Biomaterial Database

[Comparative study of defibrotide and calcium heparin in the prevention of postoperative deep venous thrombosis. A randomized multicenter study]. 1988

V Battistel, and A De Rosa

Servizio Medico di Farmacovigilanza, Roussel Maestretti, Milano.

The efficacy and tolerability of defibrotide (800 mg/i.v.) and calcium heparin (15,000 UI/s.c.) in the prophylaxis of post-surgical deep venous thrombosis (DVT) and pulmonary embolism (PE) were compared in a multicentre trial involving 60 Italian surgical institutions (general surgery, obstetrics and gynecology, urology). Total enrollment was 2,250 patients (defibrotide: 1.194; calcium heparin 1.056). According to the protocol, the clinical suspicion of DVT and/or PE led to in-depth diagnostic evaluations (DVT: Doppler ultrasound velocimetry; PE: chest X-rays; ECG, pulmonary scintigraphic scanning). The incidence of post-surgical DVT was similar in the two groups (defibrotide: 8 patients; calcium heparin: 10 patients). A trend towards a lower incidence of DVT in the defibrotide group no PE; calcium heparin: 4 cases (chi 2 = 4.530, p less than 0.05). The local and systemic tolerability of both treatment was excellent. This trial, carried out in routine surgical practice, establishes the profibrinolytic approach to DVT prophylaxis as a sound and effective alternative to the traditional interference with the coagulation cascade.

UI	MeSH Term	Description	Entries
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D011089	Polydeoxyribonucleotides	A group of 13 or more deoxyribonucleotides in which the phosphate residues of each deoxyribonucleotide act as bridges in forming diester linkages between the deoxyribose moieties.	Polydeoxyribonucleotide
D011183	Postoperative Complications	Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery.	Complication, Postoperative,Complications, Postoperative,Postoperative Complication
D011655	Pulmonary Embolism	Blocking of the PULMONARY ARTERY or one of its branches by an EMBOLUS.	Pulmonary Thromboembolism,Thromboembolism, Pulmonary,Embolism, Pulmonary,Embolisms, Pulmonary,Pulmonary Embolisms,Pulmonary Thromboembolisms,Thromboembolisms, Pulmonary
D011897	Random Allocation	A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.	Randomization,Allocation, Random
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D005260	Female		Females
D005343	Fibrinolytic Agents	Fibrinolysin or agents that convert plasminogen to FIBRINOLYSIN.	Antithrombic Drug,Antithrombotic Agent,Antithrombotic Agents,Fibrinolytic Agent,Fibrinolytic Drug,Thrombolytic Agent,Thrombolytic Agents,Thrombolytic Drug,Antithrombic Drugs,Fibrinolytic Drugs,Thrombolytic Drugs,Agent, Antithrombotic,Agent, Fibrinolytic,Agent, Thrombolytic,Agents, Antithrombotic,Drug, Antithrombic,Drug, Fibrinolytic,Drug, Thrombolytic,Drugs, Antithrombic
D006493	Heparin	A highly acidic mucopolysaccharide formed of equal parts of sulfated D-glucosamine and D-glucuronic acid with sulfaminic bridges. The molecular weight ranges from six to twenty thousand. Heparin occurs in and is obtained from liver, lung, mast cells, etc., of vertebrates. Its function is unknown, but it is used to prevent blood clotting in vivo and vitro, in the form of many different salts.	Heparinic Acid,alpha-Heparin,Heparin Sodium,Liquaemin,Sodium Heparin,Unfractionated Heparin,Heparin, Sodium,Heparin, Unfractionated,alpha Heparin