Dilutional Coagulopathy in Patients Undergoing Elective Surgery

Summary

The purpose of the present study is to perform a comprehensive description of haemostasis parameters before and after haemodilution with Hydroxyethyl starch (HES) following acute bleeding during elective surgery. Moreover the study aims to test the in vivo haemostatic potential of fibrinogen concentrate in dilutional coagulopathy caused by HES in a clinical, prospective, placebo-controlled randomised setup. We hypothesise; a) A coagulopathy is induced following in vivo haemodilution; b) the coagulopathy is improved or partially improved by fibrinogen.

Timeline

Start

2007-06

Primary completion

2008-04

Completion

2008-04

Publications

• Background Jamnicki M, Zollinger A, Seifert B, Popovic D, Pasch T, Spahn DR. Compromised blood coagulation: an in vitro comparison of hydroxyethyl starch 130/0.4 and hydroxyethyl starch 200/0.5 using thrombelastography. Anesth Analg. 1998 Nov;87(5):989-93. doi: 10.1097/00000539-199811000-00002.
• Background Damon L, Adams M, Stricker RB, Ries C. Intracranial bleeding during treatment with hydroxyethyl starch. N Engl J Med. 1987 Oct 8;317(15):964-5. doi: 10.1056/NEJM198710083171517. No abstract available.
• Background Baldassarre S, Vincent JL. Coagulopathy induced by hydroxyethyl starch. Anesth Analg. 1997 Feb;84(2):451-3. doi: 10.1097/00000539-199702000-00040. No abstract available.
• Background de Jonge E, Levi M, Buller HR, Berends F, Kesecioglu J. Decreased circulating levels of von Willebrand factor after intravenous administration of a rapidly degradable hydroxyethyl starch (HES 200/0.5/6) in healthy human subjects. Intensive Care Med. 2001 Nov;27(11):1825-9. doi: 10.1007/s001340101107. Epub 2001 Sep 26.
• Background Fenger-Eriksen C, Anker-Moller E, Heslop J, Ingerslev J, Sorensen B. Thrombelastographic whole blood clot formation after ex vivo addition of plasma substitutes: improvements of the induced coagulopathy with fibrinogen concentrate. Br J Anaesth. 2005 Mar;94(3):324-9. doi: 10.1093/bja/aei052. Epub 2004 Dec 17.
• Background Fenger-Eriksen C, Ingerslev J, Sorensen B. Coagulopathy induced by colloid plasma expanders--search for an efficacious haemostatic intervention. Acta Anaesthesiol Scand. 2006 Aug;50(7):899-900. doi: 10.1111/j.1399-6576.2006.01054.x. No abstract available.

Drugs

Indications