Evaluation of Safety and Efficacy of Quick Penetrating Heparin Solution (1000 IU/ml) in Prevention

What is it about?

Evaluation of Safety and Efficacy of Quick Penetrating Heparin Solution (1000 IU/ml) in Prevention

Featured Image

Photo by Azwedo L.LC on Unsplash

Photo by Azwedo L.LC on Unsplash

Why is it important?

Background and Aims: To evaluate the safety and efficacy of marketed heparin sodium topical solution (1000 IU/ml) compared to no heparin topical treatment group for prevention of infusion associated thrombophlebitis. Methods: A prospective, randomized, parallel group, comparative, single centre, clinical study. A total 100 patients undergoing intravenous cannulation that has been planned to remain in situ for at least 48 hours indoor period were enrolled. Patients were randomized in Group A (Heparin Topical solution) vs Group B (No Heparin Topical solution). Investigational product was applied on skin around dressing covering intravenous cannulation site approximately every 8 hours for the treatment period of 48 hours. Patients were evaluated for incidences of infusion phlebitis, first signs of phlebitis and treatment emergent application site reactions and were statistically analyzed for statistical significance, p - value below 0.05 levels was considered to be significant. Results: Incidences of infusion phlebitis Grade 2 was found to be higher in “no treatment group” than in “Topical Heparin Group” (20 vs 6 patients; p = 0.00205). Incidences of first sign of phlebitis grade was found to be higher in “no treatment group” than in “Topical Heparin Group” (48 vs 25 patients; p = 0.000). Time to develop first sign of phlebitis was lesser in “No Treatment Group” than in Topical Heparin Group (26 hr vs 36 hr; p = 0.0023). Also, none of the patient in the Heparin Group develop the thrombophlebitis (Grade IV- advance stage of phlebitis). Conclusions: Topical solution of Heparin Sodium 1000 IU/ml was found to be effective and safe in preventing infusion related phlebitis.

Perspectives