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Randomized Phase II trial of Enoxiaparin Sodium for the Prevension of Postoperative Venous Thromboembolism after Laparoscopic Colorectal Cancer Surgery (ENVELOPE study)

ABSTRACT: Interventions: Enoxaparin group Subcutaneous injection of enoxaparin 2000U twice daily (postoperative day 2 to discharge) Intermittent pneumatic compression (IPC) prophylaxis (after surgery to postoperative day 1) Control group IPC prophylaxis alone (after surgery to postoperative day 1) Primary outcome(s): Incidence of venos thromboembolism until postoperative day 28 Study Design: Parallel Randomized

DISEASE(S): Colon Cancer

PROVIDER: 2633931 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Recurrent venous thromboembolism (VTE) occurs infrequently following a provoked event but occurs in up to 30% of individuals following an initial unprovoked event. We studied 134 patients with VTE separated into 3 groups: (1) âlow-riskâ patients had â¥1 provoked VTE; (2) âmoderate-riskâ patients had no more than 1 unprovoked VTE; (3) âhigh-riskâ patients had â¥2 unprovoked VTE. 44 individuals with no history of VTE were enrolled as healthy controls. Consented individuals were enrolled at 4 medical centers in the US. Total RNA from whole blood was isolated and hybridized to Illumina HT-12 V4 Beadchips to assay whole genome expression. Using class prediction analysis, we distinguished high-risk patients from healthy controls with good receiver operating curve characteristics (AUC=0.88). We also distinguished high-risk from low-risk individuals, moderate-risk individuals from healthy controls, and low-risk individuals from healthy controls with AUCâs of 0.72, 0.77 and 0.72, respectively. Using differential expression analysis, we identified genes relevant to coagulation, immune response and vascular biology, such as SELP and CD46, which were differentially expressed in at least two comparisons. Neither approach distinguished the moderate-risk patients from the high-risk or low-risk groups. Gene expression profiles may provide insights into biological mechanisms associated with patients at risk for recurrent VTE. Prospective studies are needed to validate these findings. This study includes a total of 218 samples/individuals (in 5 groups; APS, high-risk VTE, moderate-risk VTE, low-risk VTE and healthy-controls). Samples in which the percent of probes present was 15% or less (n=51) were excluded leaving 167 samples. The data for these 167 samples were normalized together. However, this record represents the 132 individual samples in the following groups; high-risk (n=40); moderate-risk (n=33); low-risk (n=34); and healthy controls (n=25). The 35 samples in APS group are represented in GSE48001.

Dataset Information

Randomized Phase II trial of Enoxiaparin Sodium for the Prevension of Postoperative Venous Thromboembolism after Laparoscopic Colorectal Cancer Surgery (ENVELOPE study)

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