Condition category
Surgery
Date applied
03/07/2019
Date assigned
10/07/2019
Last edited
10/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

01/12/2018

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

Publication citations

Additional files

Editorial Notes

08/07/2019: Trial's existence confirmed by Institutional Review Board.