Skip to main content
OpenTrials
Completed

NCT Number: NCT01487837

Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Coagulation Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zurich University Children's Hospital

Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human fibrinogen concentrate

Drug

Administration of human fibrinogen concentrate (30 mg / kg bw) over 15 min Repetition if hourly intraoperative ROTEM measurements revealed hypofibrinogenemia according to treatment group definition

Other names: Haemocomplettan P, CSL Behring

Primary outcomes

  1. Total amount of transfused red cell concentrate

    Time frame: 24 hours after start of surgery

Secondary outcomes

  1. coagulation measurements

    Time frame: 24 hours after start of surgery

    influence on viscoelastic coagulation measurements (ROTEM), plasmatic coagulation testing, FXIII levels, and endogenous thrombin potential

  2. length of stay on PICU

    Time frame: 14 days after surgery or discharge of hospital, whatever occurs earlier

  3. Additional transfusion/blood products requirements

    Time frame: 24 hours after start of surgery

  4. Occurence of re-bleeding, surgical revision

    Time frame: 14 days after surgery or discharge of hospital, whatever occurs earlier

  5. Occurence of (severe) adverse events

    Time frame: 14 days after surgery or discharge of hospital, whatever occurs earlier

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 7, 2011
Registry last updated
Oct 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.