The aim of this study was to evaluate the occurrence of deep venous thrombosis (DVT) and superficial vein thrombosis (SVT) and its prophylaxis with an oral anti-edema and antithrombotic agent (Pycnogenol, Horphag, Research Management SA, Geneva, Switzerland) in long-haul flights, in subjects at moderate to high-risk of DVT and SVT. The study pre-included 244 pre-selected subjects; 211 were included (33 were excluded for several reasons due to logistic problems) and 198 completed the study; 13 subjects were lost for follow-up at the end of the flight, all for non-medical problems (i.e., for difficult connections). All subjects were scanned within 90 minutes before the flight and within 2 hours after disembarking. Subjects were supplemented with 100 mg Pycnogenol per capsule. Treatment subjects received two capsules between 2 and 3 hours before flights with 250 mL of water; two capsules were taken 6 hours later with 250 mL of water and one capsule the next day. The control group received comparable placebo at the same intervals. The flight duration was on average 8 hours and 15 minutes (SD 55 min) (range, 7.45-12.33). In the control group there were five thrombotic events (one DVT and four superficial thromboses) while only nonthrombotic, localized phlebitis was observed in the Pycnogenol group (5.15% vs. no events; p<0.025). The ITT (intention to treat) analysis detects 13 failures in the control group (eight lost to follow up + five thrombotic events) of 105 subjects (12.4%) vs. five failures (4.7%; all lost, no thrombotic events) in the treatment group (p<0.025). No unwanted effects were observed. In conclusion, this study indicates that Pycnogenol treatment was effective in decreasing the number of thrombotic events (DVT and SVT) in moderate-to-high risk subjects, during long-haul flights.

Prevention of venous thrombosis and thrombophlebitis in long-haul flights with pycnogenol / G. Belcaro, M. R. Cesarone, P. Rohdewald, A. Ricci, E. Ippolito, M. Dugall, M. Griffin, I. Ruffini, G. Acerbi, M. G. Vinciguerra, P. Bavera, A. Di Renzo, B. M. Errichi, F. Cerritelli. - In: CLINICAL AND APPLIED THROMBOSIS-HEMOSTASIS. - ISSN 1076-0296. - 10:4(2004 Oct), pp. 373-377.

Prevention of venous thrombosis and thrombophlebitis in long-haul flights with pycnogenol

E. Ippolito;
2004

Abstract

The aim of this study was to evaluate the occurrence of deep venous thrombosis (DVT) and superficial vein thrombosis (SVT) and its prophylaxis with an oral anti-edema and antithrombotic agent (Pycnogenol, Horphag, Research Management SA, Geneva, Switzerland) in long-haul flights, in subjects at moderate to high-risk of DVT and SVT. The study pre-included 244 pre-selected subjects; 211 were included (33 were excluded for several reasons due to logistic problems) and 198 completed the study; 13 subjects were lost for follow-up at the end of the flight, all for non-medical problems (i.e., for difficult connections). All subjects were scanned within 90 minutes before the flight and within 2 hours after disembarking. Subjects were supplemented with 100 mg Pycnogenol per capsule. Treatment subjects received two capsules between 2 and 3 hours before flights with 250 mL of water; two capsules were taken 6 hours later with 250 mL of water and one capsule the next day. The control group received comparable placebo at the same intervals. The flight duration was on average 8 hours and 15 minutes (SD 55 min) (range, 7.45-12.33). In the control group there were five thrombotic events (one DVT and four superficial thromboses) while only nonthrombotic, localized phlebitis was observed in the Pycnogenol group (5.15% vs. no events; p<0.025). The ITT (intention to treat) analysis detects 13 failures in the control group (eight lost to follow up + five thrombotic events) of 105 subjects (12.4%) vs. five failures (4.7%; all lost, no thrombotic events) in the treatment group (p<0.025). No unwanted effects were observed. In conclusion, this study indicates that Pycnogenol treatment was effective in decreasing the number of thrombotic events (DVT and SVT) in moderate-to-high risk subjects, during long-haul flights.
English
Airplanes; Edema; Fibrinolysis; Flight-microangiopathy; Long-haul flights; Noninvasive investigations; Prevention; Travel; Ultrasound; Venous thrombosis
Settore MED/22 - Chirurgia Vascolare
Articolo
Esperti anonimi
ott-2004
10
4
373
377
Pubblicato
Periodico con rilevanza internazionale
Pubmed
info:eu-repo/semantics/article
Prevention of venous thrombosis and thrombophlebitis in long-haul flights with pycnogenol / G. Belcaro, M. R. Cesarone, P. Rohdewald, A. Ricci, E. Ippolito, M. Dugall, M. Griffin, I. Ruffini, G. Acerbi, M. G. Vinciguerra, P. Bavera, A. Di Renzo, B. M. Errichi, F. Cerritelli. - In: CLINICAL AND APPLIED THROMBOSIS-HEMOSTASIS. - ISSN 1076-0296. - 10:4(2004 Oct), pp. 373-377.
none
Prodotti della ricerca::01 - Articolo su periodico
14
262
Article (author)
si
G. Belcaro, M. R. Cesarone, P. Rohdewald, A. Ricci, E. Ippolito, M. Dugall, M. Griffin, I. Ruffini, G. Acerbi, M. G. Vinciguerra, P. Bavera, A. Di Ren...espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/210148
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