Clinical trial NCT01487837: Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.
Official title: A Phase IV, Randomized, Single Center, Parallel Group Trial of Human Fibrinogen Concentrate (Haemocomplettan) in the Treatment of Dilutional Coagulopathy During Major Pediatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Coagulation Disorders
Hemorrhage
Keywords: Fibrinogen
Blood coagulation disorders
Postoperative bleeding
Transfusions
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 57
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF \< 13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after start of surgery as compared to a trigger level of ROTEM FibTEM MCF \< 8 mm.


Eligibility criteria: Inclusion Criteria:

* Males and Females
* Age 6 months to 17 years
* Scheduled for elective scoliosis surgery or major craniofacial surgery
* Written informed consent has been obtained
* Intraoperative hypofibrinogenemia according to definition of treatment groups

Exclusion Criteria:

* Preexisting congenital or acquired coagulation disorder
* Medical history of estimated increased bleeding tendency
* Ongoing coagulation therapy
* Clinical signs or diagnosis of acute thromboembolism
* Intolerance of study drug
* Participation at another clinical trial
* Pregnant or lactating women

Primary outcomes:
measure: Total amount of transfused red cell concentrate
timeFrame: 24 hours after start of surgery
Secondary outcomes:
measure: coagulation measurements
timeFrame: 24 hours after start of surgery
measure: length of stay on PICU
timeFrame: 14 days after surgery or discharge of hospital, whatever occurs earlier
measure: Additional transfusion/blood products requirements
timeFrame: 24 hours after start of surgery
measure: Occurence of re-bleeding, surgical revision
timeFrame: 14 days after surgery or discharge of hospital, whatever occurs earlier
measure: Occurence of (severe) adverse events
timeFrame: 14 days after surgery or discharge of hospital, whatever occurs earlier
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Zurich University Children's Hospital
Study officials:
affiliation: Zurich University Children's Hospital
name: Thorsten Haas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Restin T, Schmugge M, Cushing MM, Haas T. Comparison between intraoperative bleeding score and ROTEM(R) measurements to assess coagulopathy during major pediatric surgery. Transfus Apher Sci. 2021 Oct;60(5):103191. doi: 10.1016/j.transci.2021.103191. Epub 2021 Jun 19.
citation: Haas T, Spielmann N, Restin T, Seifert B, Henze G, Obwegeser J, Min K, Jeszenszky D, Weiss M, Schmugge M. Higher fibrinogen concentrations for reduction of transfusion requirements during major paediatric surgery: A prospective randomised controlled trial. Br J Anaesth. 2015 Aug;115(2):234-43. doi: 10.1093/bja/aev136. Epub 2015 May 15.