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TIPPS: Thrombophilia in Pregnancy Prophylaxis Study
This study is currently recruiting participants.
Verified July 2011 by Ottawa Hospital Research Institute

First Received on May 29, 2009.   Last Updated on July 19, 2011   History of Changes
Sponsor: Ottawa Hospital Research Institute
Collaborator: Canadian Institutes of Health Research (CIHR)
Information provided by: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00967382
  Purpose

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, intrauterine growth restriction (IUGR), preeclampsia, miscarriage and stillbirth?


Condition Intervention Phase
Pregnancy
Thrombophilia
Pregnancy Complications
Drug: dalteparin sodium 5,000 IU prefilled syringes (antenatal)
Drug: dalteparin sodium (after delivery - Control group)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TIPPS - Thrombophilia in Pregnancy Prophylaxis Study: A Multicentre, Multinational, Randomized Control Trial of Prophylaxis Low Molecular Weight Heparin (LMWH) in High-risk Thrombophilic Women.

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • The primary objective of the study is to identify if LMWH prophylaxis in thrombophilic pregnant women results in a greater than 33% relative risk reduction in the composite outcome measure (VTE, pre-eclampsia, IUGR and fetal loss) [ Time Frame: 6 weeks post-partum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify if prophylactic LMWH will reduce rates of PIH, preterm labor and abruptio placenta in pregnant thrombophilic women compared to control [ Time Frame: 6 weeks post-partum ] [ Designated as safety issue: No ]
  • Determine the safety of LWH use in pregnancy (Specifically rates of bleeding, thrombocytopenia and fractures) [ Time Frame: 6 weeks post-partum ] [ Designated as safety issue: Yes ]
  • Identify whether prolonged use of LMWH in pregnancy results in decreased BMD compared to control [ Time Frame: 6 weeks post-partum ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 385
Study Start Date: July 2000
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Drug: dalteparin sodium (after delivery - Control group)

Subject's randomized to the control group will receive identical obstetrical care and follow-up, but no antenatal dalteparin

Within 24 hours of delivery, subject's will start dalteparin sodium 5,000 IU s.c. daily for 6 weeks

Active Comparator: dalteparin sodium Drug: dalteparin sodium 5,000 IU prefilled syringes (antenatal)

Subject's randomize to treatment arm will receive dalteparin sodium 5,000 IU s.c. daily starting on randomization day until 20 weeks gestational age then;

dalteparin sodium 5,000 IU s.c. bid from 20 weeks to onset of labour or 37 weeks gestation (discontinued at the discretion of the investigator/obstetrician)

Within 24 hours of delivery, subject's will restart dalteparin sodium 5,000 IU s.c. daily for 6 weeks

Other Name: Fragmin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:One or more of the following

  • Previous preeclampsia
  • Previous unexplained intra-uterine growth restriction
  • Previous recurrent miscarriage:

    • 3 or more unexplained miscarriage at less than 10 weeks gestation
    • 2 or more unexplained fetal loss between 10 and 16 weeks gestation
    • 1 or more unexplained fetal loss at or greater than 16 weeks gestation
  • Previous abruptio placenta
  • Women with one or more of the following thrombotic events:

    • 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
  • Protein S
  • Protein C
  • Antithrombin
  • Two positive tests
  • Anticardiolipin IgM (>30 U/ml)
  • Anticardiolipin IgG (>30 U/ml)
  • Anti-b2 glycoprotein IgG (>20 U/ml)
  • Anti-b2 glycoprotein IgM (>20 U/ml)
  • Lupus anticoagulant
  • One positive test
  • Factor V Leiden (heterozygous or homozygous)
  • Prothrombin gene defect (heterozygous or homozygous)

Exclusion Criteria:

  • Less than 4 weeks gestation
  • Greater than 19+6 weeks gestation
  • 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 (SBP >200mmhg and/or DBP >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 DVT or PE treated with anticoagulants (> 1 month of heparin or warfarin) or IVC interruption;
      • Idiopathic is a VTE occurring outside all of the following periods: antepartum, postpartum, oral contraceptive use, surgery, immobilaztion, cast, and malignancy
    • Mechanical heart valve
  • Legal lower age limitations (country specific)
  • Prior participation in TIPPS
  • Unable/unwilling to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967382

Contacts
Contact: Marc A Rodger, MD 613-737-8899 ext 74641 mrodger@ohri.ca
Contact: Anne Marie Y Clement, RN 613-798-5555 ext 19841 amclement@ohri.ca

Locations
United States, Missouri
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63117
Contact: Raul Artal, MD     314-781-4772 ext 2     artalr@slu.edu    
Contact: Suzanne Hampton     314-977-2088     shampt10@slu.edu    
Principal Investigator: Raul Artal, MD            
United States, Utah
University of Utah Health Sciences Centre Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Robert M Silver, MD     801-585-5156     bsilver@hsc.utah.edu    
Contact: Carla Hickenlooper     801-581-6196     Carla.Hickenlooper@hsc.utah.edu    
Principal Investigator: Robert M Silver, MD            
Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Rshmi Khurana, MD     780-491-6827     RKhurana@cha.ab.ca    
Contact: Cheryl Lux     780-491-6827     Cheryl.lux@albertahealthservices.ca    
Principal Investigator: Rshmi Khurana, MD            
Canada, Nova Scotia
QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada
Contact: K. Sue Robinsons, MD     902-473-3779     Sue.Robinson@cdha.nshealth.ca    
Contact: Rebecca Wood     902-473-7454     rebekah.wood@cdha.nshealth.ca    
Principal Investigator: K. Sue Robinson, MD            
Sub-Investigator: David Anderson, MD            
Canada, Ontario
Hamilton Health Sciences Centre Recruiting
Hamilton, Ontario, Canada
Contact: Sarah McDonald, MD     905-525-9140 ext 26559     mcdonals@mcmaster.ca    
Principal Investigator: Sarah McDonald, MD            
The Ottawa Hospital, Civic Campus Recruiting
Ottawa, Ontario, Canada
Contact: Marc Rodger, MD     613-737-8899 ext 14641     mrodger@ohri.ca@ohri.ca    
Contact: Daphne Towers     613-798-5555 ext 14113     dtowers@ohri.ca    
Principal Investigator: Philip Wells, MD            
Sub-Investigator: Melissa Forgie, MD            
Sub-Investigator: Dimitri Scarvelis, MD            
Sub-Investigator: Catherine Code, MD            
Sub-Investigator: Alan Karovitch, MD            
Sub-Investigator: Carol Gonsalves, MD            
Sub-Investigator: Marc Carrier, MD            
Women's College Health Sciences Centre Recruiting
Toronto, Ontario, Canada
Contact: Wee Shian Chan, MD     416-323-6272     wee-shian.chan@swchsc.on.ca    
Contact: Myrieal Quilacio     416-323-7036     Myriel.Quilacio@swchsc.on.ca    
Principal Investigator: Wee Shian Chan, MD            
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada
Contact: John Kingdom, MD     416-586-8764     jkingdom@mtsinai.on.ca    
Contact: Kathy Leliever     416-586-4800 ext 2940     kleliever@hotmail.com    
Principal Investigator: John Kingdom, MD            
Sub-Investigator: Matthew Sermer, MD            
Canada, Quebec
SMBD Jewish General Hospital Recruiting
Montreal, Quebec, Canada
Contact: Susan Kahn, MD     514-340-8222 ext 4667     susan.kahn@mcgill.ca    
Contact: Carla Strulovitch     514-340-8222 ext 4817     cstrulovitch@med.jgh.mcgill.ca    
Principal Investigator: Susan Kahn, MD            
Sub-Investigator: Mark Blostein, MD            
St Mary's Hospital Centre Recruiting
Montreal, Quebec, Canada
Contact: Susan Solymoss, MD     514-734-2607     solymossS@muhchem.mcgill.ca    
Contact: Katia Mendelew         kathia.mendelew@ssss.gouv.qc.ca    
Principal Investigator: Susan Solymoss, MD            
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada
Contact: Jill Newstead-Angel, MD     306-966-1943     jill.newstead@shaw.ca    
Contact: Corinne Riley     306-653-5970     rileycrc@shaw.ca    
Principal Investigator: Jill Newstead-Angel, MD            
Sub-Investigator: Jocelyne Martel, MD            
Canada
CHA, Hopital Enfant Jesus Recruiting
Quebec, Canada
Contact: Christine Demers, MD     418-649-5726     dspdemec@cha.quebec.qc.ca    
Contact: Yolaine Hebert     418-649-0252 ext 5865     yolaine.hebert.cha@ssss.gouv.qc.ca    
Principal Investigator: Christine Demers, MD            
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Marc A Rodger, MD Ottawa Health Research Institute, Ottawa, Canada
Principal Investigator: William Hague, MD Women's and Children's Hospital, Adelaide, Australia
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Marc A Rodger, Ottawa Health Research Institute
ClinicalTrials.gov Identifier: NCT00967382     History of Changes
Other Study ID Numbers: 1999210-01H, IND 72,350, ISRCTN 87441504, CIHR 200602MCT-157533-RFA
Study First Received: May 29, 2009
Last Updated: July 19, 2011
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
Pregnancy
Thrombophilia
High-risk pregnancy
LMWH prophylaxis
Placenta mediated pregnancy complications

Additional relevant MeSH terms:
Pregnancy Complications
Thrombophilia
Hematologic Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 24, 2012