HematomaPhase 4BRUISECONTROLNCT00800137
Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial
A Phase 4 study testing low molecular weight heparin or unfractionated heparin and Warfarin or coumadin in people with Hematoma, run by Ottawa Heart Institute Research Corporation at 22 sites in 2 countries.
Trial summary
Many cardiac patients requiring device (defibrillator or pacemaker) related surgery are on chronic oral anticoagulation therapy (usually coumadin). The risk of blood clot formation related to stopping oral anti-coagulant therapy is currently managed by using bridging heparin therapy in patients with moderate to high… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematoma
- What is being tested?
- low molecular weight heparin or unfractionated heparin and Warfarin or coumadin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 984 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Dec 2008to Mar 2013
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient undergoing elective device surgery (i.e. de novo device implantation or pulse generator change or lead replacement or pocket revision)
- Patient at moderate or high risk of arterial thrombo-embolic events (ATE) or high risk of venous thrombo-embolic events (VTE) (defined as one or more of following):
- Prosthetic mitral valve replacement
- Caged ball or tilting disc aortic valve prosthesis
- Bileaflet aortic valve prosthesis and one or more of: AF (atrial Fibrillation/Atrial Flutter), prior stroke or TIA, hypertension, diabetes, CHF age >75
- AFib/Flutter associated with rheumatic valvular heart disease
Show all 12Show fewer
- Non-rheumatic AFib/Flutter and CHADS2 risk criteria SCORE > 2
- Non-rheumatic AFib/Flutter and stroke or TIA (within 3 months)
- Persistent/permanent AFib/Flutter on day of acceptance for device surgery AND plan for cardioversion or DFT testing at device implant
- Recent (within 3 months) VTE
- Severe thrombophilia (Protein C or S deficiency or anti-thrombin or anti-phospholipid antibodies or multiple abnormalities)
- Willing to self-inject or have a relative or friend or nurse inject LMWH
Who cannot join
- Unable ro unwilling to provide informed consent
- History of noncompliance of medical therapy
- Renal failure with Cr > 180 umol/l
- Prior Heparin induced thrombocytopenia
- Active device infection
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
Canada21 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
Mazankowski Alberta Heart Institute
Edmonton, Alberta
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Hamilton Health Science Center
Hamilton, Ontario, L8L 2X2
Kingston General Hospital
Kingston, Ontario, K7L 2V7
St. Mary's General Hospital
Kitchener, Ontario, N2M 1B2
Cité-de-la-Santé Hospital
Laval, Quebec, H7M 3L9
London Health Sciences Center
London, Ontario, N6A 5A5
Centre Hospitalier de L'Université de Montréal
Montreal, Quebec, H2W 1T8
McGill University Health Center
Montreal, Quebec, H3G 1A4
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Hôpital Laval
Québec, Quebec, G1V 4G5
St. John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Rouge Valley Hospital
Scarborough Village, Ontario, M1E 5E9
Sherbrooke University Hospital Centre CHUS
Sherbrooke, Quebec, J1H 5N4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Mike's Hospital
Toronto, Ontario, M5B 1W8
Royal Jubilee Hospital
Victoria, British Columbia, V8R 4R2
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, R2H 2A6
Brazil1 site
Instituto de Cardiologia - Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, 90620 - 000
About this study
Official title: Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL)
Many cardiac patients requiring device (defibrillator or pacemaker) related surgery are on chronic oral anticoagulation therapy (usually coumadin). The risk of blood clot formation related to stopping oral anti-coagulant therapy is currently managed by using bridging heparin therapy in patients with moderate to high risk of blood clot formation. There is a substantial risk of bleeding in the pocket where the device is situated (pocket hematoma)related to bridging therapy. The purpose of this study is to compare the current standard of care of bridging with heparin to an experimental strategy of continuing coumadin therapy in higher risk patients undergoing device surgery, with the hypothesis being that the continued oral anti-coagulation group will have a lower pocket hematoma rate as compared to the bridging with heparin group.
Read the detailed description
Eligible patients will be equally randomized (1:1) to the Conventional/control arm (bridging anti-coagulation)or to the Experimental arm (continued coumadin). In the Conventional arm there are 2 options. Patients with greater than 5 days pre-implant will discontinue oral anti-coagulant (coumadin) 5 days before the procedure,and start full therapeutic doses of subcutaneous low molecular weight heparin (LMWH)3 days before the procedure. Patients with less than 5 days to implant can be given Vitamin K at the investigator's discretion and start full therapeutic doses of either subcutaneous LMWH or IV unfractionated Heparin (choice is at investigator discretion) when the INR is below the therapeutic range for the patient (usually greater than or equal to 2; 2.5 for some valve patients) and surgery to proceed when INR is less than 1.6. Oral anti-coagulant (coumadin) will resume on the evening of the procedure. Full dose LMWH injections or full dose IV heparin will be started 24 hours after surgery.
In the Experimental arm patients will continue on their oral anti-coagulant (coumadin). The INR on the day of surgery will be < 3.0.
ASA will be continued in all patients. Plavix will be continued in patients with drug-eluting stents.
Patients will be monitored for the development of any hematoma or bleeding event during admission. There will be a unblinded team responsible for device implant and follow-up and a blinded team responsible to monitor any bleeding events or hematoma and determine if it meets the primary endpoint criteria for the study. The blinded team will have no knowledge of the treatment arm and will be involved only if the patient develops a hematoma or bleeding event. All hematomas and bleeding events will be followed until resolution.
- Conditions
- Hematoma
- Being tested
- low molecular weight heparin or unfractionated heparin, Warfarin or coumadin
- Keywords
- coumadin, device surgery, pocket hematoma, Pocket hematoma and device surgery
- Medical subject headings
- Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low molecular weight heparin or unfractionated heparinDrug
For elective patients with greater than 5 days pre-implant; discontinue oral anti-coagulation (coumadin) 5 days before the procedure. Full therapeutic doses of subcutaneous LMWH 3 days before the procedure.
Patients with less than 5 days to implant can be given vitamin K (up to 2 mg) at the investigator discretion and start full therapeutic doses of either subcutaneous LMWH or IV Unfractionated Heparin (choice is at investigator's discretion) when INR is below the upper limit of the prescribed therapeutic range for the patient (usually greater than or equal to 2; 2.5 for some valve patients) and surgery to proceed when INR is less than 1.6.
Last dose given in the morning(ie. > 24 hours)of the day prior to the procedure.
Oral anti-coagulation (coumadin) will be resumed on the evening of the procedure.
Full dose LMWH or full dose IV heparin will be restarted 24 hours after surgery.
Warfarin or coumadinDrug
Continue on oral anti-coagulant (coumadin). INR on the day of surgery will be < 3.0
| Study group | Role | What they receive |
|---|---|---|
| Bridging anti-coagulation | Active comparator | Low Molecular Weight Heparin or IV unfractionated Heparin Receives: Drug: low molecular weight heparin or unfractionated heparin |
| Continued oral anti-coagulation | Experimental | Coumadin Receives: Drug: Warfarin or coumadin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant hematoma (defined as hematoma requiring reoperation and/or transfusion and/or unplanned or prolonged hospitalization and/or interruption of LMWH or IV heparin or oral anti-coagulant.
Measured: Device implant until first routine post-op visit
Secondary outcomes (1)
Components of the primary outcome,composite of all other major peri-operative bleeding events and thrombo-embolic events.
Measured: Device implant to first routine post-op visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: At time of pre-specified 2nd interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HematomaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 984 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, David Birnie, Ottawa Heart Institute Research Corporation
- Investigators
- David Birnie, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800137
- Sponsor's protocol ID
- UOHI-02
- Acronym
- BRUISECONTROL
- Status last verified
- Aug 2018
- First submitted
- 26 Nov 2008
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Birnie DH, Healey JS, Wells GA, Verma A, Tang AS, Krahn AD, Simpson CS, Ayala-Paredes F, Coutu B, Leiria TL, Essebag V; BRUISE CONTROL Investigators. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013 May 30;368(22):2084-93. doi: 10.1056/NEJMoa1302946. Epub 2013 May 9.
PubMed 23659733Essebag V, Healey JS, Joza J, Nery PB, Kalfon E, Leiria TLL, Verma A, Ayala-Paredes F, Coutu B, Sumner GL, Becker G, Philippon F, Eikelboom J, Sandhu RK, Sapp J, Leather R, Yung D, Thibault B, Simpson CS, Ahmad K, Toal S, Sturmer M, Kavanagh K, Crystal E, Wells GA, Krahn AD, Birnie DH. Effect of Direct Oral Anticoagulants, Warfarin, and Antiplatelet Agents on Risk of Device Pocket Hematoma: Combined Analysis of BRUISE CONTROL 1 and 2. Circ Arrhythm Electrophysiol. 2019 Oct;12(10):e007545. doi: 10.1161/CIRCEP.119.007545. Epub 2019 Oct 15.
PubMed 31610718Essebag V, AlTurki A, Proietti R, Healey JS, Wells GA, Verma A, Krahn AD, Simpson CS, Ayala-Paredes F, Coutu B, Leather R, Ahmad K, Toal S, Sapp J, Sturmer M, Kavanagh K, Crystal E, Leiria TLL, Seifer C, Rinne C, Birnie D; BRUISE CONTROL Investigators. Concomitant anti-platelet therapy in warfarin-treated patients undergoing cardiac rhythm device implantation: A secondary analysis of the BRUISE CONTROL trial. Int J Cardiol. 2019 Aug 1;288:87-93. doi: 10.1016/j.ijcard.2019.04.066. Epub 2019 Apr 26.
PubMed 31056413Essebag V, Verma A, Healey JS, Krahn AD, Kalfon E, Coutu B, Ayala-Paredes F, Tang AS, Sapp J, Sturmer M, Keren A, Wells GA, Birnie DH; BRUISE CONTROL Investigators. Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection: BRUISE CONTROL INFECTION Study. J Am Coll Cardiol. 2016 Mar 22;67(11):1300-8. doi: 10.1016/j.jacc.2016.01.009.
PubMed 26988951
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL)
- ClinicalTrials.gov ID
- NCT00800137
- Acronym / sponsor ID
- BRUISECONTROL / UOHI-02
- Conditions
- Hematoma
- Keywords
- coumadin, device surgery, pocket hematoma, Pocket hematoma and device surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At time of pre-specified 2nd interim analysis
- Enrolment
- 984 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Dec 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Dec 2008 (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.
Many cardiac patients requiring device (defibrillator or pacemaker) related surgery are on chronic oral anticoagulation therapy (usually coumadin). The risk of blood clot formation related to stopping oral anti-coagulant therapy is currently managed by using bridging heparin therapy in patients with moderate to high risk of blood clot formation. There is a substantial risk of bleeding in the pocket where the device is situated (pocket hematoma)related to bridging therapy. The purpose of this study is to compare the current standard of care of bridging with heparin to an experimental strategy of continuing coumadin therapy in higher risk patients undergoing device surgery, with the hypothesis being that the continued oral anti-coagulation group will have a lower pocket hematoma rate as compared to the bridging with heparin group.
Detailed description
Eligible patients will be equally randomized (1:1) to the Conventional/control arm (bridging anti-coagulation)or to the Experimental arm (continued coumadin). In the Conventional arm there are 2 options. Patients with greater than 5 days pre-implant will discontinue oral anti-coagulant (coumadin) 5 days before the procedure,and start full therapeutic doses of subcutaneous low molecular weight heparin (LMWH)3 days before the procedure. Patients with less than 5 days to implant can be given Vitamin K at the investigator's discretion and start full therapeutic doses of either subcutaneous LMWH or IV unfractionated Heparin (choice is at investigator discretion) when the INR is below the therapeutic range for the patient (usually greater than or equal to 2; 2.5 for some valve patients) and surgery to proceed when INR is less than 1.6. Oral anti-coagulant (coumadin) will resume on the evening of the procedure. Full dose LMWH injections or full dose IV heparin will be started 24 hours after surgery.
In the Experimental arm patients will continue on their oral anti-coagulant (coumadin). The INR on the day of surgery will be < 3.0.
ASA will be continued in all patients. Plavix will be continued in patients with drug-eluting stents.
Patients will be monitored for the development of any hematoma or bleeding event during admission. There will be a unblinded team responsible for device implant and follow-up and a blinded team responsible to monitor any bleeding events or hematoma and determine if it meets the primary endpoint criteria for the study. The blinded team will have no knowledge of the treatment arm and will be involved only if the patient develops a hematoma or bleeding event. All hematomas and bleeding events will be followed until resolution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bridging anti-coagulation | Active comparator | Drug: low molecular weight heparin or unfractionated heparinLow Molecular Weight Heparin or IV unfractionated Heparin |
| Continued oral anti-coagulation | Experimental | Drug: Warfarin or coumadinCoumadin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Any patient undergoing elective device surgery (i.e. de novo device implantation or pulse generator change or lead replacement or pocket revision)
- Patient at moderate or high risk of arterial thrombo-embolic events (ATE) or high risk of venous thrombo-embolic events (VTE) (defined as one or more of following):
- Willing to self-inject or have a relative or friend or nurse inject LMWH
Key exclusion criteria (5 listed)
- Unable ro unwilling to provide informed consent
- History of noncompliance of medical therapy
- Renal failure with Cr > 180 umol/l
- Prior Heparin induced thrombocytopenia
- Active device infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low molecular weight heparin or unfractionated heparinFor elective patients with greater than 5 days pre-implant; discontinue oral anti-coagulation (coumadin) 5 days before the procedure. Full therapeutic doses of subcutaneous LMWH 3 days before the procedure. Patients with less than 5 days to implant can be given vitamin K (up to 2 mg) at the investigator discretion and start full therapeutic doses of either subcutaneous LMWH or IV Unfractionated Heparin (choice is at investigator's discretion) when INR is below the upper limit of the prescribed therapeutic range for the patient (usually greater than or equal to 2; 2.5 for some valve patients) and surgery to proceed when INR is less than 1.6. Last dose given in the morning(ie. > 24 hours)of the day prior to the procedure. Oral anti-coagulation (coumadin) will be resumed on the evening of the procedure. Full dose LMWH or full dose IV heparin will be restarted 24 hours after surgery. | Drug | Bridging anti-coagulation |
| Warfarin or coumadinContinue on oral anti-coagulant (coumadin). INR on the day of surgery will be < 3.0 | Drug | Continued oral anti-coagulation |
Primary outcome
Clinically significant hematoma (defined as hematoma requiring reoperation and/or transfusion and/or unplanned or prolonged hospitalization and/or interruption of LMWH or IV heparin or oral anti-coagulant.
Time frame: Device implant until first routine post-op visit
1 secondary outcome
Components of the primary outcome,composite of all other major peri-operative bleeding events and thrombo-embolic events.
Time frame: Device implant to first routine post-op visit
Results and safety
The study was stopped early (reason given: At time of pre-specified 2nd interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Results publication: PubMed 23659733Birnie DH, Healey JS, Wells GA, Verma A, Tang AS, Krahn AD, Simpson CS, Ayala-Paredes F, Coutu B, Leiria TL, Essebag V; BRUISE CONTROL Investigators. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013 May 30;368(22):2084-93. doi: 10.1056/NEJMoa1302946. Epub 2013 May 9.
- Derived from this study: PubMed 31610718Essebag V, Healey JS, Joza J, Nery PB, Kalfon E, Leiria TLL, Verma A, Ayala-Paredes F, Coutu B, Sumner GL, Becker G, Philippon F, Eikelboom J, Sandhu RK, Sapp J, Leather R, Yung D, Thibault B, Simpson CS, Ahmad K, Toal S, Sturmer M, Kavanagh K, Crystal E, Wells GA, Krahn AD, Birnie DH. Effect of Direct Oral Anticoagulants, Warfarin, and Antiplatelet Agents on Risk of Device Pocket Hematoma: Combined Analysis of BRUISE CONTROL 1 and 2. Circ Arrhythm Electrophysiol. 2019 Oct;12(10):e007545. doi: 10.1161/CIRCEP.119.007545. Epub 2019 Oct 15.
- Derived from this study: PubMed 31056413Essebag V, AlTurki A, Proietti R, Healey JS, Wells GA, Verma A, Krahn AD, Simpson CS, Ayala-Paredes F, Coutu B, Leather R, Ahmad K, Toal S, Sapp J, Sturmer M, Kavanagh K, Crystal E, Leiria TLL, Seifer C, Rinne C, Birnie D; BRUISE CONTROL Investigators. Concomitant anti-platelet therapy in warfarin-treated patients undergoing cardiac rhythm device implantation: A secondary analysis of the BRUISE CONTROL trial. Int J Cardiol. 2019 Aug 1;288:87-93. doi: 10.1016/j.ijcard.2019.04.066. Epub 2019 Apr 26.
- Derived from this study: PubMed 26988951Essebag V, Verma A, Healey JS, Krahn AD, Kalfon E, Coutu B, Ayala-Paredes F, Tang AS, Sapp J, Sturmer M, Keren A, Wells GA, Birnie DH; BRUISE CONTROL Investigators. Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection: BRUISE CONTROL INFECTION Study. J Am Coll Cardiol. 2016 Mar 22;67(11):1300-8. doi: 10.1016/j.jacc.2016.01.009.
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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.
David Birnie, MD principal investigator
Ottawa Heart Institute Research Corporation
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing low molecular weight heparin or unfractionated heparin and Warfarin or coumadin in people with Hematoma, run by Ottawa Heart Institute Research Corporation at 22 sites in 2 countries.
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 12 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Canada, Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: At time of pre-specified 2nd interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant hematoma (defined as hematoma requiring reoperation and/or transfusion and/or unplanned or prolonged hospitalization and/or interruption of LMWH or IV heparin or oral anti-coagulant. (time frame: Device implant until first routine post-op visit). 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 NCT00800137, which also lists 4 linked publications.
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 15 Aug 2018.