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The Risk of Venous Clotting in Patients After Renal Transplant (REPORT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Christine Ribic, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01413464
First received: August 8, 2011
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition
Venous Thrombosis
End Stage Renal Failure With Renal Transplant
Deep Vein Thrombosis
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Risk of Thromboembolism in Patients Post Renal Transplantation (REPORT) Study

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • Deep Vein Thrombosis or Pulmonary Embolism [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Clinically significant bleeding is collected with subjective measures and is adjudicated.


Biospecimen Retention:   Samples With DNA

Plasma samples from participants are being banked at various timepoints.


Enrollment: 120
Study Start Date: March 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Eligibility

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

Consecutive patients admitted to St. Joseph's Healthcare Hamilton (McMaster University affiliated teaching hospital) to the Renal Transplant Ward for renal transplantation.

Criteria

Inclusion Criteria:

  • Patients greater than or equal to 18 years of age admitted to St. Joseph's Healthcare Hamilton for renal transplantation.

Exclusion Criteria:

  • Patients requiring therapeutic and/or bridging anticoagulation pre and post operatively.

Patients requiring therapeutic anticoagulation preoperatively and anticipate therapeutic anticoagulation postoperatively within 48 hours.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413464

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Astellas Pharma Canada, Inc.
  More Information

No publications provided

Responsible Party: Christine Ribic, Nephrologist, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01413464     History of Changes
Other Study ID Numbers: 10-3440
Study First Received: August 8, 2011
Last Updated: July 18, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Joseph's Healthcare Hamilton:
Renal Transplant
Venous Thrombosis
Deep Vein Thrombosis
Prophylaxis
Bleeding

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Kidney Failure, Chronic
Pulmonary Embolism
Renal Insufficiency
Thrombosis
Cardiovascular Diseases
Embolism
Embolism and Thrombosis
Kidney Diseases
Lung Diseases
Renal Insufficiency, Chronic
Respiratory Tract Diseases
Thromboembolism
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014