NOVEL TOPICAL QUICK PENETRATING SOLUTION OF HEPARIN IN MANAGEMENT OF SUPERFICIAL THROMBOPHLEBITIS: RESULTS OF RANDOMIZED ACTIVE CONTROLLED TRIALAbstract
Aim: To compare safety and efficacy of topical quick penetrating solution (QPS) of heparin 1000 IU/ml versus heparin gel 200 IU/g in the management of post infusion superficial thrombophlebitis.
Methods: Total 202 patients of early, medium and advance stage ofsuperficial thrombophlebitis were randomized to receive either treatment. Treatments were applied 3 times daily until healing or for a maximum of 7 days. Primary efficacy endpoints were change in length of the venous lesion, proportion of patients with complete healing; while secondary efficacy endpoints included local symptoms, change in the grade of the lesion, global assessment by patients and investigator. Safety of treatment in all patients was evaluated.
Results: Mean change in length of the venous lesion from baseline was significantly higher in heparin QPS group as compared to heparin gel on day 3 (P =0.0144). 90.0% patients in heparin QPS group were healed at day 7 which was significantly higher as compared to 65.7% patients in heparin gel group (P=0.00001). Heparin QPS was also found better in secondary efficacy endpoints. No adverse events were reported in either group.
Conclusions: Heparin QPS was found more effective in treatment of post infusion superficial thrombophlebitis with similar safety profile to heparin gel.
Avinash Supe , B.M. Subnis , M. Rajeev Rao , Vasantray H. Panchal , R. J. Lakhani , Bhavin Mehtalia , Sanjay Kumar H. Maroo*, Ketan R. Patel , Rakesh U. Ojha and Dixit D. Patel
Sr. General Manager, Medical Services Department, Troikaa Pharmaceuticals Ltd., Commerce House 1, Opp.Rajvansh Apartment, Satya Marg, Bodakdev, Ahmedabad - 380054 Gujarat, India
25 June, 2013
29 July, 2013
25 October, 2013
01 November, 2013