A randomized double blind placebo controlled trial of MF 701 Dermatan sulphate for prevention of deep vein thrombosis (DVT) in hip fracture

1990 ◽  
Vol 4 ◽  
pp. 80
Author(s):  
G. Agnelli ◽  
B. Cosmi ◽  
M. Longetti ◽  
F. Veschi ◽  
V. Ranucci ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Hip Fracture ◽  
Controlled Trial ◽  
Dermatan Sulphate ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Vein Thrombosis ◽  
Deep Vein

A Randomised, Double-Blind, Placebo-Controlled Trial of Dermatan Sulphate for Prevention of Deep Vein Thrombosis in Hip Fracture

1992 ◽  
Vol 67 (02) ◽  
pp. 203-208 ◽  
Author(s):  
Giancarlo Agnelli ◽  
Benilde Cosmi ◽  
Paolo Di Filippo ◽  
Valeria Ranucci ◽  
Franca Veschi ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Hip Fracture ◽  
Controlled Trial ◽  
Second Phase ◽  
Dermatan Sulphate ◽  
Heparin Cofactor Ii ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Vein Thrombosis ◽  
Deep Vein

SummaryDermatan sulphate (MF 701) is a natural glycosaminoglycan that catalyses thrombin inhibition by heparin cofactor II. The aim of the study was to evaluate the efficacy and safety of MF 701 for prevention of deep vein thrombosis (DVT) in patients with hip fracture. A randomised, double-blind, placebo-controlled design was used to assess two dose regimens of MF 701 in two consecutive study phases. Treatment was started within 48 h from the trauma and continued for 14 days for non-operated patients or until the 10th postoperative day. Bilateral mandatory venography was used to assess the end-point. Eighty patients were included in the first phase (40 MF 701, 40 placebo). MF 701, 100 mg IM b. i. d., did not reduce incidence of DVT from that on placebo and did not induce any bleeding. In the second phase 126 patients were included, with a randomisation ratio of 2:1 (84 MF 701, 300 mg IM b.i.d., 42 placebo). Bilateral venography was obtained for 110 patients. The incidence of DVT was 64% (23/36) in the placebo group and 38% (28/74) in the MF 701 group (p = 0.01; odds ratio [OR] = 0.34, 95% confidence limits [CL] = 0.15-0.80); proximal DVTs were 42% (15/36) and 20% (15/74), respectively (p = 0.02; OR = 0.36, CL = 0.15-0.89). No significant differences were found in haemorrhagic complications (2.4% in each group), blood loss from drains, blood transfusions, haemoglobin and haematocrit values. This study is the first demonstration that dermatan sulphate is a clinically effective antithrombotic agent without bleeding effects. It also provides evidence of the biological role of heparin cofactor II.

scholarly journals Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial

2016 ◽  
Vol 3 (12) ◽  
pp. e556-e562 ◽  
Author(s):  
Marc Righini ◽  
Jean-Philippe Galanaud ◽  
Hervé Guenneguez ◽  
Dominique Brisot ◽  
Antoine Diard ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Anticoagulant Therapy ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Vein Thrombosis ◽  
Deep Vein

scholarly journals Evaluating the Role of Compression Stockings in Preventing Post thrombotic Syndrome: A Review of the Literature

Thrombosis ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Abir O. Kanaan ◽  
Jayne E. Lepage ◽  
Shabdis Djazayeri ◽  
Jennifer L. Donovan
Keyword(s):  
Risk Factors ◽  
Controlled Trial ◽  
Postthrombotic Syndrome ◽  
Review Of The Literature ◽  
Compression Stockings ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Vein Thrombosis ◽  
Deep Vein

Background. Postthrombotic syndrome (PTS) is a burdensome and costly complication of deep vein thrombosis (DVT). Up to 50% of patients with DVT will develop the disease within two years following the diagnosis of acute DVT. Various risk factors for developing PTS have been identified and different modalities have been used to prevent its development. Compression stockings have been studied for the prevention of PTS in patients diagnosed with proximal DVT. Methods. MEDLINE and EMBASE databases were searched to identify relevant original articles. Results. Several trials including two metaanalyses have examined the role of compression stockings for the prevention of PTS. Although most trials showed significant reduction in the development of PTS with the use of compression stockings, limitations in study design prevent the generalizability of the data. Two studies supported an individualized tailored duration especially in patients at low risk for developing the syndrome. A randomized double-blind placebo-controlled trial involving 800 patients is currently ongoing and may confirm the results of older studies. Conclusions. Clinical trials support the use of compression stockings in patients diagnosed with proximal DVT for the prevention of PTS.

An Assessment Of Subcutaneous Ancrod In Prevention Of Deep Vein Thrombosis After Surgery For Hip Replacement

1981 ◽  
Vol 46 (01) ◽  
pp. 093-093
Author(s):  
J Belch ◽  
D Meek ◽  
G Lowe ◽  
M Drummond ◽  
A Campbell ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Hip Replacement ◽  
Controlled Trial ◽  
Placebo Patient ◽  
Post Mortem ◽  
Double Blind ◽  
Subcutaneous Injections ◽  
Vein Thrombosis ◽  
High Incidence ◽  
Deep Vein

There is a high incidence of deep vein thrombosis (DVT) and pulmonary embolism (PTE) amongst patients undergoing surgery for hip replacement. We have assessed the use of ancrod (Arvin), a de- fibrinating enzyme in the prophylaxis of DVT.In a randomised double-blind controlled trial 35 patients received daily subcutaneous injections of ancrod after operation for hip replacement and 38 patients received saline injections. DVT was detected by bilateral ascending venography (68 patients) or post-mortem (1 patient) 7-19 days after surgery. The frequency of major femoral DVT (> 5 cm long) was significantly reduced from 18 thrombi in the limbs of the placebo group to 5 in the ancrod group ( p<0.05). Major bilateral femoral DVT were similarly reduced from 7 to 1 patients by treatment with ancrod.The overall frequency of all thrombi, including calf DVT, was however not significantly different between the groups. 5 patients had evidence of PTE (3 placebo, 2 ancrod). 6 patients within the ancrod group had evidence of increased wound bleeding, compared with one placebo patient, but in only one patient was this considered severe enough to require cessation of ancrod injections. As the majority of PTE perhaps arise from large femoral thrombi it would seem that ancrod prophylaxis, by reducing thrombus size, could aid the reduction of PTE in this group of patients.

A Double-Blind Trial of Intramuscular Stanozolol in the Prevention of Postoperative Deep Vein Thrombosis Following Elective Abdominal Surgery

1984 ◽  
Vol 51 (01) ◽  
pp. 071-074 ◽  
Author(s):  
S L Blarney ◽  
B M McArdle ◽  
P Burns ◽  
D C Carter ◽  
G D O Lowe ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Placebo Group ◽  
Controlled Trial ◽  
Double Blind Trial ◽  
Double Blind ◽  
Vein Thrombosis ◽  
Postoperative Deep Vein Thrombosis ◽  
Deep Vein ◽  
To Receive

SummaryFibrinolytic shutdown may be important in the development of postoperative deep vein thrombosis (DVT). We have previously shown that stanozolol 50 mg, given intramuscularly 24 hr before surgery, prevents the decrease in plasminogen activator activity (PA) seen on the first postoperative day in patients at high risk of DVT. To investigate the role of fibrinolytic shutdown in causation of DVT, sixty patients were randomised in a double-blind controlled trial to receive stanozolol or placebo intramuscularly, and DVT was detected by leg scanning and confirmed by venography. Scan positive DVT occurred in IT of 31 placebo patients (35%) and 12 of 29 who received stanozolol (41%). A significant decrease in PA was confirmed in the placebo group, while stanozolol caused a significant increase in PA on the first postoperative day. Patients in either group who did not develop DVT showed minimal changes in PA. We conclude that prevention of fibrinolytic shutdown by this regimen of stanozolol does not prevent postoperative DVT, and that further studies are required to clarify the relationships of postoperative fibrinolysis and DVT.

Acute Deep Vein Thrombosis Treated with Porcine Plasmin

1974 ◽  
Vol 32 (02/03) ◽  
pp. 468-482 ◽  
Author(s):  
O Storm ◽  
P Ollendorff ◽  
E Drewsen ◽  
P Tang
Keyword(s):  
Deep Vein Thrombosis ◽  
Lower Limb ◽  
Initial Dose ◽  
Treated Group ◽  
Allergic Reactions ◽  
Double Blind ◽  
Vein Thrombosis ◽  
Thrombolytic Effect ◽  
Acute Deep Vein Thrombosis ◽  
Deep Vein

SummaryThe thrombolytic effect of pig plasmin was tested in a double blind trial on patients with deep venous thrombosis in the lower limb. Only patients with not more than three days old thrombi were selected for this study. The diagnosis of deep vein thrombosis was made clinically and confirmed by phlebography. Lysofibrin Novo (porcine plasmin) or placebo (porcine plasminogen) was administered intravenously to the patients. The enzyme and the placebo were delivered as lyophilized powder in labelled bottles - the contents of the bottles were unknown to the doctor in charge of the clinical administration of the trial. An initial dose of plasmin/plasminogen of 30 unit per kg body weight given slowly intravenously (1-1% hours infusion) was followed by a maintenance dosis of 15 per cent the initial dose per hour for the following 5-7 hours. In most cases a similar maintenance dosis was given the next day. In all patients heparin was administered after ending the plasmin/plasminogen infusion. The results of the treatment was evaluated clinically as well as by control phlebo- grams the following days.A statistically significant improvement was found in the plasmin treated group compared with the placebo (plasminogen) treated group. Thrombolysis was obtained clinically and phlebographically in 65 per cent of the plasmin treated group, but only in 15 per cent of the control patients were improvements found.This study has thus demonstrated that plasmin treatment according to a standard scheme was able to induce thrombolysis. There were only a few and insignificant side effects. Allergic reactions have not been seen and only very simple tests are required.

Controlled Trial of the Sequential Use of Streptokinase and Ancrod in the Treatment of Deep Vein Thrombosis of Lower Limb

1977 ◽  
Vol 37 (02) ◽  
pp. 222-232 ◽  
Author(s):  
D. A Tibbutt ◽  
C. N Chesterman ◽  
E. W Williams ◽  
T Faulkner ◽  
A. A Sharp
Keyword(s):  
Deep Vein Thrombosis ◽  
Clinical Improvement ◽  
Anticoagulant Therapy ◽  
Lower Limb ◽  
Oral Anticoagulant ◽  
Controlled Trial ◽  
Oral Anticoagulant Therapy ◽  
Control Group ◽  
Vein Thrombosis ◽  
Deep Vein

SummaryTreatment with streptokinase (‘Kabikinase’) was given to 26 patients with venographically confirmed deep vein thrombosis extending into the popliteal vein or above. Treatment was continued for 4 days and the patients were allocated randomly to oral anticoagulant therapy or a course of treatment with ancrod (‘Arvin’) for 6 days followed by oral anticoagulant therapy. The degree of thrombolysis as judged by further venographic examination at 10 days was not significantly different between the 2 groups. The majority of patients showed clinical improvement but there was no appreciable difference between the groups at 3 and 6 months. Haemorrhagic complications were a more serious problem during the period of treatment with ancrod than during the equivalent period in the control group.

Trial of Aspirin and RA 233 in Prevention of Post-operative Deep Vein Thrombosis

1973 ◽  
Vol 30 (01) ◽  
pp. 018-024 ◽  
Author(s):  
Edward H. Wood ◽  
Colin R.M. Prentice ◽  
D. Angus McGrouther ◽  
John Sinclair ◽  
George P. McNicol
Keyword(s):  
Deep Vein Thrombosis ◽  
Controlled Trial ◽  
Oral Anticoagulants ◽  
Antithrombotic Agent ◽  
Fractured Neck Of Femur ◽  
Neck Of Femur ◽  
Vein Thrombosis ◽  
Effective Prophylaxis ◽  
Deep Vein ◽  
Calf Vein

SummaryAlthough the oral anticoagulants provide effective prophylaxis against postoperative deep vein thrombosis following fracture of neck of femur there is a need for an antithrombotic agent which needs less laboratory control and does not cause haemorrhagic complications. It has been suggested that drugs causing inhibition of platelet function may fulfil these requirements. A controlled trial was carried out in which aspirin, RA 233, or a combination of these drugs was compared with a placebo in the prevention of post-operative deep vein thrombosis. In thirty patients undergoing surgery for fractured neck of femur the incidence of post-operative calf vein thrombosis, as detected by 125I-fibrinogen scanning, was not significantly different between the untreated and treated groups.

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