SUBCUTANEOUS ENOXAPARINE (LOVENOXR) VERSUS PLACEBO FOR PREVENTING DEEP VEIN THROMBOSIS (DVT) AFTER TRANSURETHRAL PROSTATECTOMY (TUP)

1987 ◽  
Author(s):  
F LE GAGNEUX ◽  
A STEG ◽  
M LE GUILLOU
Keyword(s):  
Placebo Group ◽  
Low Molecular Weight ◽  
High Dose ◽  
Double Blind Study ◽  
Red Cell ◽  
Transurethral Prostatectomy ◽  
Double Blind ◽  
Vein Thrombosis ◽  
Significant Difference ◽  
Deep Vein

The aim of this study was mainly to evaluate the risk of bleeding, and the efficiency of Enoxaparine, a low-molecular-weight-heparin, in preventing DVT in patients undergoing TUP.89 patients (mean age : 67.5 years + 1.3), undergoing TUP, were included in a randomized, double blind study. Patients with a major risk of thromboembolism were excluded. 44 patients received one daily subcutaneous (SC) injection of 60 mg of Enoxaparine ; 45 patients received placebo. All the patients received the first injection 12 hours before operation.Red cell transfusions requirements were not significantly different between the two groups : 18 % of patients in the Enoxaparine group and 13 % of patients in the placebo group received red cell transfusions (p = 0.57). The amount of red cell units required was 3.3 units ± 0.9 in the Enoxaparine group and 2.5 U ± 0.8 in the placebo group (p = 0.51). The urethral catheters were removed on the 4th post operative day in each group.There was no significant difference in daily hemoglobin levels between the two groups.No DVT occurred : 125I fibrinogen scanning was negative in all patients but two : in these two patients (one in each group), DVT was not confirmed by a radiographic phlebography. No pulmonary embolism occurred.Enoxaparine, begun 12 hours before operation, however injected at high dose (60 mg/24 hrs), is safe in patients undergoing TUP. No significant bleeding complication occurred in the Enoxaparine group comparing with the placebo group. Red cell transfusions requirements were the same in both groups. There was no DVT in our patients.Enoxaparine (LOVENOXR) - PHARMUKA S.F.

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.

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.

Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9007-9007 ◽  
Author(s):  
S. Lee ◽  
S. Lee ◽  
Y. Chun ◽  
M. Kim ◽  
H. Chang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chemotherapy Regimen ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hand Foot Syndrome ◽  
Version 2.0 ◽  
The Mean ◽  
To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

A Randomized Double-Blind Study Between a Low Molecular Weight Heparin Kabi 2165 and Standard Heparin in the Prevention of Deep Vein Thrombosis in General Surgery

1988 ◽  
Vol 59 (02) ◽  
pp. 216-220 ◽  
Author(s):  
J P Caen
Keyword(s):  
Molecular Weight ◽  
General Surgery ◽  
Low Molecular Weight Heparin ◽  
Daily Injection ◽  
Major Surgery ◽  
Low Molecular Weight ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Calcium Heparin

SummaryThe safety and efficacy of a low molecular weight heparin fragment Kabi 2165, given in the dose 2,500 anti-Xa units once daily, in preventing postoperative venous thromboembolism, was assessed against calcium heparin in the dose 5,000 IU twice daily, in a multicenter double blind randomized study. On an intention to treat basis 385 patients scheduled for major surgery were included in this study. Six patients (3.1%) out of 195 developed isotopic DVT in the Kabi 2165 group. Corresponding figures for calcium heparin was 7 patients (3.7%). There was no statistically significant difference between the two groups with respect to the bleeding variables; blood loss during operation, postoperative drainage, blood transfusion, haemoglobin and haematocrit levels; wound haematoma and haematoma at the injection sites. No patient had to undergo evacuation of wound haematoma or reoperation due to bleeding. It is concluded that one single daily injection of Kabi 2165 provides a convenient safe and effective prophylaxis against thromboembolism in general surgery.

Sodium Citrate: An Alternative Antacid for Prophylaxis against Aspiration Pneumonitis

1982 ◽  
Vol 10 (2) ◽  
pp. 116-119 ◽  
Author(s):  
J. Wrobel ◽  
T. C. Koh ◽  
J. M. Saunders
Keyword(s):  
Placebo Group ◽  
Surgical Procedures ◽  
Sodium Citrate ◽  
Gastric Ph ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Gastric Contents ◽  
The Mean ◽  
Induction Of Anaesthesia

In a double-blind study, 107 patients undergoing elective and emergency surgical procedures were given 15 ml of either sodium citrate 0ṁ3 M or placebo 10 minutes before induction of anaesthesia. Gastric contents were sampled immediately after induction and the pH was measured. The mean pH of the gastric contents of patients given sodium citrate was 5ṁ67, whereas for those given the placebo it was 3ṁ21 (p < 0ṁ001). Of patients given sodium citrate 92% had a gastric pH above 3ṁ0 compared with only 37% in the placebo group (p < 0ṁ001). At the end of surgery gastric contents were emptied as completely as possible and the volume and pH measured. There was no significant difference in the mean volume of gastric contents in the two groups. In neither group was the mean pH at the end of surgery significantly different from that after induction.

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