Know Cancer

or
forgot password

Epidemiology of Venous Thromboembolism: Analyses and Publications From the DVT FREE Database


N/A
N/A
N/A
Not Enrolling
Both
Venous Thromboembolism, Pulmonary Embolism, Cancer, Deep Vein Thrombosis, COPD

Thank you

Trial Information

Epidemiology of Venous Thromboembolism: Analyses and Publications From the DVT FREE Database


BACKGROUND:

The Venous Thromboembolism (VTE) Research Group has explored and studied the epidemiology of
DVT and pulmonary embolism (PE) for more than 2 decades. The earliest analyses were done
with the database from the Framingham Heart Study. Subsequent analyses were undertaken
using the Nurses' Health Study.

More than 5 years ago the DVT FREE Registry was conceived. The concept was to accrue broad
representation of patients with ultrasound-confirmed DVT throughout the US.

The Principal Investigator began initial work on this project by developing the case report
form (CRF) with Co-Investigators. After the CRF was piloted and finalized, centers were
recruited for participation. The enthusiasm in response to DVT FREE was overwhelming. The
initial investigators meetings were conducted by videoconference shortly after September 11,
2001. Accrual of patients occurred much more rapidly than projected. Within 6 months,
5,451 patients were enrolled with ultrasound-confirmed DVT at 183 participating
institutions.

Dr. Samuel Z. Goldhaber chaired the Publications Committee. The Master Paper was published
in January 2004. 3 manuscripts on subgroups and 3 manuscripts on special populations were
subsequently published under Dr. Goldhaber's supervision. The subgroup papers studied upper
extremity DVT, the relationship between DVT and symptomatic DVT and PE, and predictors of
massive DVT. The special populations papers studied gender differences in receiving
prophylaxis, utilization of vena cava filters, and pregnancy.

Though the publication record is impressive in scope, much work remains to be done. The
database is rich in information of critical importance to health care providers. The
information contained within the database should be analyzed to provide more detailed
analyses which will be used for risk factor assessment and for decision-making regarding the
implementation of VTE prophylaxis.

For the current DVT FREE publication project, we will use the database to analyze findings
that will yield 8 publications in special populations: 1) medically ill hospitalized
patients, 2) cancer patients, 3) nonorthopedic general surgery patients, 4) orthopedic
surgery patients, 5) long-haul travel patients, 6) COPD Patients, 7) Renal Patients, and 8)
Elderly Patients.

PROJECT DESCRIPTION:

1. Medically Ill Hospitalized Patients:

Medically ill hospitalized patients are the most important subgroup to study. These
patients often do not receive guideline-recommended prophylaxis. We believe that
medically ill hospitalized patients are underserved.

For this DVT FREE publication, we will exclude all patients who had surgery within the
past 3 months. We will also exclude women who were pregnant or postpartum. All other
patients will be included in these analyses. They will be stratified according to age,
height, weight, body mass index (BMI), gender, and whether they received prophylaxis.

2. Cancer Patients:

Cancer patients have received increasing attention because of the relationship between
cancer and DVT. For example, the National Comprehensive Cancer Network (NCCN)
organized a special committee to write consensus guidelines for prevention and
treatment of DVT in this patient population.

For this DVT FREE publication, we will include all patients with cancer. We will also
include whether the cancer was active and whether the patient is receiving ongoing
radiation therapy or chemotherapy. These cancer patients will be stratified according
to age, height, weight, BMI, gender, and whether they received prophylaxis.

3. Nonorthopedic General Surgery Patients:

For this DVT FREE publication, we will include all nonorthopedic general surgery
patients. These patients will have undergone surgery within the 3 months prior to DVT.
We will also explore the type of surgery (excluding orthopedic surgery) and type of
anesthetic that was used. These patients will be stratified according to age, height,
weight, BMI, gender, and whether they received prophylaxis.

4. Orthopedic Surgery Patients:

For this DVT FREE publication, we will include all orthopedic surgery patients. We
will also include patients who suffered hip fracture, pelvic fracture, upper extremity
fracture, lower extremity fracture, or other fracture within 30 days prior to
enrollment. We will also include patients with major trauma to the spine, pelvis, or
upper or lower extremities. These patients will be stratified according to age,
height, weight, BMI, gender, and whether they received prophylaxis.

5. Congestive Heart Failure (CHF)

6. COPD Patients:

For this DVT FREE publication, we will include all patients with COPD. These patients
will be stratified according to age, height, weight, BMI, gender, and whether they
received prophylaxis.

7. Renal Patients:

For this DVT FREE publication, we will include all renal patients. These patients will
be stratified according to age, height, weight, BMI, gender, and whether they received
prophylaxis.

8. Elderly Patients:

For this DVT FREE publication, we will include all elderly patients. For this study we will
define elderly as 70 years of age or older. These patients will be stratified according to
age, height, weight, BMI, gender, and whether they received prophylaxis.


Inclusion Criteria:



- Ultrasound-confirmed DVT patients from 183 institutions.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Principal Investigator

Samuel Z. Goldhaber, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital

Authority:

United States: Institutional Review Board

Study ID:

2006-P-000820

NCT ID:

NCT00456196

Start Date:

April 2006

Completion Date:

June 2009

Related Keywords:

  • Venous Thromboembolism
  • Pulmonary Embolism
  • Cancer
  • Deep Vein Thrombosis
  • COPD
  • COPD
  • Thrombosis
  • Cancer
  • Renal
  • Elderly
  • Surgery
  • Orthopedic Surgery
  • Medically Ill
  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Anticoagulation
  • Embolism
  • Pulmonary Disease, Chronic Obstructive
  • Pulmonary Embolism
  • Thromboembolism
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism

Name

Location

Brigham and Women's HospitalBoston, Massachusetts  02115