Status:
COMPLETED
TIPPS: Thrombophilia in Pregnancy Prophylaxis Study
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Pregnancy
Thrombophilia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 thromboembo...
Detailed Description
TIPPS is a multicentre, multi-national open-label randomized controlled clinical trial. Two hundred and eighty-four thrombophilic women at risk for VTE or placenta mediated pregnancy complications wil...
Eligibility Criteria
Inclusion
- 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
- 1 Protein S
- 2 Protein C
- 3 Antithrombin
- Two positive tests
- 4 Anticardiolipin immunoglobulin M (IgM) (\>30 U/ml)
- 5 Anticardiolipin immunoglobulin G (IgG) (\>30 U/ml)
- 6 Anti-b2 glycoprotein IgG (\>20 U/ml)
- 7 Anti-b2 glycoprotein IgM (\>20 U/ml)
- 8 Lupus anticoagulant
- One positive test
- 9 Factor V Leiden (heterozygous or homozygous)
- 10Prothrombin gene defect (heterozygous or homozygous)
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT00967382
Start Date
July 1 2000
End Date
March 1 2014
Last Update
May 19 2014
Active Locations (12)
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1
Saint Louis University
St Louis, Missouri, United States, 63117
2
University of Utah Health Sciences Centre
Salt Lake City, Utah, United States, 84132
3
Royal Alexandra Hospital
Edmonton, Alberta, Canada
4
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada