Effects of prolonged anti blood clot treatment after colorectal surgery

ISRCTN ISRCTN74314169
DOI https://doi.org/10.1186/ISRCTN74314169
Secondary identifying numbers BIDMC 2
Submission date
03/07/2019
Registration date
10/07/2019
Last edited
09/02/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Vitaliy Poylin
Scientific

676 North St Clair Street
Suite 650
Chicago
60611
United States of America

ORCiD logoORCID ID 0000-0002-5814-3915
Phone +1 (0)312 926 0159
Email vitaliy.poylin2@nm.org

Study information

Study designProspective quality improvement trial, comparison to historic controls
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Scientific titleMinimal effect of universal extended prophylaxis on rates of venous thromboembolic events after colorectal surgery in a tertiary care center. Is compliance the problem?
Study objectivesExtended VTE (venous thromboembolism) prophylaxis is safe after colon and rectal surgery and will decrease overall rates of VTE.
Ethics approval(s)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)
Health condition(s) or problem(s) studiedColon and rectal surgery, venous thromboembolism
InterventionUniversal 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Enoxaperin
Primary outcome measure1. 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 measures1. 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 study start date01/08/2017
Completion date31/01/2019

Eligibility

Participant type(s)Patient
Age groupAll
SexBoth
Target number of participants270
Total final enrolment270
Key inclusion criteriaAll patients undergoing colon and rectal surgery at BIDMC between 11/1/2017 and 10/31/2018
Key exclusion criteria1. Patients with contraindication for use of low molecular weight heparin
2. Patients already on anticoagulation for other conditions
Date of first enrolment01/11/2017
Date of final enrolment31/10/2018

Locations

Countries of recruitment

  • United States of America

Study participating centre

Beth Israel Deaconess Medical Center
330 Brookline Ave
Boston
02215
United States of America

Sponsor information

Beth Israel Deaconess Medical Center
Hospital/treatment centre

330 Brookline Ave
Boston
02215
United States of America

Phone +1 (0)617 667 7000
Email vpoylin@gmail.com
ROR logo "ROR" https://ror.org/04drvxt59

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planSubmitted to a journal for publication.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Vitaliy Poylin (vitaliy.poylin2@nm.org).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2021 09/02/2021 Yes No

Editorial Notes

09/02/2021: Publication reference and total final enrolment added.
09/12/2019: The overall end date was changed from 01/12/2018 to 31/01/2019.
08/07/2019: Trial's existence confirmed by Institutional Review Board.