NCT00914589|CompletedPhase 2ResultsDMC

Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery

A Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial on Efficacy and Safety of FXIII Replenishment With Two Different Doses of Recombinant Factor XIII Following Cardiopulmonary Bypass Surgery

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN1810-3540JapicCTI-1010782008-006324-62

Study Type

interventional

Target

479

Locations

10 countries

Sites

Timeline

RegisteredJun 2009

StartedJul 2009

CompletionFeb 2011

Brief Summary

This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.

Trial Health

On Track

Trial Health Score

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

Enrollment

479

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2009

Geographic Reach

10 countries

32 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

1.6 years study duration

First Submitted

Initial submission to the registry

June 3, 2009

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed

26 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed

3.8 years until next milestone

Results Posted

Study results publicly available

November 13, 2014

Completed

Last Updated

March 7, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

June 3, 2009

Results QC Date

September 22, 2014

Last Update Submit

January 23, 2017

Conditions

Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First
Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.
measured ongoing from dosing until day 7 or discharge, whichever came first

Secondary Outcomes (4)

Percentage of Subjects With Thromboembolic Events
measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With rFXIII Antibody Reaction
measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With Critical Adverse Events
measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With Serious Adverse Events
measured from screening until 5-7 weeks post Trial Drug Administration

Study Arms (3)

FXIII17.5IU/Kg

EXPERIMENTAL

Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.

Drug: catridecacog

FXIII35IU/Kg

EXPERIMENTAL

Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.

Drug: catridecacog

Placebo

PLACEBO COMPARATOR

Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.

Drug: placebo

Interventions

catridecacogDRUG

Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

FXIII17.5IU/Kg

placeboDRUG

Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

Placebo

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\- Planned coronary artery bypass grafting (CABG) or CABG plus single heart valve replacement/repair or planned replacement/repair of a single heart valve

You may not qualify if:

Known intolerance to protamine
Known or suspected allergy to the used antifibrinolytic agent
Refusal to receive blood or blood product
Planned surgery including the aortic arch and/or descending aorta
Planned surgery including any implantable ventricular assist device
Adult congenital heart diseases
Two or more previous cardiac surgery procedures
Any known autoimmune diseases: Collagen vascular disease (Systemic lupus erythematosus, Rheumatoid arthritis, Sjögrens syndrome) - Endocrine: hyperthyroidism (Graves disease), adrenal insufficiency, Hashimoto's thyroiditis - Neurologic: Multiple sclerosis, myasthenia gravis - Skin: pemphigous vulgaris Hematologic: Pernicious anaemia, Autoimmune haemolytic anaemia - Vasculitis - Primary or secondary antiphospholipid syndrome
Weight above 140 kg

Contact the study team to confirm eligibility.