Venous ThromboembolismROCITP2NCT01357941
Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)
An observational study of Venous Thromboembolism and Deep Vein Thrombosis, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism
- How many people
- 203 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2011to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive pregnant women with prior VTE diagnosed with accurate testing.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
Shannon M Bates, MD, 905-521-2100 ext. 73928, batesm@mcmaster.ca
Shannon M Bates, MD
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
James D Douketis, MD, 905-522-1155 ext. 36178, jdouket@mcmaster.ca
James D Douketis, MD
About this study
Official title: Prospective Study Assessing the Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism
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:
Read more
- 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)
- 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.
- Keywords
- venous thromboembolism, thromboembolism, deep vein thrombosis, pulmonary embolism, thromboprophylaxis, thrombosis, embolism and thrombosis, cardiovascular diseases, venous thrombosis, vascular diseases, anticoagulants, hematologic agents, cardiovascular agents, enoxaparin, dalteparin, tinzaparin, pregnancy complications
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Thromboembolism, Thrombosis, Embolism and Thrombosis, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic venous thromboembolism
Symptomatic objectively confirmed recurrent VTE, including proximal DVT, non-fatal PE, and fatal PE during antepartum period
Measured: antepartum period (expected average 7 months)
Secondary outcomes (8)
Symptomatic recurrent venous thromboembolism
Symptomatic recurrent VTE antepartum and within first 3 months postpartum
Measured: antepartum period (expected average 7 months) and first 3 months postpartum
Symptomatic recurrent pulmonary embolism
Symptomatic objectively confirmed recurrent PE antepartum and within first 3 months postpartum
Measured: antepartum period (expected average 7 months) and first 3 months postpartum
Thrombocytopenia or heparin-induced thrombocytopenia (HIT)
Thrombocytopenia or HIT during antepartum period
Measured: antepartum period (expected average 7 months)
Symptomatic osteoporosis
Symptomatic osteoporosis antepartum and within first 3 months postpartum
Measured: antepartum period (expected average 7 months) and first 3 months postpartum
Other complications
Other complications sufficient to stop treatment (e.g., local and systemic reactions) antepartum and within first 3 months postpartum
Measured: antepartum (expected average 7 months) and within first 3 months postpartum
Pregnancy complications and outcomes
Pregnancy complications and outcomes including fetal death, pre-eclampsia, toxemia, intrauterine growth restriction, prematurity during antepartum period
Measured: antepartum period (expected average 7 months)
Fetal anomalies
Fetal anomalies
Measured: antepartum (expected average 7 months) and during first 3 months postpartum
Major and minor bleeding
Major and minor bleeding
Measured: antepartum (expected average 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Investigators
- Shannon M Bates, MD, Principal investigator, McMaster University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357941
- Sponsor's protocol ID
- HHS130511
- Acronym
- ROCITP2
- Status last verified
- Jun 2011
- First submitted
- 19 May 2011
- Last updated
- 3 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brill-Edwards P, Ginsberg JS, Gent M, Hirsh J, Burrows R, Kearon C, Geerts W, Kovacs M, Weitz JI, Robinson KS, Whittom R, Couture G; Recurrence of Clot in This Pregnancy Study Group. Safety of withholding heparin in pregnant women with a history of venous thromboembolism. Recurrence of Clot in This Pregnancy Study Group. N Engl J Med. 2000 Nov 16;343(20):1439-44. doi: 10.1056/NEJM200011163432002.
PubMed 11078768
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Assessing the Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT01357941
- Acronym / sponsor ID
- ROCITP2 / HHS130511
- Keywords
- venous thromboembolism, thromboembolism, deep vein thrombosis, pulmonary embolism, thromboprophylaxis, thrombosis, embolism and thrombosis, cardiovascular diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 203 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 23 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive pregnant women with prior VTE diagnosed with accurate testing.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptomatic venous thromboembolism
Time frame: antepartum period (expected average 7 months)
Symptomatic objectively confirmed recurrent VTE, including proximal DVT, non-fatal PE, and fatal PE during antepartum period
8 secondary outcomes
Symptomatic recurrent venous thromboembolism
Time frame: antepartum period (expected average 7 months) and first 3 months postpartum
Symptomatic recurrent pulmonary embolism
Time frame: antepartum period (expected average 7 months) and first 3 months postpartum
Thrombocytopenia or heparin-induced thrombocytopenia (HIT)
Time frame: antepartum period (expected average 7 months)
Symptomatic osteoporosis
Time frame: antepartum period (expected average 7 months) and first 3 months postpartum
Other complications
Time frame: antepartum (expected average 7 months) and within first 3 months postpartum
Pregnancy complications and outcomes
Time frame: antepartum period (expected average 7 months)
Fetal anomalies
Time frame: antepartum (expected average 7 months) and during first 3 months postpartum
Major and minor bleeding
Time frame: antepartum (expected average 7 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2011.
- Background: PubMed 11078768Brill-Edwards P, Ginsberg JS, Gent M, Hirsh J, Burrows R, Kearon C, Geerts W, Kovacs M, Weitz JI, Robinson KS, Whittom R, Couture G; Recurrence of Clot in This Pregnancy Study Group. Safety of withholding heparin in pregnant women with a history of venous thromboembolism. Recurrence of Clot in This Pregnancy Study Group. N Engl J Med. 2000 Nov 16;343(20):1439-44. doi: 10.1056/NEJM200011163432002.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon M Bates, MD principal investigator
McMaster University Medical Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Deep Vein Thrombosis, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shannon M Bates, MD (905-521-2100 ext. 73928, batesm@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic venous thromboembolism (time frame: antepartum period (expected average 7 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01357941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2011.