TIPPS: Thrombophilia in Pregnancy Prophylaxis Study

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The TIPPS trial seeks to determine the safety and effectiveness of low-molecular-weight heparin (LMWH), an anticoagulant, in preventing placenta mediated pregnancy complications and venous thromboembolism (VTE) in women with thrombophilia. Thus, the principal research question is: can LMWH prevent thrombosis in the leg veins, pulmonary arteries and placental vessels, thereby reducing the risk of deep vein thrombosis, pulmonary embolism (PE), intrauterine growth restriction (IUGR), preeclampsia, miscarriage and stillbirth?

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

One or more of the following:

• Previous preeclampsia

• Previous unexplained intra-uterine growth restriction

• Previous recurrent miscarriage:

• three(3) or more unexplained miscarriage at less than 10 weeks gestation;

• two (2) or more unexplained fetal loss between 10 and 16 weeks gestation;

• one (1) or more unexplained fetal loss at or greater than 16 weeks gestation

• Previous abruptio placenta

• Previous personal history of VTE:

• Previous documented secondary proximal VTE,

• Previous documented calf-vein thrombosis (idiopathic or secondary),

• Previous superficial phlebitis

• First degree relative with symptomatic thrombophilia

• Pregnancy - > 4weeks gestation and < 20 weeks gestation

• Thrombophilia:

• Two abnormal tests, and no normal tests

• 3.1 Protein S

• 3.2 Protein C

• 3.3 Antithrombin

• Two positive tests

• 3.4 Anticardiolipin immunoglobulin M (IgM) (>30 U/ml)

• 3.5 Anticardiolipin immunoglobulin G (IgG) (>30 U/ml)

• 3.6 Anti-b2 glycoprotein IgG (>20 U/ml)

• 3.7 Anti-b2 glycoprotein IgM (>20 U/ml)

• 3.8 Lupus anticoagulant

• One positive test

• 3.9 Factor V Leiden (heterozygous or homozygous)

• 3.10Prothrombin gene defect (heterozygous or homozygous)

Exclusion Criteria:

• Less than 4 weeks gestation or greater than 20 weeks gestation

• No confirmed thrombophilia

• Contraindication to heparin therapy

• History of heparin induced thrombocytopenia

• Platelet count less than 100,000 109/L

• History of osteoporosis or steroid use

• Actively bleeding

• Documented peptic ulcer within 6 weeks

• Heparin, bisulfite or fish allergy

• Severe hypertension (Systolic Blood Pressure >200mmhg and/or Diastolic Blood Pressure >120mmHg)

• Serum creatinine greater than 80 umol/L (1.3mg/dl) and an abnormal 24 hour urine creatine clearance (<30ml/min)

• Severe hepatic failure (INR >1.8)

• Geographic inaccessibility

• Need for anticoagulants, discretion of the investigator such as but not limited to:

• Recurrent fetal loss and phospholipid antibody syndrome

• Prior idiopathic proximal VTE:

• History of idiopathic deep venous thrombosis (DVT) or pulmonary embolism (PE) treated with anticoagulants (> 1 month of heparin or warfarin) or inferior vena cava (IVC) interruption;

• Idiopathic is a VTE occurring outside all of the following periods: antepartum, postpartum, oral contraceptive use, surgery, immobilization, cast, and malignancy

• Mechanical heart valve

• Legal lower age limitations (country specific)

• Prior participation in TIPPS

• Unable/unwilling to provide informed consent