NCT01124981

Brief Summary

Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy. Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events remains unknown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2011

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

May 10, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

3.8 years

First QC Date

May 10, 2010

Last Update Submit

December 15, 2014

Conditions

Fibrinogen Deficiency in Complex Cardiac Surgery

Keywords

Fibrinogen concentrateCoagulopathy

Outcome Measures

Primary Outcomes (1)

  • To determine whether fibrinogen concentrate infusion reduces perioperative blood loss.

    Perioperative blood loss measured as blood loss in ml between infusion of study medication and closure of chest.

    within 12 hours.

Secondary Outcomes (3)

  • To determine whether fibrinogen concentrate infusion reduces postoperative blood loss.

    within 24 hours after infusion of study medication.

  • To determine whether fibrinogen concentrate infusion reduces postoperative transfusion of blood products during elective complex cardiac surgery.

    within 24 hours after infusion of study medication.

  • To determine whether fibrinogen concentrate infusion is safe and well-tolerated.

    30 days

Study Arms (2)

Albumin

PLACEBO COMPARATOR
Drug: Human albumin (Placebo)

Haemocomplettan® P

EXPERIMENTAL
Drug: Haemocomplettan® P

Interventions

Haemocomplettan® PDRUG

Dosing of study medication will be individually determined based on plasma fibrinogen concentrations (measured with Clauss method during the reperfusion period on CPB) and body weight. Intravenous infusion within 10 minutes.

Also known as: Fibrinogen concentrate
Haemocomplettan® P
Human albumin (Placebo)DRUG

Human albumin with concentration 200g/L. The study bottles of 50 mL will be diluted with saline and will contain 2g in total. This concentration resembles the total protein load in the bottles with Haemocomplettan® P.

Also known as: Albumin
Albumin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eighteen years of age or older.
  • Undergoing elective complex cardiac surgery.
  • Understood and willingly given written informed consent.
  • Experience clinically relevant non-surgical microvascular bleeding following removal of cardiopulmonary bypass.

You may not qualify if:

  • Positive pregnancy test, pregnancy or lactation.
  • Undergoing an emergency operation.
  • Proof or suspicion of a congenital or acquired coagulation disorder.
  • Clopidogrel use in the 5 days preceding surgery.
  • INR \>1.4 if on coumadin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department Anesthesiology & Intensive Care

Zwolle, Overijssel, 8011 JW, Netherlands

Location

Department of Cardiothoracic Anaesthesia and Intensive Care Isala Klinieken

Zwolle, Overijssel, 8011 JW, Netherlands

Location

Related Publications (1)

  • Bilecen S, de Groot JA, Kalkman CJ, Spanjersberg AJ, Brandon Bravo Bruinsma GJ, Moons KG, Nierich AP. Effect of Fibrinogen Concentrate on Intraoperative Blood Loss Among Patients With Intraoperative Bleeding During High-Risk Cardiac Surgery: A Randomized Clinical Trial. JAMA. 2017 Feb 21;317(7):738-747. doi: 10.1001/jama.2016.21037.

    PMID: 28241354DERIVED

Related Links

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

FibrinogenSerum Albumin, HumanAlbumins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Acute-Phase ProteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBlood Coagulation FactorsProtein PrecursorsBiological FactorsSerum Albumin

Study Officials

  • Arno P Nierich, MD, PhD.

    Isala

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 18, 2010

Study Start

February 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

NL(2)