Dilutional Coagulopathy in Patients Undergoing Elective Surgery
Fibrinogen vs Placebo for Improvement of Clot Strength
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 27, 2007
CompletedFirst Posted
Study publicly available on registry
June 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedDecember 2, 2015
November 1, 2015
10 months
June 27, 2007
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dynamic whole blood clot formation.
60 minutes
Secondary Outcomes (1)
A) Single coagulation factor activities B) Platelet function C) Whole blood clot stability. D) Thrombin generation.
60 minutes
Study Arms (2)
Placebo
PLACEBO COMPARATORNacl
Fibrinogen
ACTIVE COMPARATORFibrinogen
Interventions
Eligibility Criteria
You may qualify if:
- \> 18 years
- Indication for performing cystectomia
- Written informed consent
You may not qualify if:
- Uses of acetyl-salicylic or non-steroid anti-inflammatory drugs 2 days prior to blood sampling.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital, Department of Anaesthesiology
Dk-8200 Aarhus N, Denmark
Related Publications (6)
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.
PMID: 9806670BACKGROUNDDamon 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.
PMID: 2442613BACKGROUNDBaldassarre 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.
PMID: 9024047BACKGROUNDde 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.
PMID: 11810130BACKGROUNDFenger-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.
PMID: 15608046BACKGROUNDFenger-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.
PMID: 16879481BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Else Tønnesen, MD, Prof
Aarhus University Hospital, Department of Anaesthesiology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD MD
Study Record Dates
First Submitted
June 27, 2007
First Posted
June 28, 2007
Study Start
June 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
December 2, 2015
Record last verified: 2015-11