Liver SurgeryPhase 4NCT02050841

Octaplas Pediatric Plasma Replacement Trial

A Phase 4 study testing octaplas in people with Liver Surgery and Liver Dysfunction, run by Octapharma at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors. Replacement of multiple coagulation factors in pediatric patients with acquired deficiencies due to liver disease and/or in pediatric patients… Read more about this study

Who is it for?: Ages Up to 16 years
Conditions the study is for: Liver Surgery, Liver Dysfunction, Coagulopathy
What is being tested?: octaplas
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 4 sitesUnited States
Study dates: Dec 2014to 4 Dec 2017
Phase: Phase 4
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 Up to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patient requiring liver or cardiac surgery and/or patient with liver dysfunction associated with coagulopathy in whom replacement of multiple coagulation factors is required.
Voluntarily given, written and signed informed consent by the patient's legal representative(s) or guardian(s). Children deemed old enough by the Investigator/institution to understand the risks and benefits of the study should also be made aware of the risks/benefits of the study and provide written assent.
Male or female patient ≤ 16 years of age.

Who cannot join

Patient with known homozygous congenital deficiency of protein S.
Patient has a history of hypersensitivity reaction to blood or plasma-derived products or to any excipient of the investigational product.
Patient has an already known IgA (Immunoglobulin A) deficiency with documented antibodies against IgA.
Patient has a congenital factor deficiency or platelet disorder requiring plasma treatment.
Patient is currently participating in another study investigating a new drug product or another interventional clinical study that may impact coagulation factors or has participated during the last three (3) months.
Patient received FFP (Fresh Frozen Plasma), FP24 (Plasma frozen within 24 hours of collection) or any other plasma product other than Octaplas within the last 72 hours (cryoprecipitate and albumin are not exclusionary) prior to first Octaplas infusion.

Show all 12Show fewer

Patient is on ECMO (Extracorporeal Membrane Oxygenation) when plasma is ordered by the treating physician for the first infusion episode.
Patient is pregnant.
Patient is predicted to require massive blood transfusion defined as more than 40 mL per kilogram of all blood products in a 24-hour period
Patient is receiving plasma exchange, therapeutic plasma exchange (TPE) or plasmapheresis.
Patient is a premature neonate defined as less than 37 weeks gestation.
Cardiac surgery patients who develop the need for plasma replacement greater than 72 hours after the end of the associated cardiac surgery and do not have coagulopathy due to hepatic dysfunction.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Octapharma Research Site
Atlanta, Georgia, 30322
Octapharma Research Site
Birmingham, Alabama, 35233
Octapharma Research Site
Minneapolis, Minnesota, 55455
Octapharma Research Site
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors.

Conditions: Liver Surgery, Liver Dysfunction, Coagulopathy, Cardiac Surgery
Being tested: octaplas
Keywords: Pediatric, patients, replacement, coagulation factors, plasma, s/d plasma, Octaplas, plasma replacement
Medical subject headings: Liver Diseases, Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

octaplasBiological
Octaplas S/D Plasma

Study groups in NCT02050841
Study group	Role	What they receive
Octaplas	Experimental	Qualified patients will receive Octaplas as per protocol. Receives: Biological: octaplas

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Measured: up to 6 days
Monitoring of Clinically Significant Changes in White Blood Cells
Assesses Pre- and Post-infusion for Infusion Episode 1
Measured: up to 6 days
Monitoring of Clinically Significant Changes in Red Blood Cells
Assesses Pre- and Post-infusion for Infusion Episode 1
Measured: up to 6 days
Monitoring of Clinically Significant Changes in Hemoglobin
Assesses Pre- and Post-infusion for Infusion Episode 1
Measured: up to 6 days
Monitoring of Clinically Significant Changes in Hematocrit
Assesses Pre- and Post-infusion for Infusion Episode 1
Measured: up to 6 days
Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV)
Assesses Pre- and Post-infusion for Infusion Episode 1
Measured: up to 6 days
Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH)
Assesses Pre- and Post-infusion for Infusion Episode 1
Measured: up to 6 days
Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC)
Assesses Pre- and Post-infusion for Infusion Episode 1
Measured: up to 6 days
Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW)
Assesses Pre- and Post-infusion for Infusion Episode 1
Measured: up to 6 days
Monitoring of Clinically Significant Changes in Platelets
Assesses Pre- and Post-infusion for Infusion Episode 1
Measured: up to 6 days

Secondary outcomes (11)

Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)
This hemostatic parameter is figured out in the lab and helps to diagnose a bleeding disorder or excessive clotting disorder. The change of INR before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below.
Measured: up to 6 days
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)
This hemostatic parameter is figured out in the lab and measures the time it takes for your blood to clot (the higher the PT the longer it takes your blood to clot). The change of PT before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below.
Measured: up to 6 days
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).
TEG and ROTEM are methods of testing the efficiency of blood coagulation. The results were compared by looking at potential trends from TEG and ROTEM between pre-infusion vs post-infusion time points.
Measured: up to 6 days
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
aPTT measures the length of time (in seconds) that it takes for clotting to occur in a test cube. The higher the number of seconds the longer it takes the blood to clot. The changes between pre - and post infusion were analyzed
Measured: up to 6 days
Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.
Normal infusion: Replacement of multiple clotting factors Bypass priming: Limit hemodilution and reduce transfusion requirements Bypass warming up: Rewarm patients suffering from hypothermia during the surgery process
Measured: up to 6 days
Medically Significant Changes in Blood Pressure
Measured: up to 6 days
Medically Significant Changes in Heart Rate
Measured: up to 6 days
Medically Significant Changes in Respiratory Rate
Measured: up to 6 days
Medically Significant Changes in Oxygen Saturation
Measured: up to 6 days
Medically Significant Changes in Body Temperature
Measured: up to 6 days
Count of Investigator's Assessment of Overall Safety Observed for Patients by Category (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor')
Measured: up to 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 20144 Dec 2017

First posted31 Jan 2014 (estimated)
Study startDec 2014
Primary completion4 Dec 2017
Study completion4 Dec 2017

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 (1)Papers the sponsor has linked to this study.
Other trials for Liver SurgeryStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02050841
Sponsor's protocol ID: LAS-212
Status last verified: Jun 2020
First submitted: 21 Jan 2014
Last updated: 23 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes

Publications

Spinella PC, Borasino S, Alten J. Solvent/Detergent-Treated Plasma in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors: An Open-Label, Multicenter, Post-marketing Study. Front Pediatr. 2020 Sep 17;8:572. doi: 10.3389/fped.2020.00572. eCollection 2020.
PubMed 33042916

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Liver Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors.
ClinicalTrials.gov ID: NCT02050841
Acronym / sponsor ID: LAS-212
Conditions: Liver Surgery, Liver Dysfunction, Coagulopathy, Cardiac Surgery
Keywords: Pediatric, patients, replacement, coagulation factors, plasma, s/d plasma, Octaplas, plasma replacement
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: OctapharmaIndustry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: 4 Dec 2017 (actual)
Study completion: 4 Dec 2017 (actual)
First posted: 31 Jan 2014 (estimated)
Results: Posted 25 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Octaplas	Experimental	Biological: octaplasQualified patients will receive Octaplas as per protocol.

Who may qualify

Ages: Up to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Patient requiring liver or cardiac surgery and/or patient with liver dysfunction associated with coagulopathy in whom replacement of multiple coagulation factors is required.
Voluntarily given, written and signed informed consent by the patient's legal representative(s) or guardian(s). Children deemed old enough by the Investigator/institution to understand the risks and benefits of the study should also be made aware of the risks/benefits of the study and provide written assent.
Male or female patient ≤ 16 years of age.

Key exclusion criteria (12 listed)

Patient with known homozygous congenital deficiency of protein S.
Patient has a history of hypersensitivity reaction to blood or plasma-derived products or to any excipient of the investigational product.
Patient has an already known IgA (Immunoglobulin A) deficiency with documented antibodies against IgA.
Patient has a congenital factor deficiency or platelet disorder requiring plasma treatment.
Patient is currently participating in another study investigating a new drug product or another interventional clinical study that may impact coagulation factors or has participated during the last three (3) months.

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
octaplasOctaplas S/D Plasma	Biological	Octaplas

Primary outcome

Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Time frame: up to 6 days
Monitoring of Clinically Significant Changes in White Blood Cells
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Red Blood Cells
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Hemoglobin
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Hematocrit
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV)
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH)
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC)
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW)
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Platelets
Time frame: up to 6 days
Assesses Pre- and Post-infusion for Infusion Episode 1

11 secondary outcomes

Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)
Time frame: up to 6 days
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)
Time frame: up to 6 days
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).
Time frame: up to 6 days
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
Time frame: up to 6 days
Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.
Time frame: up to 6 days
Medically Significant Changes in Blood Pressure
Time frame: up to 6 days
Medically Significant Changes in Heart Rate
Time frame: up to 6 days
Medically Significant Changes in Respiratory Rate
Time frame: up to 6 days
Medically Significant Changes in Oxygen Saturation
Time frame: up to 6 days
Medically Significant Changes in Body Temperature
Time frame: up to 6 days
Count of Investigator's Assessment of Overall Safety Observed for Patients by Category (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor')
Time frame: up to 6 days

Results and safety

Results posted to the registry on 25 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Octaplas	50	49

Primary outcome: Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)

Time frame: up to 6 days. Number. Unit: participants

Measure	Octaplas n = 50
Any SAE	5
Any SAE related to Octaplas	0
Any ADR	0
Any ADR, SAE, HFE TEE, or TE leading to withdrawal	0
Any ADR, SAE, HFE, TEE, or TE leading to death	1
Any study death related to Octaplas	0

Primary outcome: Monitoring of Clinically Significant Changes in White Blood Cells

Time frame: up to 6 days. Median (Full Range). Unit: 10^3/µL

Measure	Children >2 Years n = 13	Infants ≤2 Years n = 37
Value	5.3 (-4.7 to 28.3)	2.05 (-12.3 to 9.3)

Primary outcome: Monitoring of Clinically Significant Changes in Red Blood Cells

Time frame: up to 6 days. Median (Full Range). Unit: 10^6/µL

Measure	Children >2 Years n = 13	Infants ≤2 Years n = 37
Value	-0.34 (-1.4 to 0.6)	-0.06 (-1.8 to 1.8)

Primary outcome: Monitoring of Clinically Significant Changes in Hemoglobin

Time frame: up to 6 days. Median (Full Range). Unit: g/dL

Measure	Children >2 Years n = 13	Infants ≤2 Years n = 37
Value	-0.70 (-3.9 to 2.7)	0.80 (-4.6 to 5.2)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for each participant over the course of 6 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Octaplas	5 of 50 (10%)	0 of 50 (0%)	1 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33042916Spinella PC, Borasino S, Alten J. Solvent/Detergent-Treated Plasma in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors: An Open-Label, Multicenter, Post-marketing Study. Front Pediatr. 2020 Sep 17;8:572. doi: 10.3389/fped.2020.00572. eCollection 2020.

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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.

Wolfgang Frenzel study director

International Medical Director

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing octaplas in people with Liver Surgery and Liver Dysfunction, run by Octapharma at 4 sites in United States.

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 3 inclusion and 12 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 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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?

Yes. Results are posted in the registry (first posted 25 Mar 2019). 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?

Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events) (time frame: up to 6 days). The study lists 10 primary outcomes in all. 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 NCT02050841, which also lists 1 linked publication.

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 23 Jun 2020.