Prevention of Venous Thrombosis in Long-Haul Flights with Flite Tabs: The LONFLIT-FLITE Randomized, Controlled Trial

Abstract

The aim of this study was to evaluate the development of edema, and superficial and deep vein thrombosis (DVT) prophylaxis with an oral profibrinolytic agent (Flite Tabs, 150 mg pinokinase, Aidan, Tempe, AZ, USA) in long-haul flights (7-8 hours), in high-risk subjects. A group of 300 subjects was included; 76 were excluded for several problems including concomitant treatments; 204 were randomized into 2 groups (active treatment or placebo) to evaluate the effects of prophylaxis with Flite Tabs. An exercise program was used in both groups. The femoral, popliteal, tibial, and superficial veins were scanned with ultrasound before and within 90 minutes after flights. Of the included subjects, 92 of 103 controls and 94 of 101 treated subjects completed the study. Dropouts were due to connection problems. Age, gender, and risk distribution were comparable in the groups. In the treatment group, no DVT was observed. In the control group, 5 subjects (5.4%) had a DVT and there were 2 superficial thromboses (7 events in 92 subjects; 7.6%). At inclusion, edema was comparable in the 2 groups. After flights there was an increase in score in controls (+12%) in comparison with a decrease (-15%) in the Flite Tabs group (the difference in variation was statistically significant). Intention-to-treat analysis for thrombotic events shows 18 failures in controls (11 lost to follow-up + 7 thrombotic events) of 92 subjects (19.6%) in comparison with 7 failures (of 94 subjects, equivalent to 7.4%) in the treatment group (p < 0.05). Events were asymptomatic. In conclusion, Flite Tabs were effective in reducing thrombotic events and in controlling edema in high-risk subjects in long flights.

Prevention of VTE in Nonsurgical Patients

“…All but one of these trials was conducted by a single group of investigators. 140,[143][144][145][146][147][148][149][150] Trials enrolled a mix of low-and increased-risk subjects based on risk factors for VTE, and most studies included persons taking fl ights of . 7 h. Asymptomatic DVT detected by screening ultrasound examination was the primary end point.…”

Consequence of Patient Substitution of Nattokinase for Warfarin After Aortic Valve Replacement with a Mechanical Prosthesis

“…Subsequently, there has been some preliminary evidence of thrombolysis in rats Consequence of patient substitution of nattokinase for warfarin after aortic valve replacement with a mechanical prosthesis Maqsood M. Elahi, PhD, Charles H. Choi, BS, Subbareddy Konda, MD, and Jay G. Shake, MD (3,4) and evidence of complete dissolution of arterial thrombi within 5 hours of oral administration of nattokinase in dogs (5). However, the authors of this case report have found limited data on the anticoagulation properties of natto and nattokinase in human subjects (6)(7)(8). Th rombin activity has been found to be increased following thrombolysis, which in turn may have paradoxically increased our patient's risk of valve thrombosis (9,10).…”

Pycnogenol® bei Erkrankungen des venösen Systems - eine systematische Übersicht

“…In der PlaceboGruppe wurden 5% Thrombosen am Zielort mittels Ultraschall gefunden. Die Passagiere hatten 2-3 h vor dem Start 200 mg, 6 h später 200 mg und am folgenden Tag 100 mg Pycnogenol genommen [24]. Darüber hinaus besserte Pycnogenol die Jetlag-Symptome im Vergleich zu Placebo [25].…”