| Title: |
Efficacy and safety of extended duration to perioperative thromboprophylaxis with low molecular weight heparin on disease-free survival after surgical resection of colorectal cancer (PERIOP-01): multicentre, open label, randomised controlled trial |
| Authors: |
Auer, Rebecca C; Ott, Michael; Karanicolas, Paul; Brackstone, Muriel Rebecca; Ashamalla, Shady; Weaver, Joel; Tagalakis, Vicky; Boutros, Marylise; Stotland, Peter; Marulanda, Antonio Caycedo; Moloo, Husein; Jayaraman, Shiva; Patel, Suni; Le Gal, Grégoire; Spadafora, Silvana; MacLellan, Steven; Trottier, Daniel; Jonker, Derek; Asmis, Timothy; Mallick, Ranjeeta; Pecarskie, Amanda; Ramsay, Tim; Carrier, Marc |
| Contributors: |
Canada Foundation for Innovation; Canadian Institutes of Health Research |
| Source: |
BMJ ; volume 378, page e071375 ; ISSN 1756-1833 |
| Publisher Information: |
BMJ |
| Publication Year: |
2022 |
| Description: |
Objective To determine the efficacy and safety of extended duration perioperative thromboprophylaxis by low molecular weight heparin when assessing disease-free survival in patients undergoing resection for colorectal cancer. Design Multicentre, open label, randomised controlled trial. Settings 12 hospitals in Quebec and Ontario, Canada, between 25 October 2011 and 31 December 2020. Participants 614 adults (age ≥18 years) were eligible with pathologically confirmed invasive adenocarcinoma of the colon or rectum, no evidence of metastatic disease, a haemoglobin concentration of ≥8 g/dL, and were scheduled to undergo surgical resection. Interventions Random assignment to extended duration thromboprophylaxis using daily subcutaneous tinzaparin at 4500 IU, beginning at decision to operate and continuing for 56 days postoperatively, compared with in-patient postoperative thromboprophylaxis only. Main outcome measures Primary outcome was disease-free survival at three years, defined as survival without locoregional recurrence, distant metastases, second primary (same cancer), second primary (other cancer), or death. Secondary outcomes included venous thromboembolism, postoperative major bleeding complications, and five year overall survival. Analyses were done in the intention-to-treat population. Results The trial stopped recruitment prematurely after the interim analysis for futility. The primary outcome occurred in 235 (77%) of 307 patients in the extended duration group and in 243 (79%) of 307 patients in the in-hospital thromboprophylaxis group (hazard ratio 1.1, 95% confidence interval 0.90 to 1.33; P=0.4). Postoperative venous thromboembolism occurred in five patients (2%) in the extended duration group and in four patients (1%) in the in-hospital thromboprophylaxis group (P=0.8). Major surgery related bleeding in the first postoperative week was reported in one person ( |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1136/bmj-2022-071375 |
| Availability: |
https://doi.org/10.1136/bmj-2022-071375; http://data.bmj.org/tdm/10.1136/bmj-2022-071375; https://syndication.highwire.org/content/doi/10.1136/bmj-2022-071375 |
| Rights: |
http://creativecommons.org/licenses/by-nc/4.0/ |
| Accession Number: |
edsbas.5161C54 |
| Database: |
BASE |