NCT01623531

Brief Summary

The aim of the study is to show that first line treatment with concentrated fibrinogen has superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and cryoprecipitate in perioperative management of bleeding after complex cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_3

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

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
1.6 years until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 22, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

5.2 years

First QC Date

June 18, 2012

Results QC Date

February 22, 2020

Last Update Submit

May 18, 2020

Conditions

Cardiac Complication During Procedure

Keywords

Fibrinogencardiac surgeryhigh riskcardiopulmonary bypassbleedingblood transfusion

Outcome Measures

Primary Outcomes (1)

  • Cumulative Transfusion Units

    Including packed red cells, frozen plasma, platelets, cryoprecipitates

    24 hours after administration of study drug

Secondary Outcomes (16)

  • Fibrinogen Plasma Concentration (g/L)

    24h after infusion of study drug

  • Hematocrit (%)

    24h after infusion of study drug

  • Hemoglobin Concentration (g/L)

    24h after infusion of study drug

  • Platelet Count (10^3/μL)

    24h after infusion of study drug

  • Partial Thromboplastin Time (s)

    24h after infusion of study drug

  • +11 more secondary outcomes

Other Outcomes (1)

  • Overall Numbers of Patients Receiving Blood Products

    24 hours after administration of study drug

Study Arms (2)

RiaSTAP

ACTIVE COMPARATOR

Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula

Drug: Fibrinogen

Intravenous saline

PLACEBO COMPARATOR

Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula

Drug: Fibrinogen

Interventions

FibrinogenDRUG

Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)

Also known as: RiaSTAP or Haemocomplettan P
Intravenous salineRiaSTAP

Eligibility Criteria

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

You may qualify if:

  • All patients who are scheduled for elective complex cardiac surgical procedures including
  • double procedures (aortic valve replacement (AVR)+CABG, mitral valve repair/replacement (MVR)+CABG, AVR+MVR)
  • Redo-sternotomies
  • Aortic root repair +/- AVR

You may not qualify if:

  • Any known congenital or pre-existing bleeding disorder
  • pre-existing clinically significant abnormal fibrinogen level (normal: 2.5-4.79g/l)
  • severe liver disease (alanine aminotransferase or aspartate aminotransferase \> 150 U/l)
  • inability to provide informed consent
  • emergency surgery
  • pregnancy or nursing
  • age under 18 years
  • intake of anti-platelet drugs within2- 5 days preoperatively (low dose ASA is allowed)
  • allergy to concentrated fibrinogen or other components in the product
  • anemia (Hgb \< 110)
  • diagnosed deep vein thrombosis (DVT)
  • pulmonary embolism
  • acute stroke
  • acute myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CapitalDHACanada

Halifax, Nova Scotia, B3H3A7, Canada

Location

Related Publications (1)

  • Kwapisz MM, Kent B, DiQuinzio C, LeGare JF, Garnett S, Swyer W, Whynot S, Mingo H, Scheffler M. The prophylactic use of fibrinogen concentrate in high-risk cardiac surgery. Acta Anaesthesiol Scand. 2020 May;64(5):602-612. doi: 10.1111/aas.13540. Epub 2020 Jan 17.

    PMID: 31889306BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Fibrinogen

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The study was limited by a less than expected transfusion rate and the inability to reach the planned sample size.

Results Point of Contact

Title
Dr. Myron Kwapisz
Organization
Department of Anesthesia, Dalhousie University, Halifax, Canada
myron.kwapisz@nshealth.ca
+1 902 473 4326

Study Officials

  • Myron Kwapisz, MD

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

February 1, 2014

Primary Completion

March 31, 2019

Study Completion

June 30, 2019

Last Updated

May 22, 2020

Results First Posted

May 22, 2020

Record last verified: 2020-05

Locations

CA(1)