Acquired Bleeding DisorderPhase 2NCT00914589
Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery
A Phase 2 study testing catridecacog in people with Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Novo Nordisk A/S at 32 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
- What is being tested?
- catridecacog
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 479 participants
- Where
- 32 sitesin 10 countries
- Study dates
- Jul 2009to Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Planned coronary artery bypass grafting (CABG) or CABG plus single heart valve replacement/repair or planned replacement/repair of a single heart valve
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
32 sites in 10 countries.
32 sites in 10 countries
United States7 sites
Novo Nordisk Investigational Site
Allentown, Pennsylvania, 18105
Novo Nordisk Investigational Site
Atlanta, Georgia, 30322-1059
Novo Nordisk Investigational Site
Durham, North Carolina, 27710
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Portland, Oregon, 97239-3098
Novo Nordisk Investigational Site
Providence, Rhode Island, 02905
Canada5 sites
Novo Nordisk Investigational Site
Montreal, H1T 1C8
Novo Nordisk Investigational Site
Ottawa, K1Y 4W7
Novo Nordisk Investigational Site
Québec, G1V 4G5
Novo Nordisk Investigational Site
Toronto, Ontario, M5B 1W8
Novo Nordisk Investigational Site
Toronto, M5G-2C4
Germany4 sites
Novo Nordisk Investigational Site
Berlin, 13353
Novo Nordisk Investigational Site
Frankfurt am Main, 60590
Novo Nordisk Investigational Site
Ludwigshafen, 67063
Novo Nordisk Investigational Site
München, 80636
Italy3 sites
Novo Nordisk Investigational Site
Bologna, 40138
Novo Nordisk Investigational Site
Milan, 20132
Novo Nordisk Investigational Site
San Donato Milanese (MI), 20097
Japan3 sites
Novo Nordisk Investigational Site
Numakunai, 020-8505
Novo Nordisk Investigational Site
Osaka, 565-8565
Novo Nordisk Investigational Site
Tokyo, 113-843
Spain3 sites
Novo Nordisk Investigational Site
Madrid, 28007
Novo Nordisk Investigational Site
Madrid, 28034
Novo Nordisk Investigational Site
Valencia, 46026
United Kingdom3 sites
Novo Nordisk Investigational Site
Cambridge, CB23 3RE
Novo Nordisk Investigational Site
Sheffield, S5 7AU
Novo Nordisk Investigational Site
Southampton, SO16 6YD
Israel2 sites
Novo Nordisk Investigational Site
Petah Tikva, 49100
Novo Nordisk Investigational Site
Ramat Gan, 52621
About this study
Official title: 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
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.
- Being tested
- catridecacog, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catridecacogDrug
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
catridecacogDrug
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
placeboDrug
Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: measured ongoing from dosing until day 7 or discharge, whichever came first
Secondary outcomes (4)
Percentage of Subjects With Thromboembolic Events
Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial
Measured: measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With rFXIII Antibody Reaction
Immunogenicity as number of subjects who manifested FXIII antibody reaction until end of trial. The percentage may be derived from the number of subjects treated with rFXIII with available antibody measurement at visit 8.
Measured: measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With Critical Adverse Events
Percentage of subjects with critical adverse events (thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism), renal dysfunction, re-operation and death) until end of trial
Measured: measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With Serious Adverse Events
Percentage of subjects with serious adverse events until end of trial.
Measured: measured from screening until 5-7 weeks post Trial Drug Administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acquired Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914589
- Sponsor's protocol ID
- NN1810-3540
- Other IDs
- JapicCTI-101078, 2008-006324-62, 2008
- Status last verified
- Jan 2017
- First submitted
- 3 Jun 2009
- Last updated
- 7 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Song HK, von Heymann C, Jespersen CM, Karkouti K, Korte W, Levy JH, Ranucci M, Saugstrup T, Sellke FW. Safe application of a restrictive transfusion protocol in moderate-risk patients undergoing cardiac operations. Ann Thorac Surg. 2014 May;97(5):1630-5. doi: 10.1016/j.athoracsur.2013.12.025. Epub 2014 Mar 19.
PubMed 24655469Karkouti K, von Heymann C, Jespersen CM, Korte W, Levy JH, Ranucci M, Sellke FW, Song HK. Efficacy and safety of recombinant factor XIII on reducing blood transfusions in cardiac surgery: a randomized, placebo-controlled, multicenter clinical trial. J Thorac Cardiovasc Surg. 2013 Oct;146(4):927-39. doi: 10.1016/j.jtcvs.2013.04.044. Epub 2013 Jun 29.
PubMed 23820174
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00914589
- Acronym / sponsor ID
- NN1810-3540
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 5 Jun 2009 (estimated)
- Results
- Posted 13 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FXIII17.5IU/Kg | Experimental | Drug: catridecacogRecombinant 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. |
| FXIII35IU/Kg | Experimental | Drug: catridecacogRecombinant 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. |
| Placebo | Placebo comparator | Drug: placeboRecombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- - Planned coronary artery bypass grafting (CABG) or CABG plus single heart valve replacement/repair or planned replacement/repair of a single heart valve
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| catridecacogSingle dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute | Drug | FXIII17.5IU/Kg |
| catridecacogSingle dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute | Drug | FXIII35IU/Kg |
| placeboSingle dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute | Drug | Placebo |
Primary outcome
Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First
Time frame: measured ongoing from dosing until day 7 or 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.
4 secondary outcomes
Percentage of Subjects With Thromboembolic Events
Time frame: measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With rFXIII Antibody Reaction
Time frame: measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With Critical Adverse Events
Time frame: measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With Serious Adverse Events
Time frame: measured from screening until 5-7 weeks post Trial Drug Administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24655469Song HK, von Heymann C, Jespersen CM, Karkouti K, Korte W, Levy JH, Ranucci M, Saugstrup T, Sellke FW. Safe application of a restrictive transfusion protocol in moderate-risk patients undergoing cardiac operations. Ann Thorac Surg. 2014 May;97(5):1630-5. doi: 10.1016/j.athoracsur.2013.12.025. Epub 2014 Mar 19.
- Derived from this study: PubMed 23820174Karkouti K, von Heymann C, Jespersen CM, Korte W, Levy JH, Ranucci M, Sellke FW, Song HK. Efficacy and safety of recombinant factor XIII on reducing blood transfusions in cardiac surgery: a randomized, placebo-controlled, multicenter clinical trial. J Thorac Cardiovasc Surg. 2013 Oct;146(4):927-39. doi: 10.1016/j.jtcvs.2013.04.044. Epub 2013 Jun 29.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
32 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing catridecacog in people with Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass, run by Novo Nordisk A/S at 32 sites in 10 countries.
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 1 inclusion and 9 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 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada, Germany, Italy, Japan and 5 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First (time frame: measured ongoing from dosing until day 7 or discharge, whichever came first). 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 NCT00914589, 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 7 Mar 2017.