Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery

Congenital Heart Disease Clinical Trial

Official title:

Influence of Preoperative Fibrinogen Levels on Blood Loss and Transfusions in Pediatric Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05525195
• Other study ID #: card_ped_fibri
• Status: Completed
• Start date: September 17, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: July 2023
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fibrinogen plays an important role in the coagulation cascade. Low levels of preoperative fibrinogen have been associated in adults with higher blood and transfusion requirements during surgery. Guidelines from the European Society of Anesthesiology and Intensive Care recommends fibrinogen substitution based on viscoelastic tests in adult cardiac surgery. Cardiopulmonary bypass results in a profound hemodilution and dilution of all coagulation factors. This is especially true in children where the priming volume of the cardiopulmonary bypass circuit is much higher compared to the patient's weight than in adults. Cardiopulmonary bypass generates high levels of tissue plasminogen activator resulting in a hyperfibrinolysis, further lowering fibrinogen levels. The aim of this retrospective study is to explore a possible relationship between preoperative fibrinogen levels and perioperative blood loss, as well as transfusion requirements in children undergoing cardiac surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 932
• Est. completion date: February 10, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• all children with cardiac surgery under cardiopulmonary bypass between 2008 and 2018
• Age < 16 year

Exclusion Criteria:

• preoperative coagulopathy
• Jehovah's witnesses
• patients with fresh frozen plasma in the priming of the cardiopulmonary bypass circuit

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• Congenital cardiac surgery
All children who underwent congenital cardiac surgery with cardiopulmonary bypass between 2008 and 2018

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire des Enfants Reine Fabiola	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (20)

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Charbonneau H, Pasquie M, Mayeur N. Preoperative plasma fibrinogen level and transfusion in cardiac surgery: a biphasic correlation. Interact Cardiovasc Thorac Surg. 2020 Nov 1;31(5):622-625. doi: 10.1093/icvts/ivaa153. — View Citation

Corum LE, Hlady V. The effect of upstream platelet-fibrinogen interactions on downstream adhesion and activation. Biomaterials. 2012 Feb;33(5):1255-60. doi: 10.1016/j.biomaterials.2011.10.074. Epub 2011 Nov 17. — View Citation

Faraoni D, Willems A, Savan V, Demanet H, De Ville A, Van der Linden P. Plasma fibrinogen concentration is correlated with postoperative blood loss in children undergoing cardiac surgery. A retrospective review. Eur J Anaesthesiol. 2014 Jun;31(6):317-26. doi: 10.1097/EJA.0000000000000043. — View Citation

Gielen C, Dekkers O, Stijnen T, Schoones J, Brand A, Klautz R, Eikenboom J. The effects of pre- and postoperative fibrinogen levels on blood loss after cardiac surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2014 Mar;18(3):292-8. doi: 10.1093/icvts/ivt506. Epub 2013 Dec 6. — View Citation

Grottke O, Mallaiah S, Karkouti K, Saner F, Haas T. Fibrinogen Supplementation and Its Indications. Semin Thromb Hemost. 2020 Feb;46(1):38-49. doi: 10.1055/s-0039-1696946. Epub 2019 Oct 1. — View Citation

Guzzetta NA, Miller BE. Principles of hemostasis in children: models and maturation. Paediatr Anaesth. 2011 Jan;21(1):3-9. doi: 10.1111/j.1460-9592.2010.03410.x. Epub 2010 Sep 16. — View Citation

Kozek-Langenecker SA, Ahmed AB, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Haas T, Jacob M, Lance MD, Pitarch JVL, Mallett S, Meier J, Molnar ZL, Rahe-Meyer N, Samama CM, Stensballe J, Van der Linden PJF, Wikkelso AJ, Wouters P, Wyffels P, Zacharowski K. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016. Eur J Anaesthesiol. 2017 Jun;34(6):332-395. doi: 10.1097/EJA.0000000000000630. — View Citation

Lacroix J, Hebert PC, Hutchison JS, Hume HA, Tucci M, Ducruet T, Gauvin F, Collet JP, Toledano BJ, Robillard P, Joffe A, Biarent D, Meert K, Peters MJ; TRIPICU Investigators; Canadian Critical Care Trials Group; Pediatric Acute Lung Injury and Sepsis Investigators Network. Transfusion strategies for patients in pediatric intensive care units. N Engl J Med. 2007 Apr 19;356(16):1609-19. doi: 10.1056/NEJMoa066240. — View Citation

Paparella D, Brister SJ, Buchanan MR. Coagulation disorders of cardiopulmonary bypass: a review. Intensive Care Med. 2004 Oct;30(10):1873-81. doi: 10.1007/s00134-004-2388-0. Epub 2004 Jul 24. — View Citation

Ranucci M, Bianchi P, Cotza M, Beccaris C, Silvetti S, Isgro G, Giamberti A, Baryshnikova E. Fibrinogen levels and postoperative chest drain blood loss in low-weight (<10 kg) children undergoing cardiac surgery. Perfusion. 2019 Nov;34(8):629-636. doi: 10.1177/0267659119854246. Epub 2019 Jun 28. — View Citation

Ranucci M, Jeppsson A, Baryshnikova E. Pre-operative fibrinogen supplementation in cardiac surgery patients: an evaluation of different trigger values. Acta Anaesthesiol Scand. 2015 Apr;59(4):427-33. doi: 10.1111/aas.12469. Epub 2015 Jan 20. — View Citation

Ravn HB. Hemostasis in Pediatric Cardiac Surgery. Semin Thromb Hemost. 2017 Oct;43(7):682-690. doi: 10.1055/s-0037-1603365. Epub 2017 Jun 8. No abstract available. — View Citation

Scrucca L, Fop M, Murphy TB, Raftery AE. mclust 5: Clustering, Classification and Density Estimation Using Gaussian Finite Mixture Models. R J. 2016 Aug;8(1):289-317. — View Citation

Spiezia L, Di Gregorio G, Campello E, Maggiolo S, Bortolussi G, Stellin G, Simioni P, Vida V. Predictors of postoperative bleeding in children undergoing cardiopulmonary bypass: A preliminary Italian study. Thromb Res. 2017 May;153:85-89. doi: 10.1016/j.thromres.2017.03.021. Epub 2017 Mar 22. — View Citation

Van der Linden P, Dumoulin M, Van Lerberghe C, Torres CS, Willems A, Faraoni D. Efficacy and safety of 6% hydroxyethyl starch 130/0.4 (Voluven) for perioperative volume replacement in children undergoing cardiac surgery: a propensity-matched analysis. Crit Care. 2015 Mar 17;19(1):87. doi: 10.1186/s13054-015-0830-z. — View Citation

Walden K, Jeppsson A, Nasic S, Backlund E, Karlsson M. Low preoperative fibrinogen plasma concentration is associated with excessive bleeding after cardiac operations. Ann Thorac Surg. 2014 Apr;97(4):1199-206. doi: 10.1016/j.athoracsur.2013.11.064. Epub 2014 Feb 6. — View Citation

Weisel JW, Litvinov RI. Fibrin Formation, Structure and Properties. Subcell Biochem. 2017;82:405-456. doi: 10.1007/978-3-319-49674-0_13. — View Citation

Willems A, Harrington K, Lacroix J, Biarent D, Joffe AR, Wensley D, Ducruet T, Hebert PC, Tucci M; TRIPICU investigators; Canadian Critical Care Trials Group; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Comparison of two red-cell transfusion strategies after pediatric cardiac surgery: a subgroup analysis. Crit Care Med. 2010 Feb;38(2):649-56. doi: 10.1097/CCM.0b013e3181bc816c. — View Citation

Willems A, Patte P, De Groote F, Van der Linden P. Cyanotic heart disease is an independent predicting factor for fresh frozen plasma and platelet transfusion after cardiac surgery. Transfus Apher Sci. 2019 Jun;58(3):304-309. doi: 10.1016/j.transci.2019.03.014. Epub 2019 Mar 19. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	Blood loss in mL during surgery and postoperatively during the first 24h (day 0) will be extracted from our database	Day 0
Primary	Transfusion requirements	Transfusion requirements of packed red cells ( in mL), fresh frozen plasma (in mL) and platelets (in mL) during the first 24h (day 0) will be extracted from our database	Day 0