Prophylaxis of Thromboembolism in Bariatric Surgery with Parnaparin

Forestieri, Pietro; Quarto, Gennaro; Caterina, Maurizio De; Cuocolo, Alberto; Pilone, Vincenzo; Formato, Andrea; Ruocco, Anna; Ferrari, P

doi:10.1007/s11695-007-9259-z

Cited by 17 publications

(10 citation statements)

References 22 publications

(19 reference statements)

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“…In a study of 66 patients undergoing surgery for severe obesity, Imberti and colleagues showed that a fixed prophylactic dose of parnaparin (4,250 IU/day) was able to achieve prophylactic anti-Xa levels in 98.3 % of patients, while a higher dosage (6,400 IU/day) was associated with excessive anti-Xa levels in 62.3 % of patients [26]. Forestieri and co-workers demonstrated in a small series of ten severely obese patients (BMI >50 kg/m 2 ) that doses of both 4,250 and 6,400 IU/day of parnaparin may provide effective prophylaxis for VTE in the peri-operative period; the authors speculated that higher doses, which may be associated with higher rates of bleeding complications, would offer no real improvement in efficacy [27]. In the non-randomised study by Simone and colleagues, patients undergoing laparoscopic bariatric surgery received enoxaparin 40 or 60 mg every 12 h [28].…”

Section: Discussionmentioning

confidence: 99%

Prophylaxis of Venous Thromboembolism with Low Molecular Weight Heparin in Bariatric Surgery: a Prospective, Randomised Pilot Study Evaluating Two Doses of Parnaparin (BAFLUX Study)

Imberti

Baldini

Giorgi‐Pierfranceschi

et al. 2013

OBES SURG

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BackgroundThe optimal dose of low molecular weight heparin (LMWH) to prevent venous thromboembolism (VTE) after bariatric surgery remains controversial. The aim of this multicentre, open-label, pilot study was to evaluate the efficacy and safety of two different doses of the LMWH parnaparin administered to patients undergoing bariatric surgery.MethodsPatients were randomised to receive 4,250 IU/day (group A) or 6,400 IU/day (group B) of parnaparin s.c. for 7–11 days. Bilateral colour Doppler ultrasound of the lower limb was performed before surgery and at the end of the treatment period. The primary efficacy outcome was a composite of asymptomatic and symptomatic deep vein thrombosis, symptomatic pulmonary embolism and death from any cause during treatment. The primary safety endpoint was major and clinically relevant non-major bleeding.ResultsA total of 258 patients underwent randomization; 8 subjects were excluded following the safety analysis. One hundred thirty-one patients [106 females; mean age, 40.3 years (standard deviation (SD) ±9.6); mean body mass index (BMI), 44.6 kg/m2 (SD ±5.4)] were assigned to group A and 119 patients [93 females; mean age, 41.5 years (SD ±9.9); mean BMI, 44.2 kg/m2 (SD ±5.4)] were assigned to group B. The rate of the primary efficacy outcome was 1.5 % (two cases; 95 % confidence interval (CI), 0.2–6.0 %) in group A as compared with 0.8 % (one case; 95 % CI, 0.4–5.3 %) in group B (p = ns). The composite incidence of major bleeding and clinically relevant non-major bleeding was 6.1 % (eight cases; 95 % CI, 2.9–12.1 %) in group A and 5.0 % (six cases; 95 % CI, 2.1–11.1 %) in group B (p = ns).ConclusionsA parnaparin dose of 4,250 IU/day seems suitable for VTE prevention in patients undergoing bariatric surgery.

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Section: Discussionmentioning

confidence: 99%

Prophylaxis of Venous Thromboembolism with Low Molecular Weight Heparin in Bariatric Surgery: a Prospective, Randomised Pilot Study Evaluating Two Doses of Parnaparin (BAFLUX Study)

Imberti

Baldini

Giorgi‐Pierfranceschi

et al. 2013

OBES SURG

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“…Some authors have advocated empirically increasing the dose of prophylactic LMWH in morbidly obese patients [10,16,18,22] while others, including the authors of the 2008 American College of Chest Physicians (ACCP), highlight the available data, including the data in bariatric surgery patients, and recommend weight-based dosing of LMWHs in obese patients based on actual body weight [23]. Unfortunately, these guidelines do not provide specific dosing regimens.…”

Section: Discussionmentioning

confidence: 99%

Weight-based dosing of enoxaparin for VTE prophylaxis in morbidly obese, medically-Ill patients

Rondina

Wheeler

Rodgers

et al. 2010

Thrombosis Research

138

106

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Introduction In clinical trials, fixed-dose enoxaparin (40 mg once daily) reduces the risk of venous thromboembolism (VTE) in medically-ill patients. However, morbidly obese patients were under-represented in these trials and using fixed-dose enoxaparin in obese patients may be inadequate. We completed a pharmacokinetic study in morbidly obese, medically-ill patients to determine if weight-based dosing of enoxaparin for VTE prophylaxis was feasible, without excessive levels of anticoagulation, as determined by peak anti-Xa levels. Materials and Methods Twenty eight morbidly obese (BMI≥35 kg/m2) patients were enrolled and completed the study protocol. Enoxaparin 0.5 mg/kg was administered once daily subcutaneously and peak anti-Xa levels were measured approximately 4–6 hours after the enoxaparin dose. Results and Conclusions Overall, 46% of patients were female, the average age (±SD) was 54 (±11) years, and the average weight and BMI were 135.6 kg (±25.3) and 48.1 kg/m2 (±11.1), respectively. The average daily dose of enoxaparin was 67 mg (±12). The average peak anti-Xa level was 0.25 (SD±0.11, range 0.08 to 0.59) units/mL. Peak anti-Xa levels did not significantly correlate with weight or BMI. There were no bleeding events, symptomatic VTE, or significant thrombocytopenia. In morbidly obese, medically-ill patients, use of weight-based enoxaparin dosed at 0.5 mg/kg once daily is feasible and results in peak anti-Xa levels within or near recommended range for thromboprophylaxis, without any evidence of excessive anti-Xa activity. These data suggest that this weight-based regimen may be more effective than standard fixed-dose enoxaparin. Clinical outcome studies are warranted to determine the clinical safety and efficacy of this regimen.

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“…Although few data are available for morbidly obese patients, the prophylactic range of AFXa activities for VTE prophylaxis in such patients is expected to lie between 0.2 and 0.5 IU/ml [9].…”

Section: Discussionmentioning

confidence: 99%

Effect of Prophylactic Dalteparin on Anti-factor Xa Levels in Morbidly Obese Patients After Bariatric Surgery

2008

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Prophylaxis of Thromboembolism in Bariatric Surgery with Parnaparin

Cited by 17 publications

References 22 publications

Prophylaxis of Venous Thromboembolism with Low Molecular Weight Heparin in Bariatric Surgery: a Prospective, Randomised Pilot Study Evaluating Two Doses of Parnaparin (BAFLUX Study)

Prophylaxis of Venous Thromboembolism with Low Molecular Weight Heparin in Bariatric Surgery: a Prospective, Randomised Pilot Study Evaluating Two Doses of Parnaparin (BAFLUX Study)

Weight-based dosing of enoxaparin for VTE prophylaxis in morbidly obese, medically-Ill patients

Effect of Prophylactic Dalteparin on Anti-factor Xa Levels in Morbidly Obese Patients After Bariatric Surgery

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