Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM‐Line): A two‐center open‐label pilot randomized controlled trial
Abstract Background Central venous catheter (CVC) insertion is an important risk factor for venous thromboembolism (VTE) among patients with cancer. Routine use of primary thromboprophylaxis in this patient population is not currently recommended. We sought to assess the feasibility of conducting a...
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| Format: | Article |
| Language: | English |
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Elsevier
2021-05-01
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| Series: | Research and Practice in Thrombosis and Haemostasis |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/rth2.12517 |
| _version_ | 1797724435580452864 |
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| author | Rick Ikesaka Deborah Siegal Ranjeeta Mallick Tzu‐Fei Wang Deborah Witham Carolyn Webb Marc Carrier for the Canadian Venous Thromboembolism Research Network (CanVECTOR) |
| author_facet | Rick Ikesaka Deborah Siegal Ranjeeta Mallick Tzu‐Fei Wang Deborah Witham Carolyn Webb Marc Carrier for the Canadian Venous Thromboembolism Research Network (CanVECTOR) |
| author_sort | Rick Ikesaka |
| collection | DOAJ |
| description | Abstract Background Central venous catheter (CVC) insertion is an important risk factor for venous thromboembolism (VTE) among patients with cancer. Routine use of primary thromboprophylaxis in this patient population is not currently recommended. We sought to assess the feasibility of conducting a randomized controlled trial (RCT) assessing the safety and efficacy of rivaroxaban (10 mg daily) to prevent VTE complications in this patient population. Methods This is a two‐center prospective, randomized, open blinded end point pilot trial including patients with active cancer and a newly inserted CVC. Patients were randomly assigned 1:1 to rivaroxaban or observation for 90 days. The primary feasibility outcome of this pilot study was the number of participants recruited per month. Secondary clinical outcomes included thrombotic complications, major VTE, and major bleeding episodes. Results Overall, 105 patients were enrolled over 11 months. The average enrollment rates were 7.5 and 2 patients per month at the two participating centers, respectively. Overall, thrombotic complications occurred in 3 patients in the rivaroxaban group (5.8%; 95% confidence interval [CI], 1.2‐16.0) compared with 5 patients in the control group (9.4%; 95% CI, 3.1‐20.7) (HR, 0.58; 95% CI, 0.14‐2.5). Major VTE occurred in 2 (3.9%; 95% CI, 0.5‐13.2) and 3 (5.7%; 95% CI, 1.2‐15.7) patients in the rivaroxaban and control group, respectively (HR, 0.66; 95% CI, 0.11‐3.9). One patient (1.9%) receiving rivaroxaban had a major bleeding event. Conclusions Thrombotic complications are common in patients with cancer and a newly inserted CVC. The pilot trial achieved its enrollment targets and supports that a large multicenter RCT is feasible in this area. ClinicalTrials.gov (NCT03506815). |
| first_indexed | 2024-03-12T10:17:12Z |
| format | Article |
| id | doaj.art-e864d694b9554427b9b2ce59c0172700 |
| institution | Directory Open Access Journal |
| issn | 2475-0379 |
| language | English |
| last_indexed | 2024-03-12T10:17:12Z |
| publishDate | 2021-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Research and Practice in Thrombosis and Haemostasis |
| spelling | doaj.art-e864d694b9554427b9b2ce59c01727002023-09-02T10:24:44ZengElsevierResearch and Practice in Thrombosis and Haemostasis2475-03792021-05-0154n/an/a10.1002/rth2.12517Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM‐Line): A two‐center open‐label pilot randomized controlled trialRick Ikesaka0Deborah Siegal1Ranjeeta Mallick2Tzu‐Fei Wang3Deborah Witham4Carolyn Webb5Marc Carrier6for the Canadian Venous Thromboembolism Research Network (CanVECTOR)Department of Medicine McMaster University Hamilton ON CanadaDepartment of Medicine Ottawa Hospital Research InstituteUniversity of Ottawa Ottawa ON CanadaClinical Epidemiology Program Ottawa Hospital Research Institute Ottawa ON CanadaDepartment of Medicine Ottawa Hospital Research InstituteUniversity of Ottawa Ottawa ON CanadaDepartment of Medicine Ottawa Hospital Research InstituteUniversity of Ottawa Ottawa ON CanadaDepartment of Medicine McMaster University Hamilton ON CanadaDepartment of Medicine Ottawa Hospital Research InstituteUniversity of Ottawa Ottawa ON CanadaAbstract Background Central venous catheter (CVC) insertion is an important risk factor for venous thromboembolism (VTE) among patients with cancer. Routine use of primary thromboprophylaxis in this patient population is not currently recommended. We sought to assess the feasibility of conducting a randomized controlled trial (RCT) assessing the safety and efficacy of rivaroxaban (10 mg daily) to prevent VTE complications in this patient population. Methods This is a two‐center prospective, randomized, open blinded end point pilot trial including patients with active cancer and a newly inserted CVC. Patients were randomly assigned 1:1 to rivaroxaban or observation for 90 days. The primary feasibility outcome of this pilot study was the number of participants recruited per month. Secondary clinical outcomes included thrombotic complications, major VTE, and major bleeding episodes. Results Overall, 105 patients were enrolled over 11 months. The average enrollment rates were 7.5 and 2 patients per month at the two participating centers, respectively. Overall, thrombotic complications occurred in 3 patients in the rivaroxaban group (5.8%; 95% confidence interval [CI], 1.2‐16.0) compared with 5 patients in the control group (9.4%; 95% CI, 3.1‐20.7) (HR, 0.58; 95% CI, 0.14‐2.5). Major VTE occurred in 2 (3.9%; 95% CI, 0.5‐13.2) and 3 (5.7%; 95% CI, 1.2‐15.7) patients in the rivaroxaban and control group, respectively (HR, 0.66; 95% CI, 0.11‐3.9). One patient (1.9%) receiving rivaroxaban had a major bleeding event. Conclusions Thrombotic complications are common in patients with cancer and a newly inserted CVC. The pilot trial achieved its enrollment targets and supports that a large multicenter RCT is feasible in this area. ClinicalTrials.gov (NCT03506815).https://doi.org/10.1002/rth2.12517hemorrhageneoplasiarivaroxabanvenous thromboembolismvenous thrombosis |
| spellingShingle | Rick Ikesaka Deborah Siegal Ranjeeta Mallick Tzu‐Fei Wang Deborah Witham Carolyn Webb Marc Carrier for the Canadian Venous Thromboembolism Research Network (CanVECTOR) Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM‐Line): A two‐center open‐label pilot randomized controlled trial Research and Practice in Thrombosis and Haemostasis hemorrhage neoplasia rivaroxaban venous thromboembolism venous thrombosis |
| title | Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM‐Line): A two‐center open‐label pilot randomized controlled trial |
| title_full | Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM‐Line): A two‐center open‐label pilot randomized controlled trial |
| title_fullStr | Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM‐Line): A two‐center open‐label pilot randomized controlled trial |
| title_full_unstemmed | Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM‐Line): A two‐center open‐label pilot randomized controlled trial |
| title_short | Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM‐Line): A two‐center open‐label pilot randomized controlled trial |
| title_sort | thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines trim line a two center open label pilot randomized controlled trial |
| topic | hemorrhage neoplasia rivaroxaban venous thromboembolism venous thrombosis |
| url | https://doi.org/10.1002/rth2.12517 |
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