Dataset Information

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.

ABSTRACT:

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 (<1%) in the extended duration and in six people (2%) in the in-hospital thromboprophylaxis group (P=0.1). No difference was noted for overall survival at five years in 272 (89%) patients in the extended duration group and 280 (91%) patients in the in-hospital thromboprophylaxis group (hazard ratio 1.12; 95% confidence interval 0.72 to 1.76; P=0.1).

Conclusions

Extended duration to perioperative anticoagulation with tinzaparin did not improve disease-free survival or overall survival in patients with colorectal cancer undergoing surgical resection compared with in-patient postoperative thromboprophylaxis alone. The incidences of venous thromboembolism and postoperative major bleeding were low and similar between groups.

Trial registration

ClinicalTrials.gov NCT01455831.

SUBMITTER: Auer RC

PROVIDER: S-EPMC9468899 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Auer Rebecca C RC Ott Michael M Karanicolas Paul P Brackstone Muriel Rebecca MR Ashamalla Shady S Weaver Joel J Tagalakis Vicky V Boutros Marylise M Stotland Peter P Marulanda Antonio Caycedo AC Moloo Husein H Jayaraman Shiva S Patel Suni S Le Gal Grégoire G Spadafora Silvana S MacLellan Steven S Trottier Daniel D Jonker Derek D Asmis Timothy T Mallick Ranjeeta R Pecarskie Amanda A Ramsay Tim T Carrier Marc M

BMJ (Clinical research ed.) 20220913

<h4>Objective</h4>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.<h4>Design</h4>Multicentre, open label, randomised controlled trial.<h4>Settings</h4>12 hospitals in Quebec and Ontario, Canada, between 25 October 2011 and 31 December 2020.<h4>Participants</h4>614 adults (age ≥18 years) were eligible with pathologically confirmed i ...[more]

PMID: 36100263

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Project description:BackgroundAlthough guidelines recommend the use of perioperative chemical thromboprophylaxis for antireflux surgery, the optimal timing for its initiation is unknown. The aim of this study was to investigate whether perioperative timing of chemical thromboprophylaxis affects bleeding, symptomatic venous thromboembolism, and complication rates in patients undergoing antireflux surgery.MethodsThis study involved analysis of prospectively maintained databases and medical records of all elective antireflux surgeries in 36 hospitals across Australia over 10 years.ResultsOverall, chemical thromboprophylaxis was given early (before surgery or intraoperatively) in 1099 (25.6 per cent) patients, and after surgery in 3202 (74.4 per cent) patients, with comparable exposure doses between the two groups. Symptomatic venous thromboembolism risk was unrelated to chemical thromboprophylaxis timing (0.5 versus 0.6 per cent for early and postoperative chemical thromboprophylaxis respectively (odds ratio (OR) 0.97, 95 per cent c.i. 0.41 to 2.47, P = 1.000). Postoperative bleeding developed in 34 (0.8 per cent) patients, and 781 intraoperative adverse events were identified in 544 (12.6 per cent) patients. Both intraoperative bleeding and complications were associated with significantly higher postoperative morbidity affecting multiple organ systems. Importantly, compared with postoperative chemical thromboprophylaxis, early administration increased the risk of postoperative bleeding ((1.5 versus 0.5 per cent for early and postoperative chemical thromboprophylaxis respectively (OR 2.94, 95 per cent c.i. 1.48 to 5.84, P = 0.002)) and intraoperative adverse events ((16.1 versus 11.5 per cent for early and postoperative chemical thromboprophylaxis respectively (OR 1.48, 95 per cent c.i. 1.22 to 1.80, P < 0.001)), as well as independently predicted their occurrences.ConclusionIntraoperative adverse events and bleeding that occur during and after antireflux surgery are associated with significant morbidity. Compared with postoperative chemical thromboprophylaxis, early initiation of chemical thromboprophylaxis confers a significantly higher risk of intraoperative bleeding complications, without appreciable additional protection from symptomatic venous thromboembolism. Therefore, postoperative chemical thromboprophylaxis should be recommended for patients undergoing antireflux surgery.

Project description:BackgroundPatients hospitalised with COVID-19 are at risk for thrombotic events after discharge; the role of extended thromboprophylaxis in this population is unknown.MethodsIn this open-label, multicentre, randomised trial conducted at 14 centres in Brazil, patients hospitalised with COVID-19 at increased risk for venous thromboembolism (International Medical Prevention Registry on Venous Thromboembolism [IMPROVE] venous thromboembolism [VTE] score of ≥4 or 2-3 with a D-dimer >500 ng/mL) were randomly assigned (1:1) to receive, at hospital discharge, rivaroxaban 10 mg/day or no anticoagulation for 35 days. The primary efficacy outcome in an intention-to-treat analysis was a composite of symptomatic or fatal venous thromboembolism, asymptomatic venous thromboembolism on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and cardiovascular death at day 35. Adjudication was blinded. The primary safety outcome was major bleeding. The primary and safety analyses were carried out in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT04662684.FindingsFrom Oct 8, 2020, to June 29, 2021, 997 patients were screened. Of these patients, 677 did not meet eligibility criteria; the remaining 320 patients were enrolled and randomly assigned to receive rivaroxaban (n=160 [50%]) or no anticoagulation (n=160 [50%]). All patients received thromboprophylaxis with standard doses of heparin during hospitalisation. 165 (52%) patients were in the intensive care unit while hospitalised. 197 (62%) patients had an IMPROVE score of 2-3 and elevated D-dimer levels and 121 (38%) had a score of 4 or more. Two patients (one in each group) were lost to follow-up due to withdrawal of consent and not included in the intention-to-treat primary analysis. The primary efficacy outcome occurred in five (3%) of 159 patients assigned to rivaroxaban and 15 (9%) of 159 patients assigned to no anticoagulation (relative risk 0·33, 95% CI 0·12-0·90; p=0·0293). No major bleeding occurred in either study group. Allergic reactions occurred in two (1%) patients in the rivaroxaban group.InterpretationIn patients at high risk discharged after hospitalisation due to COVID-19, thromboprophylaxis with rivaroxaban 10 mg/day for 35 days improved clinical outcomes compared with no extended thromboprophylaxis.FundingBayer.

Dataset Information

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.

Objective

Design

Settings

Participants

Interventions

Main outcome measures

Results

Conclusions

Trial registration

Publications

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.

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