Registry of Patients Prescribed Anticoagulation (STAGPOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03504007|
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : July 5, 2019
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 thromboembolism (VTE).This study is the ongoing registry of clinical practice with standardized approach to patient assessment and therapy. As most of registries it does not have any definite number of recruited subjects or the date of study completion but provides anticipated number of recruited subjects and the time of anticipated enrolment which was provided only because of formal requirement related to structure of ClinicalTrials.gov website. This number will be updated and upgraded as we continue this registry.
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|
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.
At the most recent update, over 2775 patients were enrolled. These data are used to analyze currently relevant clinical questions and are presented and published.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Standardized, Guidelines Directed But Patients Oriented Clinical Practice Prospectively Registered|
|Actual Study Start Date :||March 1, 2013|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||March 1, 2023|
- 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
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
|Contact: Danielle T Vlazny, P.A.-C., M.S.||firstname.lastname@example.org|
|Contact: Waldemar E Wysokinski, MD||507-266-1970||Wysokinski.Waldemar@mayo.edu|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Waldemar Wysokinski, MD|
|Principal Investigator: Waldemar Wysokinski, MD|
|Principal Investigator:||Waldemar E Wysokinski, MD||Mayo Clinic|