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Fibrinogen substitution improves whole blood clot firmness after dilution with hydroxyethyl starch in bleeding patients undergoing radical cystectomy: a randomized, placebo-controlled clinical trial.
J Thromb Haemost. 2009 May; 7(5):795-802.JT

Abstract

SUMMARY BACKGROUND

Infusion of artificial colloids such as hydroxyethyl starch (HES) induces coagulopathy to a greater extent than simple dilution. Several studies have suggested that the coagulopathy could be corrected by substitution with a fibrinogen concentrate.

OBJECTIVES

The aims of the present prospective, randomized, placebo-controlled trial were to investigate the hemostatic effect of a fibrinogen concentrate after coagulopathy induced by hydroxyethyl starch in patients experiencing sudden excessive bleeding during elective cystectomy.

METHODS

Twenty patients were included. Blood loss was substituted 1:1 with HES 130/0.4. At a dilution level of 30%, patients were randomly selected for intra-operative administration of a fibrinogen concentrate or placebo. The primary endpoint was maximum clot firmness (MCF), as assessed by thromboelastometry. Secondary endpoints were blood loss and transfusion requirements, other thromboelastometry parameters, thrombin generation and platelet function.

RESULTS

Whole-blood MCF was significantly reduced after 30% dilution in vivo with HES. The placebo resulted in a further decline of the MCF, whereas randomized administration of fibrinogen significantly increased the MCF. Furthermore, only 2 out of 10 patients randomly chosen to receive fibrinogen substitution required postoperative red blood cell transfusions, compared with 8 out of 10 in the placebo group (P = 0.023). Platelet function and thrombin generation were reduced after 30% hemodilution in vivo, and fibrinogen administration caused no significant changes.

CONCLUSIONS

During cystectomy, fluid resuscitation with HES 130/0.4 during sudden excessive bleeding induces coagulopathy that shows reduced whole-blood maximum clot firmness. Randomized administration of fibrinogen concentrate significantly improved maximum clot firmness and reduced the requirement for postoperative transfusion.

Authors+Show Affiliations

Department of Anaesthesiology, Center for Haemophilia and Thrombosis, Aarhus, Denmark.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

19320829

Citation

Fenger-Eriksen, C, et al. "Fibrinogen Substitution Improves Whole Blood Clot Firmness After Dilution With Hydroxyethyl Starch in Bleeding Patients Undergoing Radical Cystectomy: a Randomized, Placebo-controlled Clinical Trial." Journal of Thrombosis and Haemostasis : JTH, vol. 7, no. 5, 2009, pp. 795-802.
Fenger-Eriksen C, Jensen TM, Kristensen BS, et al. Fibrinogen substitution improves whole blood clot firmness after dilution with hydroxyethyl starch in bleeding patients undergoing radical cystectomy: a randomized, placebo-controlled clinical trial. J Thromb Haemost. 2009;7(5):795-802.
Fenger-Eriksen, C., Jensen, T. M., Kristensen, B. S., Jensen, K. M., Tønnesen, E., Ingerslev, J., & Sørensen, B. (2009). Fibrinogen substitution improves whole blood clot firmness after dilution with hydroxyethyl starch in bleeding patients undergoing radical cystectomy: a randomized, placebo-controlled clinical trial. Journal of Thrombosis and Haemostasis : JTH, 7(5), 795-802. https://doi.org/10.1111/j.1538-7836.2009.03331.x
Fenger-Eriksen C, et al. Fibrinogen Substitution Improves Whole Blood Clot Firmness After Dilution With Hydroxyethyl Starch in Bleeding Patients Undergoing Radical Cystectomy: a Randomized, Placebo-controlled Clinical Trial. J Thromb Haemost. 2009;7(5):795-802. PubMed PMID: 19320829.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fibrinogen substitution improves whole blood clot firmness after dilution with hydroxyethyl starch in bleeding patients undergoing radical cystectomy: a randomized, placebo-controlled clinical trial. AU - Fenger-Eriksen,C, AU - Jensen,T M, AU - Kristensen,B S, AU - Jensen,K M, AU - Tønnesen,E, AU - Ingerslev,J, AU - Sørensen,B, Y1 - 2009/03/05/ PY - 2009/3/27/entrez PY - 2009/3/27/pubmed PY - 2009/8/6/medline SP - 795 EP - 802 JF - Journal of thrombosis and haemostasis : JTH JO - J Thromb Haemost VL - 7 IS - 5 N2 - SUMMARY BACKGROUND: Infusion of artificial colloids such as hydroxyethyl starch (HES) induces coagulopathy to a greater extent than simple dilution. Several studies have suggested that the coagulopathy could be corrected by substitution with a fibrinogen concentrate. OBJECTIVES: The aims of the present prospective, randomized, placebo-controlled trial were to investigate the hemostatic effect of a fibrinogen concentrate after coagulopathy induced by hydroxyethyl starch in patients experiencing sudden excessive bleeding during elective cystectomy. METHODS: Twenty patients were included. Blood loss was substituted 1:1 with HES 130/0.4. At a dilution level of 30%, patients were randomly selected for intra-operative administration of a fibrinogen concentrate or placebo. The primary endpoint was maximum clot firmness (MCF), as assessed by thromboelastometry. Secondary endpoints were blood loss and transfusion requirements, other thromboelastometry parameters, thrombin generation and platelet function. RESULTS: Whole-blood MCF was significantly reduced after 30% dilution in vivo with HES. The placebo resulted in a further decline of the MCF, whereas randomized administration of fibrinogen significantly increased the MCF. Furthermore, only 2 out of 10 patients randomly chosen to receive fibrinogen substitution required postoperative red blood cell transfusions, compared with 8 out of 10 in the placebo group (P = 0.023). Platelet function and thrombin generation were reduced after 30% hemodilution in vivo, and fibrinogen administration caused no significant changes. CONCLUSIONS: During cystectomy, fluid resuscitation with HES 130/0.4 during sudden excessive bleeding induces coagulopathy that shows reduced whole-blood maximum clot firmness. Randomized administration of fibrinogen concentrate significantly improved maximum clot firmness and reduced the requirement for postoperative transfusion. SN - 1538-7836 UR - https://www.unboundmedicine.com/medline/citation/19320829/Fibrinogen_substitution_improves_whole_blood_clot_firmness_after_dilution_with_hydroxyethyl_starch_in_bleeding_patients_undergoing_radical_cystectomy:_a_randomized_placebo_controlled_clinical_trial_ L2 - https://doi.org/10.1111/j.1538-7836.2009.03331.x DB - PRIME DP - Unbound Medicine ER -