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Registry of Patients Prescribed Anticoagulation

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ClinicalTrials.gov Identifier: NCT03504007
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Waldemar E. Wysokinski, Mayo Clinic

Brief Summary:

The Gonda Vascular Center- Thrombophilia Clinic at Mayo Clinic in Rochester, Minnesota utilizes a standardized, guideline-directed, yet patient-oriented approach for treating patients diagnosed with venous thrombo embolism (VTE).

The rates of VTE recurrence, major bleeding, clinically relevant non-major bleeding (CRNMB) and survival in patients treated with anticoagulation for acute VTE are assessed during prospective observation. VTE cases include an acute deep vein thrombosis (DVT) of lower or upper extremities, splanchnic veins, gonadal, renal, cerebral veins thrombosis and pulmonary embolism (PE). Therapy includes the whole spectrum of FDA approved anticoagulants such as "classic" agents: warfarin and heparinoids and the newer direct oral anticoagulants (DOACs) such as rivaroxaban, dabigatran, apixaban, and edoxaban.


Condition or disease
Acute Deep Vein Thrombosis Acute Pulmonary Embolism

Detailed Description:

When a patient has positive testing for acute VTE the radiologist interpreting the study contacts the Thrombophilia Center and the patient is immediately evaluated. Standardized information about guidelines endorsed anticoagulation therapy is provided in a uniform fashion with a standardized script for providers and a short summary table for the patient. This initial review also includes patient-specific cost information by contacting a pharmacy service phone-line. Patients with cancer-related VTE are counselled regarding the guideline endorsed use of low molecular heparin (LMWH) as the preferred option of anticoagulation and available data on DOACs. After the shared decision making is complete, the prescription is promptly filled at the pharmacy located within the same building, with the first dose administered within the ensuing hour. For patients with acute VTE diagnosed after hours, evaluation is accomplished in the Emergency Department; one dose of LMWH is administered and the patient is referred the next day to the Thrombophilia Clinic.

Patients with symptomatic PE or extensive symptomatic iliofemoral DVT are referred for prompt hospitalization. While in the hospital, they are consulted by a Vascular Medicine service and an appropriate follow up visit at the Thrombophilia Clinic is arranged. For patients with asymptomatic or minimally symptomatic pulmonary embolism (simplified Pulmonary Embolism Severity Index (PESI) score of 0), outpatient management is offered. All patients with cancer-associated PE are referred for lower extremity duplex ultrasound, and if symptomatic or if a central venous catheter is in place, also for upper extremity venous assessment.

Demographic and clinical data are entered into a REDCap. The registry is maintained on institutional servers, which are backed-up nightly and protected in controlled computer room with uninterrupted power supplies, data will never reside on a desktop computer system. Transfer of registry data will occur inside the Mayo Clinic firewall via our integrated high speed network. Analysis will be done using the most current version of SAS® software.


Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mayo Clinic Registry of Patients Prescribed Anticoagulation for Acute Venous Thromboembolic
Actual Study Start Date : March 1, 2013
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Incidence of symptomatic, recurrent VTE. Incidence of major bleeding [ Time Frame: 10 years ]
    Recurrent VTE clearly new compared to previous VTE. Major bleeding by ISTH definition



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mayo Clinic patients prescribed anticoagulation for treatment of acute DVT or PE. Treatment with all FDA-approved anticoagulants are captured in the database
Criteria

Inclusion Criteria:

• VTE seen at Thrombophilia Clinic and treatment with anti-coagulant is started within 14 days of VTE diagnosis date.

Exclusion Criteria:

  • Patients already on anticoagulation for other reasons or enrolled into anticoagulation clinical trials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504007


Contacts
Contact: Dalene M Bott Kitslaar, APRN CNP 507-266-3964 Bottkitslaar.Dalene@mayo.edu
Contact: Waldemar E Wysokinski, MD 507-266-1970 Wysokinski.Waldemar@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Waldemar Wysokinski, MD         
Contact    507-266-1970      
Principal Investigator: Waldemar Wysokinski, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Waldemar E Wysokinski, MD Mayo Clinic

Publications:
Responsible Party: Waldemar E. Wysokinski, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03504007     History of Changes
Other Study ID Numbers: 13-001404
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Waldemar E. Wysokinski, Mayo Clinic:
Deep Vein Thrombosis
Pulmonary Embolism
Apixaban
Rivaroxaban
Dabigatran
Edoxaban

Additional relevant MeSH terms:
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases