Efficacy and Safety of a Low‐Molecular‐Weight Heparin and Standard Unfractionated Heparin for Prophylaxis of Postoperative Venous Thromboembolism: European Multicenter Trial

Abstract

A randomized, double-blind multicenter trial was performed to compare the safety and efficacy of a new low-molecular-weight heparin (LMWH) (LU 47311, Clivarine) and standard unfractionated heparin for the prophylaxis of postoperative venous thromboembolism. Altogether 1351 patients scheduled to undergo abdominal surgery were included. Main outcome measures included the incidence of thromboembolic events (deep vein thrombosis, pulmonary embolism, or both) and bleeding complications, including wound hematoma. A total of 655 patients received 1750 anti-Xa IU of LMWH plus a placebo injection daily; 677 patients received 5000 IU of unfractionated heparin (UFH) twice a day. Both drugs were found to be equally effective, as 4.7% of patients in the LMWH group and 4.3% in the UFH group developed postoperative thromboembolic complications. However, the incidence of bleeding complications was significantly reduced in the LMWH group: 55 (8.3%) patients in the LMWH group and 80 (11.8%) in the UFH group developed bleeding complications, a relative risk (RR) of 0.70 (95% CI 0.51-0.97;p = 0.03); wound hematoma occurred in 29 (4.4%) of the LMWH group compared with 55 (7.7%) in those in the UFH group for an RR of 0.57 (95% CI 0.37-0.88;p = 0.01). This study confirmed that a very low dose of 1750 anti-Xa IU daily of this new LMWH is as effective as 10,000 IU of UFH for preventing postoperative deep vein thrombosis. At this dose its administration is associated with a significant reduction in the risk of bleeding including wound hematoma.

Low-molecular-weight heparin administered by subcutaneous catheter is a safe and effective anti-coagulation regimen in selected inpatient infants and children with complex congenital heart disease

“…7,9 In contrast, there is a large body of evidence that therapeutic levels were reached faster and less monitoring was necessary in patients receiving low-molecular-weight heparin for anti-coagulation. 14,22,[31][32][33][34][35][36] In order to achieve optimal therapeutic levels, dosing of low-molecular-weight heparin needs to be adjusted to age and weight of children since dosing guidelines for adult patients cannot be transferred to children. 3,8,17,20 There were no serious complications including stroke, thrombotic events, or significant bleeding requiring intervention or causing permanent disability in the current study.…”

“…Similar low rates of thrombotic 6,20,37 or bleeding 4,38,39 complications are reported in other studies investigating the use of low-molecular-weight heparin in the children for different indications. 18,33,[40][41][42] Superiority in efficacy, safety, and costs of low-molecular-weight heparin therapy compared with continuous-infusion unfractionated heparin for initiation of anti-coagulation after mechanical prosthetic valve implantation has been shown in adults. 43 Injection pain and anxiety pose additional physical and psychological stress on complex CHD children requiring numerous hospitalisations and interventions during early life and childhood.…”

Efficacy and Safety of Enoxaparin for Preventing Venous Thromboembolic Events following Urologic Laparoscopic Surgery

“…Moreover, the occurrence of spinal epidural hematoma when using enoxaparin with epidural or spinal anesthesia was reported [20], but enoxaparin has a reduced risk of heparin-induced thrombocytopenia and hemorrhagic complications, severe bleeding, or wound hematomas compared with LDUH in large RCTs [21, 22]. Because our data from hematological examinations and clinical observations indicate that coagulability was not excessively affected by enoxaparin, we propose that this treatment is safe and efficacious without the need for laboratory monitoring of patients when appropriately used.…”

Low molecular weight heparin in prophylaxis of deep vein thrombosis in Asian general surgical patients: A Kashmir experience

“…Various studies have found LMWH to be effective as UH in the prevention of DVT, but in view of its more convenient way of administration and overall risk benefit ratio, they advocated that LMWHs might be preferred over UH for DVT prophylaxis. [151920]…”