Safety of antifibrinolytics in cranial vault reconstructive surgery: a report from the pediatric craniofacial collaborative group

Susan M. Goobie, Franklyn P. Cladis, Chris D. Glover, Henry Huang, Srijaya K. Reddy, Allison M. Fernandez, David Zurakowski, Paul A. Stricker, John Fiadjoe, Codruta Soneru, Ricardo Falcon, Timothy Petersen, Courtney Kowalczyk-Derderian, Nicholas Dalesio, Stefan Budac, Neels Groenewald, Daniel Rubens, Douglas Thompson, Rheana Watts, Katherine GentryIskra Ivanova, Mali Hetmaniuk, Vincent Hsieh, Michael Collins, Karen Wong, Wendy Binstock, Russell Reid, Kim Poteet-Schwartz, Heike Gries, Rebecca Hall, Jeffrey Koh, Kelsey Colpitts, Lauren Scott, Carolyn Bannister, Wai Sung, Ranu Jain, Rabail Chaudhry, Gerald F. Tuite, Ernesto Ruas, Oleg Drozhinin, Lisa Tetreault, Bridget Muldowney, Karene Ricketts, Patrick Fernandez, Lisa Sohn, John Hajduk, Brad Taicher, Jessica Burkhart, Allison Wright, Veronica Busso, the Pediatric Craniofacial Collaborative Group

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Background: Antifibrinolytic therapy significantly decreases blood loss and transfusion in pediatric cranial vault reconstructive surgery; however, concern regarding the side effects profile limits clinical use. Aims: The aim was to utilize the Pediatric Craniofacial Surgery Perioperative Registry database to identify the safety profile of antifibrinolytic therapy for cranial vault reconstructive surgery by reporting the incidence of adverse events as they relate to exposure to tranexamic acid and aminocaproic acid compared to no exposure to antifibrinolytics. Methods: The database was queried for cases of open cranial vault reconstructive surgery. Less invasive procedures such as neuro-endoscopic and spring-mediated cranioplasties were excluded. The outcomes evaluated included any perioperative neurological adverse event including seizures or seizure-like movements and thromboembolic events. Results: Thirty-one institutions reported a total of 1638 cases from 2010 to 2015. Total antifibrinolytic administration accounted for 59.5% (tranexamic acid, 36.1% and aminocaproic acid, 23.4%), with 40.5% not receiving any antifibrinolytic. The overall incidence of postoperative seizures or seizure-like movements was 0.6%. No significant difference was detected in the incidence of postoperative seizures between patients receiving tranexamic acid and those receiving aminocaproic acid [the odds ratio for seizures being 0.34 (95% confidence interval: 0.07–1.85) controlling for American Society of Anesthesia (ASA) physical class] nor in patients receiving antifibrinolytics compared to those not administered antifibrinolytics (the odds ratio for seizures being 1.02 (confidence interval 0.29–3.63) controlling for ASA physical class). One complicated patient in the antifibrinolytic group with a femoral venous catheter had a postoperative deep venous thrombosis. Conclusions: This is the first report of an incidence of postoperative seizures of 0.6% in pediatric cranial vault reconstructive surgery. There was no significant difference in postoperative seizures or seizure-like events in those patients who received the tranexamic acid or aminocaproic acid vs those that did not. This report provides evidence of the safety profile of antifibrinolytic in children having noncardiac major surgery. Caution should prevail however in using antifibrinolytic in high-risk patients. Antifibrinolytic dosage regimes should be based on pharmacokinetic data avoiding high doses.

Original languageEnglish (US)
Pages (from-to)271-281
Number of pages11
JournalPaediatric Anaesthesia
Volume27
Issue number3
DOIs
StatePublished - Mar 1 2017
Externally publishedYes

Fingerprint

Reconstructive Surgical Procedures
Antifibrinolytic Agents
Seizures
Pediatrics
Safety
Tranexamic Acid
Aminocaproic Acid
Incidence
Anesthesia
Odds Ratio
Databases
Confidence Intervals
Thigh
Venous Thrombosis
Blood Transfusion

Keywords

  • aminocaproic acid
  • antifibrinolytics
  • craniofacial surgery
  • craniosynostosis
  • safety
  • tranexamic acid

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Anesthesiology and Pain Medicine

Cite this

Goobie, S. M., Cladis, F. P., Glover, C. D., Huang, H., Reddy, S. K., Fernandez, A. M., ... the Pediatric Craniofacial Collaborative Group (2017). Safety of antifibrinolytics in cranial vault reconstructive surgery: a report from the pediatric craniofacial collaborative group. Paediatric Anaesthesia, 27(3), 271-281. https://doi.org/10.1111/pan.13076

Safety of antifibrinolytics in cranial vault reconstructive surgery : a report from the pediatric craniofacial collaborative group. / Goobie, Susan M.; Cladis, Franklyn P.; Glover, Chris D.; Huang, Henry; Reddy, Srijaya K.; Fernandez, Allison M.; Zurakowski, David; Stricker, Paul A.; Fiadjoe, John; Soneru, Codruta; Falcon, Ricardo; Petersen, Timothy; Kowalczyk-Derderian, Courtney; Dalesio, Nicholas; Budac, Stefan; Groenewald, Neels; Rubens, Daniel; Thompson, Douglas; Watts, Rheana; Gentry, Katherine; Ivanova, Iskra; Hetmaniuk, Mali; Hsieh, Vincent; Collins, Michael; Wong, Karen; Binstock, Wendy; Reid, Russell; Poteet-Schwartz, Kim; Gries, Heike; Hall, Rebecca; Koh, Jeffrey; Colpitts, Kelsey; Scott, Lauren; Bannister, Carolyn; Sung, Wai; Jain, Ranu; Chaudhry, Rabail; Tuite, Gerald F.; Ruas, Ernesto; Drozhinin, Oleg; Tetreault, Lisa; Muldowney, Bridget; Ricketts, Karene; Fernandez, Patrick; Sohn, Lisa; Hajduk, John; Taicher, Brad; Burkhart, Jessica; Wright, Allison; Busso, Veronica; the Pediatric Craniofacial Collaborative Group.

In: Paediatric Anaesthesia, Vol. 27, No. 3, 01.03.2017, p. 271-281.

Research output: Contribution to journalArticle

Goobie, SM, Cladis, FP, Glover, CD, Huang, H, Reddy, SK, Fernandez, AM, Zurakowski, D, Stricker, PA, Fiadjoe, J, Soneru, C, Falcon, R, Petersen, T, Kowalczyk-Derderian, C, Dalesio, N, Budac, S, Groenewald, N, Rubens, D, Thompson, D, Watts, R, Gentry, K, Ivanova, I, Hetmaniuk, M, Hsieh, V, Collins, M, Wong, K, Binstock, W, Reid, R, Poteet-Schwartz, K, Gries, H, Hall, R, Koh, J, Colpitts, K, Scott, L, Bannister, C, Sung, W, Jain, R, Chaudhry, R, Tuite, GF, Ruas, E, Drozhinin, O, Tetreault, L, Muldowney, B, Ricketts, K, Fernandez, P, Sohn, L, Hajduk, J, Taicher, B, Burkhart, J, Wright, A, Busso, V & the Pediatric Craniofacial Collaborative Group 2017, 'Safety of antifibrinolytics in cranial vault reconstructive surgery: a report from the pediatric craniofacial collaborative group', Paediatric Anaesthesia, vol. 27, no. 3, pp. 271-281. https://doi.org/10.1111/pan.13076
Goobie, Susan M. ; Cladis, Franklyn P. ; Glover, Chris D. ; Huang, Henry ; Reddy, Srijaya K. ; Fernandez, Allison M. ; Zurakowski, David ; Stricker, Paul A. ; Fiadjoe, John ; Soneru, Codruta ; Falcon, Ricardo ; Petersen, Timothy ; Kowalczyk-Derderian, Courtney ; Dalesio, Nicholas ; Budac, Stefan ; Groenewald, Neels ; Rubens, Daniel ; Thompson, Douglas ; Watts, Rheana ; Gentry, Katherine ; Ivanova, Iskra ; Hetmaniuk, Mali ; Hsieh, Vincent ; Collins, Michael ; Wong, Karen ; Binstock, Wendy ; Reid, Russell ; Poteet-Schwartz, Kim ; Gries, Heike ; Hall, Rebecca ; Koh, Jeffrey ; Colpitts, Kelsey ; Scott, Lauren ; Bannister, Carolyn ; Sung, Wai ; Jain, Ranu ; Chaudhry, Rabail ; Tuite, Gerald F. ; Ruas, Ernesto ; Drozhinin, Oleg ; Tetreault, Lisa ; Muldowney, Bridget ; Ricketts, Karene ; Fernandez, Patrick ; Sohn, Lisa ; Hajduk, John ; Taicher, Brad ; Burkhart, Jessica ; Wright, Allison ; Busso, Veronica ; the Pediatric Craniofacial Collaborative Group. / Safety of antifibrinolytics in cranial vault reconstructive surgery : a report from the pediatric craniofacial collaborative group. In: Paediatric Anaesthesia. 2017 ; Vol. 27, No. 3. pp. 271-281.
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title = "Safety of antifibrinolytics in cranial vault reconstructive surgery: a report from the pediatric craniofacial collaborative group",
abstract = "Background: Antifibrinolytic therapy significantly decreases blood loss and transfusion in pediatric cranial vault reconstructive surgery; however, concern regarding the side effects profile limits clinical use. Aims: The aim was to utilize the Pediatric Craniofacial Surgery Perioperative Registry database to identify the safety profile of antifibrinolytic therapy for cranial vault reconstructive surgery by reporting the incidence of adverse events as they relate to exposure to tranexamic acid and aminocaproic acid compared to no exposure to antifibrinolytics. Methods: The database was queried for cases of open cranial vault reconstructive surgery. Less invasive procedures such as neuro-endoscopic and spring-mediated cranioplasties were excluded. The outcomes evaluated included any perioperative neurological adverse event including seizures or seizure-like movements and thromboembolic events. Results: Thirty-one institutions reported a total of 1638 cases from 2010 to 2015. Total antifibrinolytic administration accounted for 59.5{\%} (tranexamic acid, 36.1{\%} and aminocaproic acid, 23.4{\%}), with 40.5{\%} not receiving any antifibrinolytic. The overall incidence of postoperative seizures or seizure-like movements was 0.6{\%}. No significant difference was detected in the incidence of postoperative seizures between patients receiving tranexamic acid and those receiving aminocaproic acid [the odds ratio for seizures being 0.34 (95{\%} confidence interval: 0.07–1.85) controlling for American Society of Anesthesia (ASA) physical class] nor in patients receiving antifibrinolytics compared to those not administered antifibrinolytics (the odds ratio for seizures being 1.02 (confidence interval 0.29–3.63) controlling for ASA physical class). One complicated patient in the antifibrinolytic group with a femoral venous catheter had a postoperative deep venous thrombosis. Conclusions: This is the first report of an incidence of postoperative seizures of 0.6{\%} in pediatric cranial vault reconstructive surgery. There was no significant difference in postoperative seizures or seizure-like events in those patients who received the tranexamic acid or aminocaproic acid vs those that did not. This report provides evidence of the safety profile of antifibrinolytic in children having noncardiac major surgery. Caution should prevail however in using antifibrinolytic in high-risk patients. Antifibrinolytic dosage regimes should be based on pharmacokinetic data avoiding high doses.",
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author = "Goobie, {Susan M.} and Cladis, {Franklyn P.} and Glover, {Chris D.} and Henry Huang and Reddy, {Srijaya K.} and Fernandez, {Allison M.} and David Zurakowski and Stricker, {Paul A.} and John Fiadjoe and Codruta Soneru and Ricardo Falcon and Timothy Petersen and Courtney Kowalczyk-Derderian and Nicholas Dalesio and Stefan Budac and Neels Groenewald and Daniel Rubens and Douglas Thompson and Rheana Watts and Katherine Gentry and Iskra Ivanova and Mali Hetmaniuk and Vincent Hsieh and Michael Collins and Karen Wong and Wendy Binstock and Russell Reid and Kim Poteet-Schwartz and Heike Gries and Rebecca Hall and Jeffrey Koh and Kelsey Colpitts and Lauren Scott and Carolyn Bannister and Wai Sung and Ranu Jain and Rabail Chaudhry and Tuite, {Gerald F.} and Ernesto Ruas and Oleg Drozhinin and Lisa Tetreault and Bridget Muldowney and Karene Ricketts and Patrick Fernandez and Lisa Sohn and John Hajduk and Brad Taicher and Jessica Burkhart and Allison Wright and Veronica Busso and {the Pediatric Craniofacial Collaborative Group}",
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TY - JOUR

T1 - Safety of antifibrinolytics in cranial vault reconstructive surgery

T2 - a report from the pediatric craniofacial collaborative group

AU - Goobie, Susan M.

AU - Cladis, Franklyn P.

AU - Glover, Chris D.

AU - Huang, Henry

AU - Reddy, Srijaya K.

AU - Fernandez, Allison M.

AU - Zurakowski, David

AU - Stricker, Paul A.

AU - Fiadjoe, John

AU - Soneru, Codruta

AU - Falcon, Ricardo

AU - Petersen, Timothy

AU - Kowalczyk-Derderian, Courtney

AU - Dalesio, Nicholas

AU - Budac, Stefan

AU - Groenewald, Neels

AU - Rubens, Daniel

AU - Thompson, Douglas

AU - Watts, Rheana

AU - Gentry, Katherine

AU - Ivanova, Iskra

AU - Hetmaniuk, Mali

AU - Hsieh, Vincent

AU - Collins, Michael

AU - Wong, Karen

AU - Binstock, Wendy

AU - Reid, Russell

AU - Poteet-Schwartz, Kim

AU - Gries, Heike

AU - Hall, Rebecca

AU - Koh, Jeffrey

AU - Colpitts, Kelsey

AU - Scott, Lauren

AU - Bannister, Carolyn

AU - Sung, Wai

AU - Jain, Ranu

AU - Chaudhry, Rabail

AU - Tuite, Gerald F.

AU - Ruas, Ernesto

AU - Drozhinin, Oleg

AU - Tetreault, Lisa

AU - Muldowney, Bridget

AU - Ricketts, Karene

AU - Fernandez, Patrick

AU - Sohn, Lisa

AU - Hajduk, John

AU - Taicher, Brad

AU - Burkhart, Jessica

AU - Wright, Allison

AU - Busso, Veronica

AU - the Pediatric Craniofacial Collaborative Group

PY - 2017/3/1

Y1 - 2017/3/1

N2 - Background: Antifibrinolytic therapy significantly decreases blood loss and transfusion in pediatric cranial vault reconstructive surgery; however, concern regarding the side effects profile limits clinical use. Aims: The aim was to utilize the Pediatric Craniofacial Surgery Perioperative Registry database to identify the safety profile of antifibrinolytic therapy for cranial vault reconstructive surgery by reporting the incidence of adverse events as they relate to exposure to tranexamic acid and aminocaproic acid compared to no exposure to antifibrinolytics. Methods: The database was queried for cases of open cranial vault reconstructive surgery. Less invasive procedures such as neuro-endoscopic and spring-mediated cranioplasties were excluded. The outcomes evaluated included any perioperative neurological adverse event including seizures or seizure-like movements and thromboembolic events. Results: Thirty-one institutions reported a total of 1638 cases from 2010 to 2015. Total antifibrinolytic administration accounted for 59.5% (tranexamic acid, 36.1% and aminocaproic acid, 23.4%), with 40.5% not receiving any antifibrinolytic. The overall incidence of postoperative seizures or seizure-like movements was 0.6%. No significant difference was detected in the incidence of postoperative seizures between patients receiving tranexamic acid and those receiving aminocaproic acid [the odds ratio for seizures being 0.34 (95% confidence interval: 0.07–1.85) controlling for American Society of Anesthesia (ASA) physical class] nor in patients receiving antifibrinolytics compared to those not administered antifibrinolytics (the odds ratio for seizures being 1.02 (confidence interval 0.29–3.63) controlling for ASA physical class). One complicated patient in the antifibrinolytic group with a femoral venous catheter had a postoperative deep venous thrombosis. Conclusions: This is the first report of an incidence of postoperative seizures of 0.6% in pediatric cranial vault reconstructive surgery. There was no significant difference in postoperative seizures or seizure-like events in those patients who received the tranexamic acid or aminocaproic acid vs those that did not. This report provides evidence of the safety profile of antifibrinolytic in children having noncardiac major surgery. Caution should prevail however in using antifibrinolytic in high-risk patients. Antifibrinolytic dosage regimes should be based on pharmacokinetic data avoiding high doses.

AB - Background: Antifibrinolytic therapy significantly decreases blood loss and transfusion in pediatric cranial vault reconstructive surgery; however, concern regarding the side effects profile limits clinical use. Aims: The aim was to utilize the Pediatric Craniofacial Surgery Perioperative Registry database to identify the safety profile of antifibrinolytic therapy for cranial vault reconstructive surgery by reporting the incidence of adverse events as they relate to exposure to tranexamic acid and aminocaproic acid compared to no exposure to antifibrinolytics. Methods: The database was queried for cases of open cranial vault reconstructive surgery. Less invasive procedures such as neuro-endoscopic and spring-mediated cranioplasties were excluded. The outcomes evaluated included any perioperative neurological adverse event including seizures or seizure-like movements and thromboembolic events. Results: Thirty-one institutions reported a total of 1638 cases from 2010 to 2015. Total antifibrinolytic administration accounted for 59.5% (tranexamic acid, 36.1% and aminocaproic acid, 23.4%), with 40.5% not receiving any antifibrinolytic. The overall incidence of postoperative seizures or seizure-like movements was 0.6%. No significant difference was detected in the incidence of postoperative seizures between patients receiving tranexamic acid and those receiving aminocaproic acid [the odds ratio for seizures being 0.34 (95% confidence interval: 0.07–1.85) controlling for American Society of Anesthesia (ASA) physical class] nor in patients receiving antifibrinolytics compared to those not administered antifibrinolytics (the odds ratio for seizures being 1.02 (confidence interval 0.29–3.63) controlling for ASA physical class). One complicated patient in the antifibrinolytic group with a femoral venous catheter had a postoperative deep venous thrombosis. Conclusions: This is the first report of an incidence of postoperative seizures of 0.6% in pediatric cranial vault reconstructive surgery. There was no significant difference in postoperative seizures or seizure-like events in those patients who received the tranexamic acid or aminocaproic acid vs those that did not. This report provides evidence of the safety profile of antifibrinolytic in children having noncardiac major surgery. Caution should prevail however in using antifibrinolytic in high-risk patients. Antifibrinolytic dosage regimes should be based on pharmacokinetic data avoiding high doses.

KW - aminocaproic acid

KW - antifibrinolytics

KW - craniofacial surgery

KW - craniosynostosis

KW - safety

KW - tranexamic acid

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