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| 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. |
| 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 |
Inclusion Criteria:One or more of the following
Previous recurrent miscarriage:
Women with one or more of the following thrombotic events:
Exclusion Criteria:
Contraindication to heparin therapy
Need for anticoagulants, discretion of the investigator such as but not limited to:
Prior idiopathic proximal VTE:
Contacts and Locations| 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 |
| 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 | |
| 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
| 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 |
|
Pregnancy Thrombophilia High-risk pregnancy LMWH prophylaxis Placenta mediated pregnancy complications |
|
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 |