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Clinical Trials/EUCTR2014-000177-39-IT
EUCTR2014-000177-39-IT
Active, not recruiting
Phase 1

Albumin vs. Plasma for PEdiAtric pRiming (APPEAR) trial - APPEAR

IRCCS Policlinico San Donato0 sitesMarch 21, 2014
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ConditionsCongenital cardiac diseases needing surgical correction requiring intervention with extracorporeal circulationTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
DrugsAlbumin 5%

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Congenital cardiac diseases needing surgical correction requiring intervention with extracorporeal circulation
Sponsor
IRCCS Policlinico San Donato
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 21, 2014
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Weight lower than 10 kg
  • •Cardiac surgery requiring cardiopulmonary bypass
  • •Need for hematic priming
  • •Elective surgery
  • •Informed consent signed by the parents or people delegated with parental authority
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 80
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • •Congenital diseases of hemostasis and coagulation
  • •Emergency surgery

Outcomes

Primary Outcomes

Not specified

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