The optimal administration regimens of low molecular weight heparins (LMWHs) have not yet been established. The aim of this study was to compare the efficacy and safety of 2500 and 5000 XaI units of the LMWH dalteparin in patients undergoing elective general surgery for malignant and benign abdominal disease. Prophylaxis was started in the evening before surgery and given once-daily every evening thereafter. The study was designed as a prospective, randomized, double-blind, multicentre trial. Some 66.4 per cent of patients were operated on for a malignant disorder. The primary endpoint was deep vein thrombosis (DVT) detected with the fibrinogen uptake test. Bleeding complications were recorded and classified. Analysis was made both on an intention to treat basis and in patients given correct prophylaxis (86.3 per cent). A total of 2097 patients were randomized and 27 excluded after randomization. A technically correct fibrinogen uptake test was obtained in 1957 patients. The incidence of DVT was significantly lower in patients given 5000 XaI units, this being true for both correct prophylaxis (6.8 versus 13.1 per cent, P < 0.001), on an intention to treat basis (6.6 versus 12.7 per cent, P < 0.001), and in patients with malignant disease (8.5 versus 14.9 per cent, P < 0.001). Sixty-seven patients (3.2 per cent) died within 30 days with no difference between the groups. There were two cases of fatal pulmonary embolism. The frequency of bleeding complications in the whole series was higher in patients randomized to 5000 XaI units (4.7 versus 2.7 per cent, P = 0.02), although this was not the case in those operated on for malignant disease (4.6 versus 3.6 per cent, P not significant). Dalteparin in the dose of 5000 XaI units started in the evening before surgery has a good thromboprophylactic effect in high-risk general surgery at the cost of a small bleeding risk. In patients with malignant disease there was no increased risk of bleeding. The overall frequency of fatal pulmonary embolism with dalteparin is extremely low, even in this high-risk group of patients.

Adult↗

PubMed1991

Chronic leg ulcers: an underestimated problem in primary health care among elderly patients.

STUDY OBJECTIVE: The aim was to establish leg ulcer point prevalence, basal patient characteristics, and level of caretaking. DESIGN: The study was a postal cross sectional survey. The validity was ensured by examining a randomly selected sample of reported patients. Responding health care officials were asked to report all patients with an open wound below knee (including foot ulcer) which did not heal or was supposed to heal within a six week period after onset of ulceration. Response rate was 92%. SETTING: Inpatient and outpatient care in hospitals, community health care, and private nursing homes within Skaraborg county, with a population of 270,800. PARTICIPANTS: 827 individual patients were found with active leg ulcers, 526 women and 301 men. MEASUREMENTS AND MAIN RESULTS: Age adjusted sex ratio of ulcer patients was 1:1.4 (M:F). The median age was 78 years for women and 76 for men; 700 patients (85%) were older than 64 years. The point prevalence for active leg ulcers was 3.0/1000 total population. District nurses provided care for 680 patients (82%), 106 (13%) were in hospital care, and 41 (5%) were managed by outpatient departments. CONCLUSIONS: There has been an underestimation of the leg ulcer problem among elderly patients, especially men. With an expected increasing number of elderly people it is important that this problem is recognised and measures taken to improve the primary care of these patients.

Adolescent↗

PubMed1990

Thromboprophylactic effect of low molecular weight heparin started in the evening before elective general abdominal surgery: a comparison with low-dose heparin.

A prospective randomized double-blind trial was performed comparing conventional low-dose heparin with a LMWH fragment (Kabi 2165, Fragmin) for thromboprophylaxis in elective general abdominal surgical patients. The first dose of the fragment was given in the evening before surgery, and thereafter every evening. There were 1002 analyzable patients, 826 having received correct prophylaxis. Sixty three percent of the patients were operated on for malignant diseases. The frequency of DVT was significantly reduced among patients with correct prophylaxis with the heparin fragment (9.2 to 5.0%, p = 0.02). In patients with malignancies the reduction was from 11.2 to 6.4% (p = 0.06). The frequency of bleeding was 6.7% among the heparin fragment patients and 2.7% among the patients given conventional heparin (p = 0.01). The corresponding frequencies for patients with malignancies were 3.2 and 2.8%, respectively (p = 0.28). All bleedings were minor and of no clinical significance. Local pain at the injection site was reported significantly less often among patients with the fragment. Twenty patients died, 13 with malignant disease, mortality being the same in the two groups. It is concluded that heparin fragment administered in the evening before surgery and then every evening is a practically acceptable alternative to prevent postoperative DVT in patients undergoing elective abdominal surgery, also when the histology shows malignancy. Thus, the advantages of using LMWH compared with conventional low-dose heparin are simplified administration routines, better thromboprophylactic effect, and less local pain at injection sites. A disadvantage is the slight increase in hemorrhagic side effects, all of minor clinical importance and not seen in patients undergoing surgery for malignancy.

Abdomen↗

PubMed1988

Low molecular weight heparin given the evening before surgery compared with conventional low-dose heparin in prevention of thrombosis.

A prospective randomized double-blind trial was performed comparing conventional low-dose heparin with a low molecular weight heparin fragment for thromboprophylaxis in elective general abdominal surgical patients. The first dose of the heparin fragment was given the evening before surgery, and further doses were given thereafter every evening. There were 1002 analysable patients, 826 having received correct prophylaxis. Of these 1002 patients, 64 per cent were operated on for malignant disease. A total of 20 patients died, 10 in each group. The frequency of deep vein thrombosis was significantly reduced among patients with correct prophylaxis with the heparin fragment (9.2-5.0 per cent, P = 0.02) [corrected]. The frequency of bleeding was 6.7 per cent among the heparin fragment patients and 2.7 per cent among the patients given conventional heparin (P = 0.01), but all bleeds were of minor degree and there was no difference in the reoperation rate for bleeding, or in the transfusion requirements. Local pain at the injection site was reported significantly less often among patients given the heparin fragment.

Abdomen↗

PubMed1988

Leg ulcer epidemiology.

Explore the source record for details and available documents.

Adult↗

PubMed1987

[Arteriovenous fistula--an unusual complication in resection of the small bowel].

Explore the source record for details and available documents.

Arteriovenous Fistula↗

PubMed1987

Ketanserin in intermittent claudication: effect on walking distance, blood pressure, and cardiovascular complications.

In a 7-center Scandinavian double-blind placebo-controlled study of 179 patients with intermittent claudication, the effect of the serotonin antagonist ketanserin was evaluated on walking distance, brachial and ankle blood pressure, and symptoms. For all centers together, pain-free walking distance was significantly increased after 6 months with both ketanserin (+65%; 71 patients) and placebo (+42%; 78 patients), with no significant difference. However, there was large variability among centers. Classification of "responders" (doubling of walking distance) and patients who deteriorated (decrease of walking distance or dropout for inefficacy) showed significantly more patients responding and significantly fewer patients deteriorating with ketanserin than with placebo. Systemic blood pressure was significantly decreased by ketanserin in hypertensive, but not normotensive, patients, while ankle pressure was unaffected. The incidence and nature of side effects were equal with ketanserin and placebo, but there were more side effects causing dropout in the ketanserin group. An unexpected and possibly important observation was the occurrence of six serious cardiovascular events (myocardial infarction, cerebrovascular complications, and development of rest pain) in the placebo group but none in ketanserin-treated patients. Moreover, there were four additional similar complications in the placebo run-in period. Ketanserin appears to be beneficial in a subgroup of patients with intermittent claudication. A fortuitous finding of this study is that ketanserin might possess a protective effect against thrombovascular complications in patients with intermittent claudication.

Adult↗

PubMed1986

Low molecular weight heparin once daily compared with conventional low-dose heparin twice daily. A prospective double-blind multicentre trial on prevention of postoperative thrombosis.

In a randomized, prospective, double-blind multicentre trial, the effect of conventional low-dose heparin 5000 units twice daily, was compared with that of a low molecular weight heparin fragment (4000-5000) 5000 anti-factor Xa units once daily. Four hundred and thirty-two patients fulfilled the inclusion criteria and were analysed for development of deep vein thrombosis (125I-labelled fibrinogen test) and haemorrhagic complications. Thrombosis occurred in a 4.3 per cent of patients in the low-dose heparin group and in 6.4 per cent of patients in the heparin fragment group, a difference which is not significant. There was a significant delay in the onset of thrombosis in the heparin fragment group. Mortality did not differ between the groups, nor did peroperative blood loss or transfusion requirements or infectious complications. Haemorrhagic complications occurred significantly more often in the fragment group (11.6 per cent) than in the conventional heparin group (4.6 per cent). Patients in the heparin fragment group experienced local pain following the subcutaneous injection significantly less often.

Adult↗

PubMed1986

Prospective double-blind comparison between Fragmin and conventional low-dose heparin: thromboprophylactic effect and bleeding complications.

In a randomized, prospective, double-blind multicenter trial, the effect of low-dose conventional heparin (5,000 IU/12 h) was compared to a low molecular weight (LMW) heparin fragment (5,000 antifactor Xa U/24 h). 432 patients 40 years or older undergoing elective abdominal surgery were included, 382 correctly treated. 45% had malignant diseases. The groups did not differ in risk factors. Analysis was made both on the basis of intention to treat and correct prophylaxis. No difference in results between these 2 groups was seen. Deep vein thrombosis (125I-fibrinogen) occurred in 4.3% of the low-dose heparin group and in 6.4 of the LMW heparin group. There was a significant delay in the onset of deep vein thrombosis in the LMW heparin group. Mortality, peroperative blood loss, transfusions or infectious complications did not differ. Hemorrhagic complications occurred significantly more often in the LMW heparin group (11.6%) than in the low-dose heparin group (4.6%). Significantly fewer patients experienced local injection pain in the LMW heparin group. APTT and AT III were similar in both groups, but anti-Xa activity was significantly higher in the LMW heparin group. Single daily LMW heparin injection reduced the frequency of deep vein thrombosis to the same level as low-dose heparin twice daily. The dose or administration interval of LMW heparin in this study caused significantly more bleeding complications.

Aged↗

PubMed1986

Late venous function in the leg after deep venous thrombosis occurring in relation to pregnancy.

The frequency of deep venous insufficiency was investigated in 23 patients 3-10 years (mean 7 years) after they had developed an objectively diagnosed deep venous thrombosis (DVT) during pregnancy or the first week after delivery. Investigations included clinical examination, listing of symptoms and plethysmography, venous pressure and Doppler ultrasound. At follow-up there were clinical signs or symptoms of venous insufficiency in 35% of the legs with earlier DVT but in none of the non-thrombosed contralateral legs. Objective evidence of venous insufficiency was present in 15 (65%) of the legs with earlier DVT and in only five (22%) of the non-thrombosed legs. The differences between thrombosed and non-thrombosed legs are statistically significant. There was no correlation between objectively measured venous insufficiency and extent of the DVT. It is concluded that a DVT during pregnancy often leads to venous insufficiency and the risk seems to be higher than after DVT occurring in other groups of patients.

Adolescent↗