Effects of prolonged anti blood clot treatment after colorectal surgery
| ISRCTN | ISRCTN74314169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74314169 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | BIDMC 2 |
| Sponsor | Beth Israel Deaconess Medical Center |
| Funder | Investigator initiated and funded |
- 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
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
Scientific
676 North St Clair Street
Suite 650
Chicago
60611
United States of America
 ORCID ID |
0000-0002-5814-3915 |
|---|---|
| Phone | +1 (0)312 926 0159 |
| vitaliy.poylin2@nm.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective quality improvement trial, comparison to historic controls |
| Secondary study design | Non randomised study |
| 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? |
| Study objectives | Extended 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) studied | 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 / device / biological / vaccine name(s) | Enoxaperin |
| Primary outcome measure(s) |
1. Complications from extended use of enoxaparin, measured using chart review and phone interview at 30 days after surgery |
| Key secondary outcome measure(s) |
1. Rates of VTE measured using chart review and NSQIP data collection at 30 days after surgery |
| Completion date | 31/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | All |
| Target sample size at registration | 270 |
| Total final enrolment | 270 |
| Key inclusion criteria | All patients undergoing colon and rectal surgery at BIDMC between 11/1/2017 and 10/31/2018 |
| Key exclusion criteria | 1. Patients with contraindication for use of low molecular weight heparin 2. Patients already on anticoagulation for other conditions |
| Date of first enrolment | 01/11/2017 |
| Date of final enrolment | 31/10/2018 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Boston
02215
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | 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). |
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.
