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HemorrhagePhase 4APPEARNCT02738190

Albumin vs. Plasma for PEdiAtric pRiming Trial

A Phase 4 study testing Albumin and Fresh Frozen Plasma in people with Hemorrhage, run by IRCCS Policlinico S. Donato at 1 site in Italy.

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

This is a randomized controlled trial that compares two different priming composition (albumin vs. fresh frozen plasma) for extracorporeal circulation of pediatric patients under 10 kg of weight. Read more about this study

Who is it for?
Any age
Conditions the study is for
Hemorrhage
What is being tested?
Albumin and Fresh Frozen Plasma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteItaly
Study dates
Jan 2015to May 2016
Phase
Phase 4
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • weight under 10 kg
  • cardiovascular surgery procedure with extracorporeal circulation
  • need for hematic priming solution
  • elective surgery
  • informed consent signed

Who cannot join

  • congenital disorders of coagulation system
  • emergency surgery

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS San Donato

    San Donato Milanese, MI, 20097

Other trials in Italy

About this study

This is a randomized controlled trial that compares two different priming composition (albumin vs. fresh frozen plasma) for extracorporeal circulation of pediatric patients under 10 kg of weight. The two approaches are both employed at the moment but there is actually no evidence on the superiority of one over the other. This study is aimed to test the hypothesis that Albumin is superior to fresh frozen plasma in terms of minor bleeding and transfusional requirements.

Read the detailed description

Extracorporeal circulation (ECC) in neonates and infants undergoing cardiac surgery for the correction or palliation of cardiac defects is characterized by temperature variation, activation of coagulation and inflammatory cascades, hemodilution.

An excessive dilution of circulating mass determines a variation in colloid-oncotic pressure (COP) that, together with hydrostatic pressure, induces liquids exchange between interstitial space and plasma. COP variation together with inflammatory response due to extracorporeal circulation and temperature variation is the main determinant of interstitial and pulmonary edema occurrence. Intravascular albumin is responsible for 80% for the COP. Golab et al. randomized a population of neonates and infants undergoing to pediatric cardiac surgery procedures in order to reach two different targets of COP through administration of different albumin amounts. His results didn't show significant differences for primary and secondary endpoints except for postoperative ventilation duration.

Trials on adult patients undergoing cardiac surgery haven't showed differences in bleeding when varying colloid solution employed. Albumin is preferred to artificial colloids due to reduced risk of anaphylactic reactions and for its capacity to maintain COP.

Hemodilution is associated to a reduction in hematocrit, platelet count, fibrinogen and other coagulation factor concentration. Solutions employed for ECC (Extracorporeal Circulation) circuits priming also contain components that could impair hemostasis.

In order to reduce the negative effects on the coagulation, many centers for pediatric surgery employ fresh frozen plasma (FFP) for priming solution. Oliver et al randomized a population of 51 cardiopathic, acyanotic children under 10 kg of weight to receive either albumin or FFP as ECC priming. The authors showed a reduction of postoperative bleeding in the group receiving FFP. No significant differences were detected in postoperative coagulation tests. Other studies with small cohorts weren't able to detect significant differences between the two regimens applied by Oliver and colleagues.

Currently the patients receiving blood priming are treated with either FFP or albumin in order to maintain a correct COP. Comparative studies are very limited by small populations and haven't yet provided definitive conclusions about eventual superiority of one regimen over another.

This is a randomized controlled trial that compares the employment of 5% Albumin (ALB group) versus Fresh Frozen Plasma (FFP group) for priming as per standard protocol of extracorporeal circulation procedure. No modifications to the normal clinical management of the patient are planned. The primary endpoint is to reduce postoperative bleeding (registered as ml/kg in the first 12 postoperative hours). The secondary endpoints are to reduce transfusional requirements for all the blood products (packed red cells, fresh frozen plasma and platelets registered as ml/kg from the beginning of the extracorporeal circulation for up to 48 hours from the termination of the surgery), ventilation support and hospital stay duration. Safety endpoint is represented by the percentage of thromboembolic complications (stroke, peripheric, pulmonary and mesenteric thromboembolisms). Both the treatments employed in this trial are to be considered standard.

Conditions
Hemorrhage
Being tested
Albumin, Fresh Frozen Plasma
Keywords
albumin, fresh frozen plasma, extracorporeal circulation, cardiovascular surgery, pediatric population
Medical subject headings
Hemorrhage

What participants receive

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

  • AlbuminDrug

    Also called Albumina, Human Albumin

    Albumin 5% added to blood priming solution

  • Fresh Frozen PlasmaBiological

    Fresh Frozen Plasma added to blood priming solution

Study groups in NCT02738190
Study groupRoleWhat they receive
AlbuminActive comparator5% Albumin to be added to the priming solution composed of concentrated red cells to reach a target of 28-30% hematocrit and albumin to reach the standard volume administered to these patients (400 ml)
Receives: Drug: Albumin
Fresh Frozen PlasmaActive comparatorFresh Frozen Plasma to be added to the priming solution composed of concentrated red cells to reach a target of 28-30% hematocrit and plasma to reach the standard volume administered to these patients (400 ml)
Receives: Biological: Fresh Frozen Plasma

What is being measured

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

  1. Volume of postoperative bleeding

    Postoperative bleeding in ml/kg, as measured by chest drainage

    Measured: 24 hours

Secondary outcomes (4)

  1. Number of units of blood components transfused

    All kind of blood products (packed red cells, fresh frozen plasma, platelet concentrate) transfused from the extracorporeal circulation beginning

    Measured: 48 hours

  2. Hours on artificial ventilation

    Artificial ventilation duration from the ICU admission till extubation

    Measured: hours until extubation, an average of 72 hours

  3. Days of hospital stay

    Hospital stay duration from ICU admission till discharge

    Measured: days until discharge, an average of 10 days

  4. Thromboembolic complications

    All kind of thromboembolic complication (peripheric, pulmonary, mesenteric) from ICU admission till discharge from the hospital

    Measured: Postoperative hospital stay until discharge, an average of 10 days

Timeline

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

  1. First posted14 Apr 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02738190
Sponsor's protocol ID
APPEAR
Acronym
APPEAR
Status last verified
Aug 2016
First submitted
15 Mar 2016
Last updated
30 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Weil MH, Henning RJ, Puri VK. Colloid oncotic pressure: clinical significance. Crit Care Med. 1979 Mar;7(3):113-6. doi: 10.1097/00003246-197903000-00006. No abstract available.

    PubMed 436426

  • Golab HD, Scohy TV, de Jong PL, Kissler J, Takkenberg JJ, Bogers AJ. Relevance of colloid oncotic pressure regulation during neonatal and infant cardiopulmonary bypass: a prospective randomized study. Eur J Cardiothorac Surg. 2011 Jun;39(6):886-91. doi: 10.1016/j.ejcts.2010.09.040. Epub 2010 Nov 5.

    PubMed 21055963

  • Chandler WL. Effects of hemodilution, blood loss, and consumption on hemostatic factor levels during cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2005 Aug;19(4):459-67. doi: 10.1053/j.jvca.2004.11.046.

    PubMed 16085250

  • Oliver WC Jr, Beynen FM, Nuttall GA, Schroeder DR, Ereth MH, Dearani JA, Puga FJ. Blood loss in infants and children for open heart operations: albumin 5% versus fresh-frozen plasma in the prime. Ann Thorac Surg. 2003 May;75(5):1506-12. doi: 10.1016/s0003-4975(02)04991-3.

    PubMed 12735570

  • McCall MM, Blackwell MM, Smyre JT, Sistino JJ, Acsell JR, Dorman BH, Bradley SM. Fresh frozen plasma in the pediatric pump prime: a prospective, randomized trial. Ann Thorac Surg. 2004 Mar;77(3):983-7; discussion 987. doi: 10.1016/j.athoracsur.2003.09.030.

    PubMed 14992912

  • Bianchi P, Cotza M, Beccaris C, Silvetti S, Isgro G, Pome G, Giamberti A, Ranucci M; Surgical and Clinical Outcome REsearch (SCORE) group. Early or late fresh frozen plasma administration in newborns and small infants undergoing cardiac surgery: the APPEAR randomized trial. Br J Anaesth. 2017 May 1;118(5):788-796. doi: 10.1093/bja/aex069.

    PubMed 28510741

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Albumin and Fresh Frozen Plasma in people with Hemorrhage, run by IRCCS Policlinico S. Donato at 1 site in Italy.

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 5 inclusion and 2 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 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Volume of postoperative bleeding (time frame: 24 hours). 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 NCT02738190, which also lists 6 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 30 Aug 2016.

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