Venous ThrombosisREPORTNCT01413464
The Risk of Venous Clotting in Patients After Renal Transplant
An observational study of Venous Thrombosis and End Stage Renal Failure With Renal Transplant, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Clots that develop in the deep veins of the legs or the lungs can result in pain, heart and lung disease and may lead to death if unrecognized or not treated. Risk factors for developing clots include surgery, hospitalization and/or being immobile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis, End Stage Renal Failure With Renal Transplant, Deep Vein Thrombosis
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Sep 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients admitted to St. Joseph's Healthcare Hamilton (McMaster University affiliated teaching hospital) to the Renal Transplant Ward for renal transplantation.
Who may be able to join
- Patients greater than or equal to 18 years of age admitted to St. Joseph's Healthcare Hamilton for renal transplantation.
Who cannot join
- Patients requiring therapeutic and/or bridging anticoagulation pre and post operatively.
- Patients requiring therapeutic anticoagulation preoperatively and anticipate therapeutic anticoagulation postoperatively within 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Risk of Thromboembolism in Patients Post Renal Transplantation (REPORT) Study
Clots that develop in the deep veins of the legs or the lungs can result in pain, heart and lung disease and may lead to death if unrecognized or not treated. Risk factors for developing clots include surgery, hospitalization and/or being immobile. Up to 10 to 40% of people may develop a clot during or after their hospital stay or surgery, and sometimes these clots do not cause symptoms. In order to help reduce the risk of developing a clot in the legs or lungs, many people undergoing surgery receive a small dose of a blood thinner in hospital after their surgery is completed. Although prescription of a low dose blood thinner is routine practice after most surgeries, the risk or benefit of blood thinners after kidney transplant surgery is still not clear. Given this, many transplant physicians differ in prescribing practices of low dose blood thinners after kidney transplant surgery. More information is needed about the risk of clotting and bleeding in people after kidney transplant surgery so that physicians can become more unified in deciding whether a low dose blood thinner would protect patients after kidney transplant without producing harm.
The REPORT study is designed to examine the risk of clotting in the legs or lungs in people after kidney transplant surgery as well as the risk of bleeding. Ultrasounds of the legs will be performed at various time points after surgery for up to one year to screen for blood clots. People participating in this study will also be screened and monitored for bleeding after surgery. Although this study will also examine the prescription practices of physicians, no blood thinners will be given or withheld from participants as a result of this study. Physicians will prescribe blood thinners as per their usual practice after kidney transplant. Overall, the goal of the study is to find out how frequent clotting and/or bleeding is after kidney transplant surgery, which will help in making recommendations regarding the use of low dose blood thinners in people after their surgery.
Read more
Ultrasound scanning of the legs is a safe test that does not cause physical pain and has no risk of causing injury. Participation in this study will provide the benefit of additional monitoring with several ultrasound tests after surgery, screening for clots in the legs which can cause health risks and even death if unrecognized. If a clot is found, it will be treated promptly and according to current medical standards under the care of a specialist.
In the long term, the results of this study will help improve health care delivery to people undergoing kidney transplant with the goal of decreasing potential complications such as clotting and/or bleeding. Currently, there are no guidelines available to guide physician's in the use of a low dose blood thinner after kidney transplant surgery. This study will help determine the risk of clotting or bleeding and help us make recommendations that will reduce potential risks and complications for people undergoing kidney transplant in the future.
- Conditions
- Venous Thrombosis, End Stage Renal Failure With Renal Transplant, Deep Vein Thrombosis, Pulmonary Embolism
- Keywords
- Renal Transplant, Venous Thrombosis, Deep Vein Thrombosis, Prophylaxis, Bleeding
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep Vein Thrombosis or Pulmonary Embolism
Venous thromboembolism (deep vein thrombosis and pulmonary embolism) is screened for at regular study intervals for 12 months and upon clinical suspicion of an event.
Measured: 12 months
Secondary outcomes (1)
Bleeding
Clinically significant bleeding is collected with subjective measures and is adjudicated.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Canada, Inc.
- Responsible party
- Principal investigator, Christine Ribic, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413464
- Sponsor's protocol ID
- 10-3440
- Acronym
- REPORT
- Status last verified
- Jul 2013
- First submitted
- 8 Aug 2011
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Thromboembolism in Patients Post Renal Transplantation (REPORT) Study
- ClinicalTrials.gov ID
- NCT01413464
- Acronym / sponsor ID
- REPORT / 10-3440
- Conditions
- Venous Thrombosis, End Stage Renal Failure With Renal Transplant, Deep Vein Thrombosis, Pulmonary Embolism
- Keywords
- Renal Transplant, Venous Thrombosis, Deep Vein Thrombosis, Prophylaxis, Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Astellas Pharma Canada, Inc.
- Study start
- Mar 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 10 Aug 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.
Clots that develop in the deep veins of the legs or the lungs can result in pain, heart and lung disease and may lead to death if unrecognized or not treated. Risk factors for developing clots include surgery, hospitalization and/or being immobile. Up to 10 to 40% of people may develop a clot during or after their hospital stay or surgery, and sometimes these clots do not cause symptoms. In order to help reduce the risk of developing a clot in the legs or lungs, many people undergoing surgery receive a small dose of a blood thinner in hospital after their surgery is completed. Although prescription of a low dose blood thinner is routine practice after most surgeries, the risk or benefit of blood thinners after kidney transplant surgery is still not clear. Given this, many transplant physicians differ in prescribing practices of low dose blood thinners after kidney transplant surgery. More information is needed about the risk of clotting and bleeding in people after kidney transplant surgery so that physicians can become more unified in deciding whether a low dose blood thinner would protect patients after kidney transplant without producing harm.
The REPORT study is designed to examine the risk of clotting in the legs or lungs in people after kidney transplant surgery as well as the risk of bleeding. Ultrasounds of the legs will be performed at various time points after surgery for up to one year to screen for blood clots. People participating in this study will also be screened and monitored for bleeding after surgery. Although this study will also examine the prescription practices of physicians, no blood thinners will be given or withheld from participants as a result of this study. Physicians will prescribe blood thinners as per their usual practice after kidney transplant. Overall, the goal of the study is to find out how frequent clotting and/or bleeding is after kidney transplant surgery, which will help in making recommendations regarding the use of low dose blood thinners in people after their surgery.
Ultrasound scanning of the legs is a safe test that does not cause physical pain and has no risk of causing injury. Participation in this study will provide the benefit of additional monitoring with several ultrasound tests after surgery, screening for clots in the legs which can cause health risks and even death if unrecognized. If a clot is found, it will be treated promptly and according to current medical standards under the care of a specialist.
In the long term, the results of this study will help improve health care delivery to people undergoing kidney transplant with the goal of decreasing potential complications such as clotting and/or bleeding. Currently, there are no guidelines available to guide physician's in the use of a low dose blood thinner after kidney transplant surgery. This study will help determine the risk of clotting or bleeding and help us make recommendations that will reduce potential risks and complications for people undergoing kidney transplant in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients admitted to St. Joseph's Healthcare Hamilton (McMaster University affiliated teaching hospital) to the Renal Transplant Ward for renal transplantation.
Key inclusion criteria (1 listed)
- Patients greater than or equal to 18 years of age admitted to St. Joseph's Healthcare Hamilton for renal transplantation.
Key exclusion criteria (2 listed)
- Patients requiring therapeutic and/or bridging anticoagulation pre and post operatively.
- Patients requiring therapeutic anticoagulation preoperatively and anticipate therapeutic anticoagulation postoperatively within 48 hours.
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
Deep Vein Thrombosis or Pulmonary Embolism
Time frame: 12 months
Venous thromboembolism (deep vein thrombosis and pulmonary embolism) is screened for at regular study intervals for 12 months and upon clinical suspicion of an event.
1 secondary outcome
Bleeding
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis and End Stage Renal Failure With Renal Transplant, run by St. Joseph's Healthcare Hamilton at 1 site 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 1 inclusion and 2 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 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Deep Vein Thrombosis or Pulmonary Embolism (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2013.