Blood Coagulation DisordersPhase 4NCT01487837
Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.
A Phase 4 study testing Human fibrinogen concentrate in people with Blood Coagulation Disorders and Hemorrhage, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Blood Coagulation Disorders, Hemorrhage
- What is being tested?
- Human fibrinogen concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Oct 2014
- Phase
- Phase 4
- 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 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Conditions
- Blood Coagulation Disorders, Hemorrhage
- Being tested
- Human fibrinogen concentrate
- Keywords
- Fibrinogen, Blood coagulation disorders, Postoperative bleeding, Transfusions
- Medical subject headings
- Blood Coagulation Disorders, Hemorrhage, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human fibrinogen concentrateDrug
Also called Haemocomplettan P, CSL Behring
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
| Study group | Role | What they receive |
|---|---|---|
| Fibrinogen if FibTEM < 8 mm | Active comparator | Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 8 mm Receives: Drug: Human fibrinogen concentrate |
| Fibrinogen if FibTEM < 13 mm | Experimental | Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 13 mm Receives: Drug: Human fibrinogen concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of transfused red cell concentrate
Measured: 24 hours after start of surgery
Secondary outcomes (5)
coagulation measurements
influence on viscoelastic coagulation measurements (ROTEM), plasmatic coagulation testing, FXIII levels, and endogenous thrombin potential
Measured: 24 hours after start of surgery
length of stay on PICU
Measured: 14 days after surgery or discharge of hospital, whatever occurs earlier
Additional transfusion/blood products requirements
Measured: 24 hours after start of surgery
Occurence of re-bleeding, surgical revision
Measured: 14 days after surgery or discharge of hospital, whatever occurs earlier
Occurence of (severe) adverse events
Measured: 14 days after surgery or discharge of hospital, whatever occurs earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood Coagulation DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thorsten Haas, MD, Principal investigator, Zurich University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487837
- Sponsor's protocol ID
- KEK-ZH-Nr. 2011-0440
- Status last verified
- Oct 2014
- First submitted
- 5 Dec 2011
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34215519Haas 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.
PubMed 25982134
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01487837
- Acronym / sponsor ID
- KEK-ZH-Nr. 2011-0440
- Conditions
- Blood Coagulation Disorders, Hemorrhage
- Keywords
- Fibrinogen, Blood coagulation disorders, Postoperative bleeding, Transfusions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrinogen if FibTEM < 8 mm | Active comparator | Drug: Human fibrinogen concentrateAdministration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 8 mm |
| Fibrinogen if FibTEM < 13 mm | Experimental | Drug: Human fibrinogen concentrateAdministration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 13 mm |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human fibrinogen concentrateAlso: Haemocomplettan P, CSL BehringAdministration of human fibrinogen concentrate (30 mg / kg bw) over 15 min Repetition if hourly intraoperative ROTEM measurements revealed hypofibrinogenemia according to treatment group definition | Drug | Fibrinogen if FibTEM < 13 mm, Fibrinogen if FibTEM < 8 mm |
Primary outcome
Total amount of transfused red cell concentrate
Time frame: 24 hours after start of surgery
5 secondary outcomes
coagulation measurements
Time frame: 24 hours after start of surgery
length of stay on PICU
Time frame: 14 days after surgery or discharge of hospital, whatever occurs earlier
Additional transfusion/blood products requirements
Time frame: 24 hours after start of surgery
Occurence of re-bleeding, surgical revision
Time frame: 14 days after surgery or discharge of hospital, whatever occurs earlier
Occurence of (severe) adverse events
Time frame: 14 days after surgery or discharge of hospital, whatever occurs earlier
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
- Derived from this study: PubMed 34215519Restin 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.
- Derived from this study: PubMed 25982134Haas 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.
Related trials for Blood Coagulation Disorders
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten Haas, MD principal investigator
Zurich University Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human fibrinogen concentrate in people with Blood Coagulation Disorders and Hemorrhage, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 5 inclusion and 7 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 Oct 2014. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total amount of transfused red cell concentrate (time frame: 24 hours after start of surgery). 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 NCT01487837, which also lists 2 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 Oct 2014.