Clinical studies with low‐molecular‐weight heparin(oid)s: An interim analysis

Cate, Hugo Ten; Henny, C. P.; Cate, J. W. Ten; Büller, Harry R.

doi:10.1002/ajh.2830270217

Cited by 14 publications

(3 citation statements)

References 47 publications

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“…However, this significant risk reduction by heparin was associated with an increase in reported bleeding episodes of approximately 20% (1), and concern about hemorrhagic complications has indeed limited the widespread clinical use of heparin prophylaxis in patients undergoing elective hip surgery (4,5) Recently, low molecular weight heparin(oid)s have been introduced for clinical investigation, based on the premises that they are at least as effective as unfractionated heparin and cause less hemorrhage. So far, several randomized trials in general surgery have shown a greater effectiveness of low molecular weight heparin as compared to standard heparin, with a similar tolerance with regard to bleeding (6)(7)(8)(9). In elective hip surgery one placebo-controlled trial of low molecular weight heparin showed an impressive reduction in the incidence of deep-vein thrombosis from 42 to L2% (9).…”

Section: !Ntroductionmentioning

confidence: 99%

Prevention of Deep Vein Thrombosis following Total Hip Replacement by Low Molecular Weight Heparinoid

et al. 1992

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SummaryWe assessed the safety and efficacy of the novel low molecular weight heparinoid Lomoparan (Org 10172) for the prevention of deep-vein thrombosis in patients undergoing elective total hip replacement in a randomized, placebo-controlled, double-blind trial in 197 consecutive patients. The heparinoid (750 anti-factor Xa-units, s. c., b.i.d.) was administered to 97 patients and 99 patients received placebo. Study medication was started preoperatively and continued for 10 days. Efficacy was assessed by bilateral phlebography at day 10, postoperatively.The incidence of deep-vein thrombosis was 56.6% and 15.5% respectively in the placebo and heparinoid treated patients (incidence reduction: 74%; P <0.001). This reduction was observed both for proximal-vein thrombosis (25% to 8%; P <0.005) and isolated calf-vein thrombosis (31% to 7%; P <0001.No major hemorrhage was observed. The number of red-cell units transfused and drain-fluid loss were comparable for the two study groups. Six patients in the heparinoid group and none in the control group developed minor wound hematomas (P <0.05).During an 8-week post-discharge follow-up period three patients with a normal venogram at day 10 developed clinically apparent venous thromboembolism, which was confirmed by objective testing. All three patients belonged to the heparinoid-treated group.We conclude that 750 anti-factor Xa units Org 10172 s.c. twice daily starting preoperatively is safe and effectively reduces early deep-vein thrombosis following elective total hip replacement. Further studies on the incidence of post-discharge thromboembolism are required.

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Section: !Ntroductionmentioning

confidence: 99%

Prevention of Deep Vein Thrombosis following Total Hip Replacement by Low Molecular Weight Heparinoid

et al. 1992

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“…Recently, an overview on the clinical studies with LMW heparin(oid)s has been published [131]. It was concluded in this analysis that the antithrombotic potential of LMW heparins is comparable to that of heparin, whereas a decreased hemorrhagic potential has not yet been demonstrated.…”

Section: Special Clinical Studies With Lmw Heparinsmentioning

confidence: 99%

Pharmacology and special clinical applications of low‐molecular‐weight heparins

Harenberg

Heene

1988

American J Hematol

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In this overview, the rationale of the development of low-molecular-weight (LMW) heparins and their toxicological, anticoagulant, fibrinolytic, lipolytic, and protamine interactions are summarized. Clinical experiences are reviewed on the benefit of LMW heparin for anticoagulation in patients with bleeding and other complications on conventional anticoagulants and during pregnancy. It is concluded that animal experiments have demonstrated the safety of LMW heparins, that the pharmacologic profile is improved compared with normal heparin, and that the simple and safe applicability of LMW heparins gives rise to new indications for the long-term prophylaxis of thromboembolism.

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“…Low-molecular-weight heparin fractions and heparinoids have been extensively evalu ated and are currently in use in the prevention of thrombo-embolic disease in a number of high-risk groups of patients [5,6]. Orgaran (Org 10172, low-molecular-weight heparinoid) has been shown to be effective in pre venting venous thrombosis in high-risk surgi cal patients without significant bleeding risk [7], Orgaran is a mixture of sulphated glycosaminoglycans derived from animal intestinal mucosa which consists mainly of heparan and dermatan sulphate [8].…”

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confidence: 99%

Orgaran in the Prevention of Deep Vein Thrombosis in Stroke Patients

Turpie¹

1992

Pathophysiol Haemos Thromb

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Venous thrombo-embolism is a common complication in patients with acute ischaemic stroke. Without prophylaxis, deep vein thrombosis occurs in 60-75% of patients with dense hemiplegia, usually in the paralyzed limb, and 1-2% suffer fatal pulmonary embolism. Orgaran (Org 10172, low-molecular-weight heparinoid) has been evaluated for the prevention of deep vein thrombosis in patients with acute ischaemic stroke in two studies. In a double-blind study, 75 patients were randomized to receive Orgaran (50 patients) in a loading dose of 1,000 anti-Xa units intravenously followed by 750 anti-Xa units subcutaneously 12-hourly or placebo (25 patients). Deep vein thrombosis occurred in 2 of 50 (4%) in the Orgaran group and 7 of 25 (28%) in the placebo group (p = 0.005). The corresponding rates for proximal deep vein thrombosis were 0 and 16%, respectively (p = 0.01). There was one major haemorrhage in the treated group and one minor haemorrhage in the placebo group. In the second study, the safety and efficacy of Orgaran was compared with unfractionated heparin in the prevention of deep vein thrombosis in a double-blind randomized trial. Eighty-seven patients with marked lower limb paralysis secondary to stroke were randomized to receive Orgaran (45 patients) in a dose of 750 anti-factor Xa units subcutaneously 12-hourly or unfractionated heparin (42 patients) in a dose of 5,000 units subcutaneously 12-hourly. Venous thrombosis occurred in 4 of 45 (8.9%) of the Orgaran group and 13 of 42 (31%) in the unfractionated heparin group (2p = 0.014). The corresponding rates for proximal vein thrombosis were 4.4 and 11.9%, respectively (2p = 0.255).(ABSTRACT TRUNCATED AT 250 WORDS)

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Clinical studies with low‐molecular‐weight heparin(oid)s: An interim analysis

Cited by 14 publications

References 47 publications

Prevention of Deep Vein Thrombosis following Total Hip Replacement by Low Molecular Weight Heparinoid

Prevention of Deep Vein Thrombosis following Total Hip Replacement by Low Molecular Weight Heparinoid

Pharmacology and special clinical applications of low‐molecular‐weight heparins

Orgaran in the Prevention of Deep Vein Thrombosis in Stroke Patients

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