NCT01487837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

2.8 years

First QC Date

December 5, 2011

Last Update Submit

October 24, 2014

Conditions

Blood Coagulation DisordersHemorrhage

Keywords

FibrinogenBlood coagulation disordersPostoperative bleedingTransfusions

Outcome Measures

Primary Outcomes (1)

  • Total amount of transfused red cell concentrate

    24 hours after start of surgery

Secondary Outcomes (5)

  • coagulation measurements

    24 hours after start of surgery

  • length of stay on PICU

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

  • Additional transfusion/blood products requirements

    24 hours after start of surgery

  • Occurence of re-bleeding, surgical revision

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

  • Occurence of (severe) adverse events

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

Study Arms (2)

Fibrinogen if FibTEM < 8 mm

ACTIVE COMPARATOR

Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF \< 8 mm

Drug: Human fibrinogen concentrate

Fibrinogen if FibTEM < 13 mm

EXPERIMENTAL

Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF \< 13 mm

Drug: Human fibrinogen concentrate

Interventions

Human fibrinogen concentrateDRUG

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

Also known as: Haemocomplettan P, CSL Behring
Fibrinogen if FibTEM < 13 mmFibrinogen if FibTEM < 8 mm

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zurich University Children's Hospital

Zurich, 8032, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 34215519DERIVED

  • 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.

    PMID: 25982134DERIVED

MeSH Terms

Conditions

Blood Coagulation DisordersHemorrhagePostoperative Hemorrhage

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • Thorsten Haas, MD

    Zurich University Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Study Start

January 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 27, 2014

Record last verified: 2014-10

Locations

CH(1)