A DOUBLE BLIND RANDOMIZED TRIAL OF ORG 10172 LOW MOLECULAR WEIGHT HEPARINOID IN THE PREVENTION OF DEEP VEIN THROMBOSIS IN PATIENTS WITH THROMBOTIC STROKE

1987 ◽  
Author(s):  
A G G Turple ◽  
M N Levin ◽  
J Hirish ◽  
C J Carter ◽  
R M Jay ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Deep Vein Thrombosis ◽  
Placebo Group ◽  
Venous Thrombosis ◽  
Randomized Trial ◽  
Thrombosis Prophylaxis ◽  
Low Molecular Weight ◽  
Double Blind ◽  
Vein Thrombosis ◽  
Deep Vein

The optimal method of venous thrombosis prophylaxis in patients with stroke is uncertain. ORG 10172 is a low molecular weight heparinoid consisting principally of heparan and dermatan sulphates. In animal studies, ORG 10172 is as effective as unfractionated heparin in preventing venous thrombosis but produces less bleeding. There have been a limited number of descriptive studies on its use in humans, but to date randomized efficacy trials of ORG 10172 in the prevention of venous thrombosis have not been reported. A double blind randomized trial was carried out to compare ORG 10172 with placebo in the prevention of deep vein thrombosis in patients with thrombotic stroke. Seventy-five patients were randomized to receive ORG 10172 (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). Prophylaxis was commenced within 7 days of stroke onset, continued for 14 days or until discharge from hospital, if earlier. Venous thrombosis surveillance was carried out with 125-1 fibrinogen leg scanning and impedance plethysmography. Venous thrombosis was confirmed by venography which occurred in 2 of 50 (4%) in the ORG 10172 group and 7 of 25 (28%) in the placebo group (p=0.005). The corresponding rates for proximal 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. The anti-factor Xa levels (units/ml; mean ± SE) gradually rose from 0.18 ± 0.001 and 0.06 ± 0.01 six and 12 hours after injection on the first day to 0.24 ± 0.02 and 0.12 ± 0.01 after 11 days treatment. The results of this study indicate that ORG 10172 heparinoid is effective prophylaxis against deep vein thrombosis in patients with acute thrombotic stroke.

DEEP VEIN THROMBOSIS PROPHYLAXIS IN SURGICALLY TREATED FRACTURED HIP PATIENTS

1987 ◽  
Author(s):  
P J Powers ◽  
M Gent ◽  
R Jay ◽  
J Hirsh ◽  
M Levine ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Placebo Group ◽  
Venous Thrombosis ◽  
Major Complication ◽  
Lower Limbs ◽  
Thrombosis Prophylaxis ◽  
Double Blind ◽  
Vein Thrombosis ◽  
Warfarin Group ◽  
Deep Vein

Deep vein thrombosis is a major complication in'patients treated surgically for fractured hip. Methods employed toreduce the risk of thrombosis include dextran, ASA, warfarin, low or adjusted dose heparin and calf compression, but none has widespread acceptance.A randomized trial wascarried out to assess the effectiveness of sodium warfarinand acetyl salicylic acid(aspirin) compared to placebo inthe prevention of venous thrombosis in fractured hip patients. One hundred and ninty four patients were randomizedto receive warfarin (65 patients), ASA (66 patients) or placebo (63 patients).Prophylaxis commenced post operatively and continued for 21 days or until discharge, if earlier.Warfarin patients received 10 mg sodium warfarin orally as soon as possible after surgery. Warfarin was then given daily according to the prothrombin time (PT), to obtain a PT of 16 seconds on the 5th post operative day. The PT was maintain at 16 to 18 seconds until the end of treatment.ASA and placebo patients received enteric coated tablets, 650 mg twice daily, in a double blind fashion beginning as soon as possible post operatively and continuingto the end of treatment. Surveillance testing and I-fibrinogen leg scanning and impedance plethysmography was performed and venography was done if either test suggested thrombus at the popliteal vein or above. Otherwise venography was performed at day 21 or prior to discharge, if earlier. Venous thrombosis occurred in 13 patients (20%) in the warfarin group, 27 patients (^0.9%) in the ASA group, and 29 patients (46%) in the placebo group (P=0.005). Proximal vein thrombosis or pulmonary embolism occurred in 6patients (9.2%) in the warfarin group,7 patients (10.6%) in the ASA and 19 patients (30.2%) in the placebo group (P=0.002). Two major hemorrhages occurred in the warfarin group, none in the ASA group, and 2 in the placebo group.The results of this study show sodium warfarin to be safeand effective in reducing thromboembolic complications infractured hip patients and ASA to be effective in reducing thrombosis involving the proximal deep veins of the lower limbs in these patients.

A RANDOMIZED, DOUBLE BLIND STUDY OF A LOW MOLECULAR WEIGHT HEPARIN (KABI 2165) ONCE DAILY AND LOW DOSE STANDARD HEPARIN TWICE DAILY, IN THE PREVENTION OF POST OPERATIVE DEEP VEIN THROMBOSIS IN GENERAL SURGERY. A French Multicenter Trial

1987 ◽  
Keyword(s):  
Molecular Weight ◽  
Deep Vein Thrombosis ◽  
Low Molecular Weight Heparin ◽  
Low Dose ◽  
Multicenter Trial ◽  
Low Molecular Weight ◽  
Double Blind ◽  
Once Daily ◽  
Vein Thrombosis ◽  
Deep Vein

The efficacy and safety of a low molecular weight heparin (Kabi 2165) in preventing postoperative deep vein thrombosis (D.V.T.), was assessed in a double blind randomly allocated multicenter trial. 385 patients were included and analysed on a intention to treat basis. Kabi 2165 was given S.C. 24 hourly in 2 500 anti-factor Xa units and compared with standard low dose calcium heparin 5 000 i.u. S.C. 12 hourly in patients undergoing major abdominal or gynaecological surgery. The first dose was administered two hours before operation in both groups. The relevant characteristics of the patients in the two treatment groups were similar. The two groups were well matched for risk factors which could predispose to D.V.T.DVT was detected by the radioactive fibrinogen test. Venography was performed whenever a positive scan developed in a patient. Six (3,1 96) of 195 patients receiving Kabi 2165 and seven (3,7 96) of 190 patients in the standard heparin group developed D.V.T. No pulmonary embolism we re detected during the prophylactic regimens. There was no significant difference between the two groups in terms of blood loss during surgery, postoperative drainage, blood transfusion, wound haematoma. Mean hemoglobin levels and mean hematocrit values preoperatively and postoperatively (day 1 and 6) were :There were no statistically significant differences in both groups. No thrombocytopenia was reported in this study. The antifactor Xa activity was significantly higher in the Kabi 2165 group.In conclusion, Kabi 2165 once daily is as effective and safe as standard heparin twice daily in preventing postoperative D.V.T. in general surgery.

EFFICACY AND SAFETY OF A LOW MOLECULAR WEIGHT HEPARIN (LMW-HEPARIN SANDOZ) IN PATIENTS WITH DEEP VEIN THROMBOSIS

1987 ◽  
Author(s):  
G Vogel ◽  
M Machulik
Keyword(s):  
Molecular Weight ◽  
Deep Vein Thrombosis ◽  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Low Molecular Weight Heparin ◽  
Low Molecular Weight ◽  
Efficacy And Safety ◽  
Vein Thrombosis ◽  
Complete Lysis ◽  
Deep Vein

28 patients with deep venous thrombosis (DVT) were randomized to low molecular heparin (LMWH) SANDOZ ( Nurnberg, F.R.G.) 3 OOO U/day per infusio-nem during 10 days or to unfractionated heparin(UFH) 30 000 U/day per infusionem during 10 days. Venography was repeated at day 11. of 14 patients given UFH 5 obtained complete lysis, 6 incomplete lysis and 3 no lysis. The differences were not statistically Significant. No haemorrhagic complications were seen in LMWH grouup but 5 large hamtomas were observed in UFH group. The result suggest that LMWH Sandoz and UFH were equally effecetive on thrombus reduction whereas hemorrgic complications were more common with UFH than with LMWH

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