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A randomized double blind placebo controlled trial of MF 701 Dermatan sulphate for prevention of deep vein thrombosis (DVT) in hip fracture
199 A randomized double blind placebo controlled trial of MF 701 Dermatan sulphate for prevention of deep vein thrombosis (DVT) in hip fracture AGNELLI G, COSMI B, LONGETTIM, VESCHI F, RANUCCI V RENGA C, “DI FILIPPO p, *RINONAPOLI R, **BARZI F, **LUPAlTELLI L, NENCI GG, ***GLANESE F Institutes of Semeiotica Medica, *Ortopedia and **Radiologia, Universityof Perugia; ***Mediolanum Farmaceutic( Milan, Ita@ The aim of the study was to evaluate the efficacy and safety of MF 701 dermatan sulfate in the prevention of DVT in hip fracture, using mandatory venography to assess the endpoint. 126 consecutive patients were included in a double blind trial comparing MF 701, 300 mg IM b.i.d., to placebo
Predicting failure of low-dose heparin prophylaxis in general surgery WILLE-J@RGENSEN P, OTTP Depament of surgical gastroenterologyD, Herlev Hospital, Universityof Copenhagen, Denmark Despite the use of low-dose heparin (LDH), postoperative thromboembolism (TE) is found in 10% of patients undergoing abdominal surgery. To identify predictors of TE in spite of LDH, 171 general surgical patients receiving LDH were screened with fibrinogen uptake test. Diagnosis of TE was confirmed by either venography and/or pulmonary scintigraphy or autopsy. As analyzed by multiple logistic regression, only age, body mass index, preoperative hemoglobin concentration and colorectal surgery (yes/no) contributed to the prediction of failure of LDH, whereas sex, malignancy, previous TE, hypertension, diabetes mellitus and varicose veins did not. Based on the first 81 patients, an index, I, was
201 Low doses of heparin and heparin dihydergot in postoperative thromboembolic protection of gynecologic patients URLEP-SALINOVlC V JELATANCEVB, NIKOLIC T General Hospital Maribor, Maribor, Yugoslavia In a randomized, prospective comparative study of postoperative thromboembolic protection 500 gynecologic patients were included. The patients were either over 40 years of age, or younger with multiple risk factors. In the first group 255 (51%) patients aged 26-84 (51211) were receiving 5000 IU on Na-heparin (Galenika) twice a day subcutaneously, with the initial dose two hours prior to surgery. In the second group 245 (49%) patients aged 34-86 (53klO) were receiving heparin dihydergot (5000 IU Na-heparin + 0.5 mg dihydroergotamine mesylate, Sandoz), given in the same way. Both groups were quite similar and comparable
(P) IM b.i.d. Randomization ratio was 2:l (84 MF 701,42 P). Treatment was started within 36 hours from the trauma and continued for 14 days in non-operated patients (n= 12) or until the 10th postoperative day (n=114). A bilateral venography was obtained in 110 patients (74 MF 701,36 P) at the end of the treatment or when serially performed impedance plethysmography became positive. DVT incidence was 64% (23/36) in the P group and 38% (28/74) in the MF 701 group (p=O.O2); proximal DVTs were 42% (S/36) and 20% (15/74) respectively (p=O.O3). One case of pulmonary embolism and two deaths occurred in the P group. No significant differences were found in haemorrhagic complications (2.4% in each group), blood loss from drains, intraand postoperative blood transfusions, haemoglobin and haematocrit values. MF 701 reduced total and proximal DVT incidence by 41% and 51% respectively, without inducing any significant bleeding effect.
constructed that was able to identify 11 of 13 patients with TE and exclude 34 of 68 without TE. Tested on a second series of 90 patients it correctly identified 10 of 11 patients with TE and excluded 40 of 79 patients without TE. It is concluded that by the use of the index it is possible to identify a group of patients undergoing general surgery, in which LDH is not a sufficient prophylaxis. I = -0.96 + 1.98 X C 0.222 x Hb + 0.0784 x BMI + 0.0326 x Age, where: C: Colorectal surgery = 1, all other surgery = 0, Hb: Preoperative hemoglobin in grammes pr deciliter, BMI: Weight in kilograms/(Height in meters)2, Age: Age in years.
in respect to risk factors. Deep vein thrombosis (DVT) was detected by l”-I fibrinogen test. Pulmonary embolism (PE) was detected clinically and confirmed by X-ray and lung perfusion scintigraphy. In the first group 26 (10.2%) patients developed thromboembolic disease, 23 (9%) as DVT and 3 (1.2%) as PE. In the second group thromboembolic disease developed in 23 patients, in 22 (8.8%) as DVT and in 1 (0.2%) as PE. PE were significantly reduced (~~0.05) by heparin dihydergot protection. Hematomas at the wound site developed in 8 (3.1%) patients in the first and in 9 (3.7%) patients in the second group. Adverse effects like decreases in the platelet counts or vasospasms were not found.
Predicting failure of low-dose heparin prophylaxis in general surgery WILLE-J@RGENSEN P, OTTP Depament of surgical gastroenterologyD, Herlev Hospital, Universityof Copenhagen, Denmark Despite the use of low-dose heparin (LDH), postoperative thromboembolism (TE) is found in 10% of patients undergoing abdominal surgery. To identify predictors of TE in spite of LDH, 171 general surgical patients receiving LDH were screened with fibrinogen uptake test. Diagnosis of TE was confirmed by either venography and/or pulmonary scintigraphy or autopsy. As analyzed by multiple logistic regression, only age, body mass index, preoperative hemoglobin concentration and colorectal surgery (yes/no) contributed to the prediction of failure of LDH, whereas sex, malignancy, previous TE, hypertension, diabetes mellitus and varicose veins did not. Based on the first 81 patients, an index, I, was
201 Low doses of heparin and heparin dihydergot in postoperative thromboembolic protection of gynecologic patients URLEP-SALINOVlC V JELATANCEVB, NIKOLIC T General Hospital Maribor, Maribor, Yugoslavia In a randomized, prospective comparative study of postoperative thromboembolic protection 500 gynecologic patients were included. The patients were either over 40 years of age, or younger with multiple risk factors. In the first group 255 (51%) patients aged 26-84 (51211) were receiving 5000 IU on Na-heparin (Galenika) twice a day subcutaneously, with the initial dose two hours prior to surgery. In the second group 245 (49%) patients aged 34-86 (53klO) were receiving heparin dihydergot (5000 IU Na-heparin + 0.5 mg dihydroergotamine mesylate, Sandoz), given in the same way. Both groups were quite similar and comparable
(P) IM b.i.d. Randomization ratio was 2:l (84 MF 701,42 P). Treatment was started within 36 hours from the trauma and continued for 14 days in non-operated patients (n= 12) or until the 10th postoperative day (n=114). A bilateral venography was obtained in 110 patients (74 MF 701,36 P) at the end of the treatment or when serially performed impedance plethysmography became positive. DVT incidence was 64% (23/36) in the P group and 38% (28/74) in the MF 701 group (p=O.O2); proximal DVTs were 42% (S/36) and 20% (15/74) respectively (p=O.O3). One case of pulmonary embolism and two deaths occurred in the P group. No significant differences were found in haemorrhagic complications (2.4% in each group), blood loss from drains, intraand postoperative blood transfusions, haemoglobin and haematocrit values. MF 701 reduced total and proximal DVT incidence by 41% and 51% respectively, without inducing any significant bleeding effect.
constructed that was able to identify 11 of 13 patients with TE and exclude 34 of 68 without TE. Tested on a second series of 90 patients it correctly identified 10 of 11 patients with TE and excluded 40 of 79 patients without TE. It is concluded that by the use of the index it is possible to identify a group of patients undergoing general surgery, in which LDH is not a sufficient prophylaxis. I = -0.96 + 1.98 X C 0.222 x Hb + 0.0784 x BMI + 0.0326 x Age, where: C: Colorectal surgery = 1, all other surgery = 0, Hb: Preoperative hemoglobin in grammes pr deciliter, BMI: Weight in kilograms/(Height in meters)2, Age: Age in years.
in respect to risk factors. Deep vein thrombosis (DVT) was detected by l”-I fibrinogen test. Pulmonary embolism (PE) was detected clinically and confirmed by X-ray and lung perfusion scintigraphy. In the first group 26 (10.2%) patients developed thromboembolic disease, 23 (9%) as DVT and 3 (1.2%) as PE. In the second group thromboembolic disease developed in 23 patients, in 22 (8.8%) as DVT and in 1 (0.2%) as PE. PE were significantly reduced (~~0.05) by heparin dihydergot protection. Hematomas at the wound site developed in 8 (3.1%) patients in the first and in 9 (3.7%) patients in the second group. Adverse effects like decreases in the platelet counts or vasospasms were not found.