Clinical trial • Not applicable • Haematology

PLASMA for Congenital heart disease | Perioperative coagulation abnormalities

Not applicable trial of PLASMA for Congenital heart disease | Perioperative coagulation abnormalities.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Congenital heart disease | Perioperative coagulation abnormalities
Trial Stage
Not applicable
Drug Modality
Peptide/protein/enzyme
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
04-09-2024
First CTIS Authorization Date
23-09-2024

Trial design

open-label, plasma (intravenous infusion) compared with omniplasma 45-70 mg/ml solution for infusion (human plasma protein, infusion). max total dose reported as 3500 ml for both products.-controlled Not applicable trial across 1 site in Netherlands.

Open Label
Yes
Comparator
PLASMA (intravenous infusion) compared with Omniplasma 45-70 mg/ml solution for infusion (human plasma protein, infusion). Max total dose reported as 3500 ml for both products.
Target Sample Size
120

Eligibility

Recruits 120 paediatric patients.

Vulnerable Population
Trial involves paediatric participants; 'isVulnerablePopulationSelected' is false. Inclusion criterion: 'Informed consent'. Subject information and informed consent form available (document L1_SIS and ICF 202100044422). No details on assent or additional protections provided.

Inclusion criteria

  • {"criterion_text":"- Informed consent"}
  • {"criterion_text":"- Cardiac surgery with the use of CPB"}
  • {"criterion_text":"- Group 1A and Group 2A children < 1 year old"}
  • {"criterion_text":"- Group 1B and Group 2B Glenn / Fontan surgery"}

Exclusion criteria

  • {"criterion_text":"- No informed consent"}
  • {"criterion_text":"- Cardiac surgery without the use of CPB"}
  • {"criterion_text":"- Preoperative known coagulation disorders"}
  • {"criterion_text":"- Known allergy for FFP or Omniplasma"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Primary outcome involves the difference of coagulation variables measured just after surgery between FFP or Omniplasma use. The coagulation variables of interest are protein C activity, protein S activity, α2-antiplasmin, antithrombin, plasminogen, Hb, thrombocyte count, ROTEM, aPTT, PT and fibrinogen.","definition_or_measurement_approach":"Difference in coagulation variables measured just after surgery between FFP and Omniplasma use; coagulation variables measured include protein C activity, protein S activity, α2-antiplasmin, antithrombin, plasminogen, haemoglobin (Hb), thrombocyte count, ROTEM, aPTT, PT and fibrinogen."}

Recruitment

Planned Sample Size
120
Recruitment Window Months
71
Consent Approach
Informed consent required; 'Informed consent' listed as an inclusion criterion. Subject information and informed consent form available (document L1_SIS and ICF 202100044422). No details provided on assent procedures or languages available.

Geography

Total Number Of Sites
1
Total Number Of Participants
120

Netherlands

Earliest CTIS Part Ii Submission Date
17-09-2024
Latest Decision Or Authorization Date
23-09-2024
Processing Time Days
6
Number Of Sites
1
Number Of Participants
120

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Anesthesiology
Contact Person Name
I.I. de Liefde
Contact Person Email
i.deliefde@erasmusmc.nl
Number Of Participants
120

Sponsor

Primary sponsor

Full Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
PLASMA
Active Substance
PLASMA
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
No marketing authorisation listed
Maximum Dose
3500 ml
Investigational Product Name
Omniplasma 45-70 mg/ml oplossing voor infusie
Active Substance
HUMAN PLASMA PROTEIN
Modality
Peptide/protein/enzyme
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (marketing authorisation RVG 25407 listed for Omniplasma)
Maximum Dose
3500 ml

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