Plain English Summary
Background and study aims
Blood clots are a common complication after surgery on the colon and rectum, especially when performed for cancer or inflammatory bowel disease. While in the hospital, patients receive a shot of blood thinners to lower the risk. It is generally recommended that patients who are considered high risk continue this when they go home, but it is not done routinely, leading to rates of blood clots still being high. The aim of this study is to see whether giving all patients undergoing colorectal surgery shots at home after surgery is safe and lowers the risk of blood clots.
Who can participate?
Patients undergoing colon and rectal surgery at the division of colorectal surgery at BIDMC
What does the study involve?
All patients are sent home with 30 days of shots of blood thinner from the time of surgery, starting from when they were in the hospital. Patients and family are taught how to do the shots. Visiting nurses also arrange to come to the patients' homes to help with injections and more teaching.
What are the possible benefits and risks of participating?
Participating may decrease the chance of blood clots.
Where is the study run from?
Beth Israel Deaconess Medical Center (BIDMC), Boston, MA (USA)
When is the study starting and how long is it expected to run for?
August 2017 to December 2018
Who is funding the study?
Not funded – this is a quality improvement project, costs of medications and visiting nurses are covered by insurance
Who is the main contact?
Dr Vitaliy Poylin
vitaliy.poylin2@nm.org
Trial website
Contact information
Type
Scientific
Primary contact
Dr Vitaliy Poylin
ORCID ID
http://orcid.org/0000-0002-5814-3915
Contact details
676 North St Clair Street
Suite 650
Chicago
60611
United States of America
+1 (0)312 926 0159
vitaliy.poylin2@nm.org
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
BIDMC 2
Study information
Scientific title
Minimal effect of universal extended prophylaxis on rates of venous thromboembolic events after colorectal surgery in a tertiary care center. Is compliance the problem?
Acronym
Study hypothesis
Extended VTE (venous thromboembolism) prophylaxis is safe after colon and rectal surgery and will decrease overall rates of VTE.
Ethics approval
Approved 11/19/2018, Institutional Review Board at Beth Israel Deaconess Medical Center (330 Brookline Ave., Boston, MA 02115, USA; Email: jripton@bidmc.harvard.edu)
Study design
Prospective quality improvement trial, comparison to historic controls
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Colon and rectal surgery, venous thromboembolism
Intervention
Universal extended (30 days after surgery) prophylaxis with enoxaperin. Enoxaparin dose was weight based and used for 30 days after surgery. Survey was done 30 days after surgery.
Intervention type
Drug
Phase
Not Applicable
Drug names
Enoxaperin
Primary outcome measure
1. Complications from extended use of enoxaparin, measured using chart review and phone interview at 30 days after surgery
2. Compliance with extended prophylaxis regimen, measured using phone survey at 30 days after surgery
Secondary outcome measures
1. Rates of VTE measured using chart review and NSQIP data collection at 30 days after surgery
2. Other complications measured using chart review at 30 days after surgery
Overall trial start date
01/08/2017
Overall trial end date
31/01/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients undergoing colon and rectal surgery at BIDMC between 11/1/2017 and 10/31/2018
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
270
Participant exclusion criteria
1. Patients with contraindication for use of low molecular weight heparin
2. Patients already on anticoagulation for other conditions
Recruitment start date
01/11/2017
Recruitment end date
31/10/2018
Locations
Countries of recruitment
United States of America
Trial participating centre
Beth Israel Deaconess Medical Center
330 Brookline Ave
Boston
02215
United States of America
Sponsor information
Organisation
Beth Israel Deaconess Medical Center
Sponsor details
330 Brookline Ave
Boston
02215
United States of America
+1 (0)617 667 7000
vpoylin@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Submitted to a journal for publication.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Vitaliy Poylin (vitaliy.poylin2@nm.org).
Intention to publish date
01/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list