AzTrials
AzTrials

Cardiac SurgeryNCT05525195

Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery

An observational study of Cardiac Surgery and Congenital Heart Disease, run by Brugmann University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages Up to 16 years
What is being tested?
Congenital cardiac surgery
Type of treatment
Surgery or procedure
How many people
932 participants
Where
1 siteBelgium
Study dates
17 Sep 2022to 10 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: All children under 16 year, with cardiac surgery under cardiopulmonary bypass between 2008 and 2018 at our institution

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Hôpital Universitaire des Enfants Reine Fabiola

    Brussels, 1020

Other trials in Belgium

About this study

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

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.

Being tested
Congenital cardiac surgery
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Congenital cardiac surgeryProcedure or surgery

    All children who underwent congenital cardiac surgery with cardiopulmonary bypass between 2008 and 2018

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood loss

    Blood loss in mL during surgery and postoperatively during the first 24h (day 0) will be extracted from our database

    Measured: Day 0

  2. 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

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study start17 Sep 2022
  3. Primary completion25 Jan 2023
  4. Study completion10 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
932 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05525195
Sponsor's protocol ID
card_ped_fibri
Status last verified
Jul 2023
First submitted
29 Aug 2022
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 28101869

  • 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.

    PubMed 31574543

  • 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.

    PubMed 22100981

  • 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.

    PubMed 20849450

  • 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.

    PubMed 33137819

  • 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.

    PubMed 28459785

  • 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.

    PubMed 24503704

  • 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.

    PubMed 15278267

  • 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.

    PubMed 28597463

  • 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.

    PubMed 24507940

  • 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.

    PubMed 24316606

  • 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.

    PubMed 25600583

  • 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.

    PubMed 31250738

  • 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.

    PubMed 28359027

  • 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.

    PubMed 30904398

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Surgery and Congenital Heart Disease, run by Brugmann University Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood loss (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05525195, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in