A Cross-Over Study of a new Low Molecular Weight Heparin (Logiparin®) in Hemodialysis

Abstract

The safety and effectiveness of a low molecular weight heparin (LMWH) of 4500 +/- 1500 Daltons were evaluated in eight hemodialysis (HD) patients, in comparison with unfractionated heparin (UFH). In phase A of the study 3000 +/- 500 anti-factor Xa (AFXa) IU of LMWH were administered in bolus for the three consecutive HD sessions of a week. In phase B, 10000 +/- 2500 IU of UFH were administered to the same patients for the same time. Were observed no significant differences in hematocrit (Ht), platelets (Pt), fibronogen (FG) and prothrombin time (PT). Whole blood activated coagulation time (WBACT) was more prolonged with LMWH, 24 and 48 hours (start of next session) after administration (p < 0.05), and less prolonged at 5, 60, 120, 180, 240 min compared to UFH (p < 0.001). The activated partial thromboplastin time (APTT) and AFXa activity were more prolonged with UFH at 60 and 240 min (p < 0.001). The clinical effectiveness of the two preparations was similar as judged by thrombus formation and compression time. In conclusion, the present study found no real differences between LMWH and UFH, except for prolongation of WBACT 24 and 48 hours after the administration of LWMH. This probably indicates a cumulative effect of the LMWH and needs further investigation.

Safety and Efficacy of Low Molecular Weight Heparins for Hemodialysis in Patients with End-Stage Renal Failure

“…We excluded 114 studies after title and abstract screening using inclusion and exclusion criteria. Of the 33 remaining studies, 15 did not meet the inclusion criteria after article review: 14 studies were not randomized (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25), and one study used a historical control UFH arm (26). One study was excluded because all patients had underlying hypercoagulability (27).…”

Executive summary of the Korean Society of Nephrology 2021 clinical practice guideline for optimal hemodialysis treatment

“…We selected clinical studies with parallel or cross-over designs that randomly allocated patients on HD or HDF into LMWH and UFH groups over a period of at least 1 month. Several studies were excluded from the analysis because of the following reasons: a less-than-1week study period (Borm et al [68], Koutsikos et al [69] in the meta-analysis by Lim et al [66] and Palamaner Subash Shantha et al [67]); a dose-finding study design (Ryan et al [70]); and no random allocation (Al-Saran et al [71], Bramham et al [72], Yang et al [73] in a meta-analysis by Lazrak et al [65], and Sabry et al [74]). A meta-analysis was performed using six studies [75][76][77][78][79][80], although the poor blinding in these studies produced only moderate levels of evidence.…”

Korean Society of Nephrology 2021 Clinical Practice Guideline for Optimal Hemodialysis Treatment

“…We selected clinical studies with parallel or cross-over designs that randomly allocated patients on HD or HDF into LMWH and UFH groups over at least a 1-month period. Based on those criteria, several studies were excluded from our analysis for the following reasons: less than a 1-week study period (Borm et al [82], Koutsikos et al [83] in the meta-analysis by Lim et al [80] and Palamaner Subash Shantha et al [81]); a dose finding study design (Ryan et al [84]); and no random allocation (Al-Saran et al [85], Bramham et al [86], Yang et al [87] in a meta-analysis by Lazrak et al [79], and Sabry et al [88]). Our meta-analysis was thus performed with six studies [89][90][91][92][93][94], though the poor blinding in those studies produced only a moderate level of evidence.…”