Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00456196
Status:
COMPLETED
Last Update Posted:
2009-07-13
First Post:
2007-04-02
Brief Title:
Epidemiology of Venous Thromboembolism
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Epidemiology of Venous Thromboembolism Analyses and Publications From the DVT FREE Database
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
More than 5 years ago the DVT FREE Registry was conceived Its database consists of 5451 ultrasound-confirmed DVT patients from 183 institutions This database is rich in information of critical importance to health care providers The information contained within the database will be revisited to provide more detailed analyses which will be used for risk factor assessment and for decision-making regarding the implementation of VTE Prophylaxis
Detailed Description:
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 5451 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 Goldhabers 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
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 5451 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 Goldhabers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None