Dilutional Coagulopathy in Patients Undergoing Elective Surgery
NCT ID: NCT00493272
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2007-06-30
2008-04-30
Brief Summary
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We hypothesise; a) A coagulopathy is induced following in vivo haemodilution; b) the coagulopathy is improved or partially improved by fibrinogen.
Detailed Description
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Experimental laboratory studies performed in our centre and verified by several other research groups have shown successful reversal of the colloid plasma expander induced coagulopathy by fibrinogen concentrate.10-13 So far, the present knowledge are based on laboratory experiments and animal studies. Hence, it appears desirable to perform a comprehensive description of haemostasis parameters following HES induced dilutional coagulopathy in an acute clinical bleeding situation.
Materials and Methods
Study design: Clinical, prospective, double-blind, randomised, place-controlled trial. Blood samples:
Primary end point:
Dynamic whole blood clot formation
Secondary end points:
A) Single coagulation factor activities B) Platelet function C) Whole blood clot stability. D) Thrombin generation
Perspectives:
Serious surgical and traumatic bleedings are common and associated with a high mortality rate. The present study can significantly contribute to our overall understanding of the mechanisms involved in HES induced dilutional coagulopathy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Placebo
Nacl
Fibrinogen
Fibrinogen behandling
Fibrinogen
Fibrinogen
Fibrinogen
Fibrinogen behandling
Interventions
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Fibrinogen
Fibrinogen behandling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Indication for performing cystectomia
* Written informed consent
Exclusion Criteria
* Abnormal preoperative coagulations parameters (Platelets, PP, APTT, D- dimer, Fibrinogen, AT, TT)
* Disseminated cancer and/or bone metastasis
* Medical history of ischemic heart disease, claudicatio, or arteriosclerosis
* Medical history of previous thrombo-embolic event
* Renal failure defined as clinical relevant abnormal levels of creatinine
* Liver failure defined as clinical relevant abnormal levels of ALAT
* Hypersensibility to Voluven, Haemocomplettan or ingredients
* Fertile women not using safe contraception
18 Years
ALL
No
Sponsors
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Christian Fenger-Eriksen
OTHER
Responsible Party
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Christian Fenger-Eriksen
PhD MD
Principal Investigators
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Else Tønnesen, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital, Department of Anaesthesiology
Locations
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Aarhus University Hospital, Department of Anaesthesiology
Dk-8200 Aarhus N, , Denmark
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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20070037
Identifier Type: -
Identifier Source: org_study_id