Trial record 4 of 395 for:    Open Studies | "Embolism and Thrombosis"

Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE) (ROCITP2)

This study is not yet open for participant recruitment.
Verified June 2011 by Hamilton Health Sciences Corporation
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by:
Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01357941
First received: May 19, 2011
Last updated: June 2, 2011
Last verified: June 2011
  Purpose

Pregnant women with a prior history of venous thromboembolism (VTE) are at increased risk of recurrent VTE. Current guidelines assessing the role of prophylaxis in pregnant women with prior VTE are based primarily on expert opinion and the optimal clinical management strategy remains unclear.

This multicentre, prospective cohort study aims to test the following hypotheses:

  1. Antepartum prophylaxis with fixed-dose low molecular-weight heparin (LMWH) is safe, convenient and associated with an acceptably low risk of recurrent VTE in women with a single prior episode of VTE that was either unprovoked or associated with a minor transient risk factor. (Moderate risk cohort)
  2. Withholding antepartum prophylaxis is safe (recurrence risk <1%) in pregnant women with a single prior episode of VTE provoked by a major transient risk factor. (Low risk cohort)

All study patients will receive 6 weeks of postpartum prophylaxis.


Condition
Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Assessing the Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism

Resource links provided by NLM:


Further study details as provided by Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • Symptomatic venous thromboembolism [ Time Frame: antepartum period (expected average 7 months) ] [ Designated as safety issue: Yes ]
    Symptomatic objectively confirmed recurrent VTE, including proximal DVT, non-fatal PE, and fatal PE during antepartum period


Secondary Outcome Measures:
  • Symptomatic recurrent venous thromboembolism [ Time Frame: antepartum period (expected average 7 months) and first 3 months postpartum ] [ Designated as safety issue: Yes ]
    Symptomatic recurrent VTE antepartum and within first 3 months postpartum

  • Symptomatic recurrent pulmonary embolism [ Time Frame: antepartum period (expected average 7 months) and first 3 months postpartum ] [ Designated as safety issue: Yes ]
    Symptomatic objectively confirmed recurrent PE antepartum and within first 3 months postpartum

  • Thrombocytopenia or heparin-induced thrombocytopenia (HIT) [ Time Frame: antepartum period (expected average 7 months) ] [ Designated as safety issue: Yes ]
    Thrombocytopenia or HIT during antepartum period

  • Symptomatic osteoporosis [ Time Frame: antepartum period (expected average 7 months) and first 3 months postpartum ] [ Designated as safety issue: Yes ]
    Symptomatic osteoporosis antepartum and within first 3 months postpartum

  • Other complications [ Time Frame: antepartum (expected average 7 months) and within first 3 months postpartum ] [ Designated as safety issue: Yes ]
    Other complications sufficient to stop treatment (e.g., local and systemic reactions) antepartum and within first 3 months postpartum

  • Pregnancy complications and outcomes [ Time Frame: antepartum period (expected average 7 months) ] [ Designated as safety issue: Yes ]
    Pregnancy complications and outcomes including fetal death, pre-eclampsia, toxemia, intrauterine growth restriction, prematurity during antepartum period

  • Fetal anomalies [ Time Frame: antepartum (expected average 7 months) and during first 3 months postpartum ] [ Designated as safety issue: No ]
    Fetal anomalies

  • Major and minor bleeding [ Time Frame: antepartum (expected average 7 months) ] [ Designated as safety issue: Yes ]
    Major and minor bleeding


Estimated Enrollment: 203
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prior VTE minor transient risk factor
Pregnant women with a single prior VTE episode that was either unprovoked or associated with a minor transient risk factor - Prophylaxis with fixed-dose LMWH
Prior VTE major transient risk factor
Pregnant women with a single prior VTE episode that was provoked by a major transient risk factor - Surveillance

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive pregnant women with prior VTE diagnosed with accurate testing.

Criteria

Inclusion Criteria:

  • Confirmed pregnancy (positive serum or urine)
  • At least 18 years of age
  • History of one prior episode of VTE consisting of DVT (diagnosed by compression ultrasonography [CUS] or venography) and/or PE (diagnosed by ventilation-perfusion [V/Q] lung scintigraphy, computed tomographic pulmonary angiography [CTPA], or traditional pulmonary angiography)

Exclusion Criteria:

  • Ongoing need for therapeutic anticoagulation for prevention or treatment of cardioembolic stroke
  • Known high-risk thrombophilia (specifically antithrombin deficiency, protein S deficiency, protein C deficiency, homozygosity for the factor V Leiden or prothrombin G20210A mutations, antiphospholipid antibody or compound abnormalities)
  • VTE within 3 months of the current pregnancy
  • Clinical risk factor for initial episode of VTE, if present, not resolved (excluding pregnancy)
  • Known contraindication to anticoagulation (including active, uncontrolled bleeding or major bleed within the previous 4 weeks)
  • For patients with prior unprovoked VTE, contraindication to LMWH (including allergy, HIT, impaired renal function, osteoporosis)
  • Geographic or social factors precluding follow-up
  • Inability or unwillingness to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357941

Contacts
Contact: Shannon M Bates, MD 905-521-2100 ext 73928 batesm@mcmaster.ca
Contact: Nancy Lloyd, MSc 905-522-1155 ext 33269 lloydn@mcmaster.ca

Locations
Canada, Ontario
McMaster University Medical Centre Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Shannon M Bates, MD    905-521-2100 ext 73928    batesm@mcmaster.ca   
Principal Investigator: Shannon M Bates, MD         
St. Joseph's Healthcare Hamilton Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: James D Douketis, MD    905-522-1155 ext 36178    jdouket@mcmaster.ca   
Principal Investigator: James D Douketis, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Shannon M Bates, MD McMaster University Medical Centre
  More Information

Publications:
Responsible Party: Dr. Shannon Bates, McMaster University Medical Centre
ClinicalTrials.gov Identifier: NCT01357941     History of Changes
Other Study ID Numbers: HHS130511
Study First Received: May 19, 2011
Last Updated: June 2, 2011
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Keywords provided by Hamilton Health Sciences Corporation:
embolism and thrombosis
venous thromboembolism
thromboembolism
deep vein thrombosis
pulmonary embolism
thromboprophylaxis
thrombosis
cardiovascular diseases
venous thrombosis
vascular diseases
anticoagulants
hematologic agents
cardiovascular agents
enoxaparin
dalteparin
tinzaparin
pregnancy complications

Additional relevant MeSH terms:
Embolism and Thrombosis
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014