Registry of Patients Prescribed Anticoagulation
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/9/2019 |
| Start Date: | March 1, 2013 |
| End Date: | March 1, 2023 |
| Contact: | Danielle T Vlazny, P.A.-C., M.S. |
| Email: | vlazny.danielle@mayo.edu |
| Phone: | 507-266-1111 |
Standardized, Guidelines Directed But Patients Oriented Clinical Practice Prospectively Registered
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.
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.
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.
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.
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.
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