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Detection and Prevention of Post-Operative Deep Vein Thrombosis [DVT] Using Nadroparin Among Patients Undergoing Major Abdominal Operations in India; a Randomised Controlled Trial.

ABSTRACT: Deep vein thrombosis [DVT] is one of the most dreaded complications in post-operative patients as it is associated with considerable morbidity and mortality. Majority of patients with postoperative DVT are asymptomatic. The pulmonary embolism, which is seen in 10% of the cases with proximal DVT, may be fatal. Therefore it becomes imperative to prevent DVT rather than to diagnose and treat. Only one randomized trial has been reported from India to assess the effectiveness of low molecular weight heparin in preventing post-operative DVT. To assess the risk of DVT in North Indian patients following major abdominal operations and to evaluate the effectiveness of Nadroparin, A Low Molecular Weight Heparin (LMWH) therapy in preventing post-operative DVT. Sixty five patients were randomised preoperatively into Group-I; Nadroparin prophylaxis and Group-II: No prophylaxis. The primary outcome was the occurrence of DVT, diagnosed by bilateral lower limb venogram performed, seven to ten days after operation. Secondary outcome measures included adverse effects of radio-opaque dye, intra-operative blood loss, operating time, postoperative platelet count, intraoperative blood transfusion requirements and the total duration of postoperative bed rest. No case of DVT occurred in either group. There was no statistical difference in the risk of secondary outcome measures in the two groups. DVT was not observed in any of the patients, even with several high risk factors indicating a possible protective mechanism in the North Indian population.

SUBMITTER: Murugesan A

PROVIDER: S-EPMC3002774 | biostudies-other | 2010 Aug

REPOSITORIES: biostudies-other

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Project description:BackgroundDeep vein thrombosis (DVT) is a common complication in cancer. Although thromboprophylaxis in cancer patients is recommended by the guidelines, clinicians' use of thromboprophylaxis remains limited due to cost, bleeding complications, and reluctance to give injectable anticoagulants. Inflammation plays essential roles in the pathogenesis of cancer-associated thrombosis. Owing to its ability to decrease proinflammatory cytokines, statins have anti-inflammatory properties. Thus, statins can be possibly utilized as thromboprophylaxis therapy in cancer patients undergoing chemotherapy.ObjectiveTo compare the effectiveness of atorvastatin and rivaroxaban for DVT prevention in high-risk thrombosis patients with cancer undergoing chemotherapy.MethodsDouble-blind, randomized controlled trial involving cancer patients with high-risk of thrombosis undergoing chemotherapy. We randomly assigned patients without deep-vein thrombosis at screening to receive atorvastatin 20 mg or rivaroxaban 10 mg daily for up to 90 days. Doppler ultrasonography was performed 90 days following chemotherapy to diagnose DVT. Average cost-effectiveness analysis was performed to analyze the cost of atorvastatin compared to rivaroxaban.ResultsOf the eighty six patients who underwent randomization, primary efficacy end point was observed in 1 of 42 patients (2.3%) in the atorvastatin group and in 1 of 44 (2.2%) in the rivaroxaban group (Odds Ratio [OR], 0.953; 95% confidence interval [CI], 0.240 to 3.971; p = 1.000). There was a significant difference in the incidence of major bleeding, 2 of 42 patients (4.8%) in the atorvastatin group and 12 of 44 (27.3%) in the rivaroxaban group (OR, 0.257; 95% CI, 0.07 to 0.94; p = 0.007). The average cost-effectiveness ratio of using atorvastatin was lower than that of rivaroxaban.ConclusionAtorvastatin did not differ significantly from rivaroxaban in reducing the incidence of DVT, lower bleeding risk, and cost-effectiveness for thromboprophylaxis in high-risk thrombosis patients with cancer undergoing chemotherapy. The presence of limited statistical power and wide confidence intervals in this study needs further study to strengthen the efficacy of atorvastatin as DVT prophylaxis in cancer patients.Trial registrationISRCTN71891829, Registration Date: 17/12/2020.

Dataset Information

Detection and Prevention of Post-Operative Deep Vein Thrombosis [DVT] Using Nadroparin Among Patients Undergoing Major Abdominal Operations in India; a Randomised Controlled Trial.

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