Danaparoid-sodium/heparin

SummaryComparative plasma heparin levels were measured in normal subjects injected subcutaneously with 5,000 units of the sodium and calcium salts of heparin. Plasma heparin levels were measured up to 7 hr post-injection by an anti-factor Xa assay (Denson and Bonnar 1973). Preliminary studies indicated that heparin levels were reproducible in subjects who received two injections of the same heparin. Peak plasma concentrations (Cmax) and the time at which peak concentration was reached (Tmax) varied greatly from subject to subject. In one group of subjects (15) two commonly used heparins, a sodium heparin (Evans) and a calcium heparin (Choay) were compared. Peak heparin concentrations were not significantly different. However the Tmax for the sodium heparin (1.5 hr) was significantly earlier than the Tmax for the calcium heparin (3 hr) and this was not due to a difference in the volume of the two heparin injections. No significant difference could be detected in the plasma clearance rate and the molecular weight distribution of the two heparins.In two other groups of subjects, sodium and calcium preparations from two manufacturers were compared. In general, the sodium salts gave rise to significantly higher plasma concentrations, which could be interpreted as a greater bioavailability of sodium salts. These results indicate that the salt of the heparin can influence the plasma concentration achieved after subcutaneous injection.

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Subcutaneous Recombinant Hirudin (HBW 023) Versus Intravenous Sodium Heparin in Treatment of Established Acute Deep Vein Thrombosis of the Legs: a Multicentre Prospective Dose-ranging Randomized Trial

Thrombosis and Haemostasis ◽

10.1055/s-0038-1656063 ◽

1997 ◽

Vol 77 (05) ◽

pp. 0834-0838 ◽

Cited By ~ 59

Author(s):

François Schiele ◽

Folke Lindgaerde ◽

Henry Eriksson ◽

Jean-Pierre Bassand ◽

Anders Wallmark ◽

...

Keyword(s):

Bleeding Complications ◽

Recombinant Hirudin ◽

Serious Adverse Events ◽

Sodium Heparin ◽

Efficacy Analysis ◽

Vein Thrombosis ◽

Dose Ranging ◽

Acute Deep Vein Thrombosis ◽

Deep Vein ◽

Intravenous Sodium

SummaryThe aim of this multicentre, prospective, randomised, dose-ranging study was to compare the safety and efficacy of subcutaneous recombinant hirudin (HBW 023) against intravenous sodium heparin in acute lower limb deep venous thrombosis (DVT). Patients were randomized to treatment with either HBW 023 or heparin for 5 ±1 days. HBW 023 was given according to body-weight in three dose groups. Thromboembolic disease was assessed by phlebography and ventilation/perfusion (V/Q) scanning on Bay 1 and Day 5±1. One hundred and fifty-five patients were enrolled, of these 121 were evaluable for efficacy analysis. Significantly fewer patients on HBW 023 developed new V/Q abnormalities during the treatment period, (p = 0.006). There was no difference between the groups in thrombus extension or regression, major bleeding complications or serious adverse events. There were significantly fewer findings of new V/Q mismatch after treatment with HBW 023, and anticoagulant control was superior in these patients.

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PREVENTING VENOUS THROMBOSIS (VT) WITH HEPARIN ALONE OR WITH HEPARIN/DIHYDROERGOTAMINE AFTER ELECTIVE HIP REPLACEMENT, A DOUBLE-BLIND, RANDOMISED, VENOGRAM END-POINT COMPARISON

10.1055/s-0038-1643687 ◽

1987 ◽

Author(s):

J F Cade ◽

K W Mills ◽

A S Gallus ◽

W Murphy

Keyword(s):

Venous Thrombosis ◽

General Surgery ◽

Hip Replacement ◽

Low Dose ◽

Double Blind ◽

Randomised Study ◽

Sodium Heparin ◽

End Point ◽

Small Doses

Dihydro-ergotaraine (DHE) appears to be synergistic with small doses of hepari when used to prevent VT after general surgery. However, doubt remains whether DHEhas this effect in patients with elective hip replacement (THR). We have therefore compared the results of VT prophylaxis using sub-cutaneous (sc) low-dose heparinalone or sc heparin plus sc DHE in a double-blind, randomised, study of 126 patientshaving elective THR, 98 at centre (1)and 28 at centre (2).All received 5000 iu sodium heparin, hourly for 7 days, starting 2 hours before surgery at centre (1), or immediately after surgery at centre (2). Patients alsoreceived a separate 0.5 ml (0.5 mg) DHEorplacebo injection each time they receivedheparin. Patients had bilateral ascendingvenography on the 7th postoperativeday, and venograms were read before the treatment code was broken.These results do not support the presence of synergism between heparin and DHE in this situation.

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