Status:
COMPLETED
The STOP CLOT Pilot Study: Study of Low Molecular Weight Heparin in High Risk Cesarean Section
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
LEO Pharma
Conditions:
Deep Vein Thrombosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Venous thromboembolism (VTE) remains the most common cause of maternal death in the developed world. VTE includes two conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT refers to ...
Detailed Description
BACKGROUND: Venous thromboembolism (VTE) remains the most common cause of maternal mortality in the developed world. VTE is up to 10 times more common in pregnant women than non-pregnant women of comp...
Eligibility Criteria
Inclusion
- Inclusion Criteria (must meet inclusion criteria 1, 2 and 3):
- At high risk for thromboembolism (any one of the following):
- Age \> 35 years
- Obesity (\> 80 kg)
- Para \4
- Gross varicose veins
- Current infection
- Pre-eclampsia
- Immobility prior to surgery (\> 4 days)
- Major current disease: includes heart or lung disease, cancer, inflammatory bowel disease, and nephrotic syndrome.
- Emergency cesarean section in labour
- Extended major pelvic or abdominal surgery (e.g. cesarean hysterectomy)
- Patients with a family history of VTE
- History of superficial phlebitis
- Delivered by cesarean section (emergency or planned)
- Signed, informed consent
- Exclusion Criteria (must not meet any of the following criteria):
- Greater than 36 hours since delivery
- Need for anticoagulation, including:
- Women with a confirmed thrombophilia
- Women with paralysis of lower limbs
- Women with personal history of VTE
- Women with antiphospholipid antibody syndrome (APLA)
- Women with mechanical heart valves
- Contraindication to heparin therapy, including:
- History of heparin induced thrombocytopenia
- Platelet count of less than 100,000 x 10\^6/L
- Hemoglobin \<= 90 g/L or a greater than 30 g/L drop in hemoglobin compared to last antepartum result
- History of osteoporosis
- History of steroid use (one week or more)
- Active bleeding
- Documented peptic ulcer within 6 weeks
- Heparin, bisulfite, or fish allergy
- Severe hypertension (systolic blood pressure \[SBP\] \> 200 and/or diastolic blood pressure \[DBP\] \> 120)
- Severe hepatic failure (International Normalized Ratio \[INR\] \> 1.8)
- Women with serum creatinine \> 80 and an abnormal 24 hour creatinine clearance.
- Contraindications to magnetic resonance imaging (MRI), including:
- Women with electrically, magnetically or mechanically activated implants
- Women with claustrophobia
- Women \< 18 years of age
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00225108
Start Date
July 1 2002
End Date
September 1 2006
Last Update
February 7 2018
Active Locations (1)
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1
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6