed hemorrhage, and uterine tenderness, and foetal distress, maternal shock, or maternal coagulopathy 1.6 A first degree relative (FDR) with symptomatic thrombophilia (a history of PE or DVT treated with anticoagulants (over one month with heparin or warfarin)). 2. Pregnancy confirmed by a positive serum or urine ßHcG. 3. Thrombophilia confirmed by one or more thrombophilia: Two abnormal tests, and no normal tests, for one or more of the following: 3.1 Protein C deficiency 3.2 Protein S deficiency (outside the normal range for gestational age, see Appendix V), so long as: At least one test is done outside pregnancy or the 6 week post partum period, or In addition to the two abnormal tests in pregnancy, one abnormal test (and no normal tests) is obtained in a first degree relative (FDR). 3.3 Antithrombin deficiency OR Two positive tests for one or more of the following: 3.4 Anticardiolipin IgG (>30 U/ml) 3.5 Anticardiolipin IgM (>30 U/ml) 3.6 Anti-ß2 glycoprotein IgG (>20 U/ml) 3.7 Anti-ß2 glycoprotein IgM (>20 U/ml) 3.8 Lupus anticoagulant OR One positive test for: 3.9 Factor V Leiden One positive PCR result for Factor V Leiden, or Documented activated protein C resistance and a FDR testing once for Factor V Leiden (PCR positive) 3.10 Prothrombin gene defect 4. Signed Informed Consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Less than 4weeks +1 day and greater than 19 weeks +6 days gestational age at time of randomisation. 2. Contraindication to heparin therapy including 2.1 History of heparin induced thrombocytopenia 2.2 Platelet count of less than 100,000 x 106/L 2.3 History of osteoporosis or steroid use (potential increased risk of osteoporosis and osteoporotic fracture with heparin therapy) 2.4 Actively bleeding 2.5 Documented peptic ulcer within 6 weeks (contraindication to anticoagulation) 2.6 Heparin, bisulfite or fish allergy 2.7 Severe hypertension (SBP>200 and/or DBP>120 - contraindication to anticoagulation) 2.8 Severe hepatic failure (INR>1.8) (increased likelihood of bleeding) 3. Women with serum creatinines greater than 80 and an abnormal 24 hour creatinine clearance. * Women with serum creatinines less than 80 do not require a normal 24hr creatinine clearance to be eligible. 4. Geographic inaccessibility (less likely to comply with required follow-up visits and care). 5. Need for anticoagulants as judged by the local investigator such as but not limited to: 5.1 Women with recurrent foetal loss with antiphospholipid antibody syndrome 5.2 Women with prior idiopathic proximal VTE * History of PE or DVT treated with anticoagulants (over one month of heparin or warfarin) or IVC interruption * Idiopathic refers to a VTE that occurs outside all of the following periods: antepartum, postpartum, oral contraceptive use, surgery, immobilisation, cast, and/or malignancy. * Proximal refers to a VTE that occurs above the bifurcation of the popliteal vein. 5.4 Women with mechanical heart valves 6. Women <18 years of age 7. Prior participation in TIPPS 8. Women unable/unwilling to providing informed consent. Subjects currently receiving ASA 80mg daily are eligible for the study
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