Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000057583
Ethics application status
Approved
Date submitted
7/02/2006
Date registered
8/02/2006
Date last updated
8/02/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving blood coagulation function and reducing blood loss in infants after open heart surgery
Scientific title
Effect of nitric oxide gas and prostacyclin infusion on platelet function, coagulation activity and postoperative blood loss in paediatric cardiopulmonary bypass
Secondary ID [1] 239 0
Murdoch Children's Research Institute: MCRI 06061
Universal Trial Number (UTN)
Trial acronym
NOPCPB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemostasis during and after paediatric cardiopulmonary bypass 1021 0
Condition category
Condition code
Blood 1097 1097 0 0
Other blood disorders
Surgery 1098 1098 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare 4 anticoagulation treatments in infants during cardiac surgery with cardiopulmonary bypass:

2) anticoagulation with intravenous heparin 3 mg/kg plus 20 ppm nitric oxide (NO) gas added to the oxygenator
3) anticoagulation with intravenous heparin 3 mg/kg plus intravenous infusion of prostacyclin 2 ng/kg/min
4) anticoagulation with intravenous heparin 3 mg/kg plus combination of 20 ppm NO gas added to oxygenator and intravenous infusion of prostacyclin 2 ng/kg/min
Intervention code [1] 887 0
None
Comparator / control treatment
1) standard anticoagulation with intravenous heparin 3 mg/kg
Control group
Active

Outcomes
Primary outcome [1] 1465 0
To determine if supplementation of standard heparin anticoagulation with NO gas and/or prostacyclin in infants reduces activation of platelets and the coagulation cascade
Timepoint [1] 1465 0
Measured at the end of cardiopulmonary bypass, and preserves platelet function, measured 6 and 24 hours after the end of bypass.
Secondary outcome [1] 2625 0
To determine if supplementation of standard heparin anticoagulation with NO gas and/or prostacyclin in infants during cardiopulmonary bypass reduces postoperative blood loss.
Timepoint [1] 2625 0
Measured 6 and 24 hours after the end of bypass, or requirement for blood or blood products in Intensive Care and in the period between the end of surgery and hospital discharge.

Eligibility
Key inclusion criteria
Infants of either sex and less than one year of age having open heart surgery with cardiopulmonary bypass and who have no pre-existing haemostatic abnormality or platelet dysfunction, will be eligible for the study.
Minimum age
0 Years
Maximum age
1 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants will be excluded if 1) cardiac output is greater than 1.5 litres/min; 2) body weight is less than 3 kg; 3) they have a known abnormality of platelet function or are on anti-platelet therapy; 4) they are receiving inhaled nitric oxide gas or any nitric oxide-donor therapy; 5) they have a known blood coagulation abnormality or are on anticoagulation therapy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At the start of surgery, the perfusionist performing cardiopulmonary bypass will open sealed envelope containing information on treatment group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number allocation to one of 4 concurrent treatment groups, each containing 20 patients
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects will be blinded. For reasons of patient safety, operating theatre staff will not be blinded to type of treatment. However, staff performing laboratory tests for primary outcome and clinical data collection for secondary outcomes will be blinded to treatment type.
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1201 0
Other
Name [1] 1201 0
Murdoch Children's Research Institute
Country [1] 1201 0
Australia
Primary sponsor type
Hospital
Name
Royal Childrens Hospital and Murdoch Children's Research Institute
Address
Country
Australia
Secondary sponsor category [1] 1060 0
None
Name [1] 1060 0
None
Address [1] 1060 0
Country [1] 1060 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36217 0
Address 36217 0
Country 36217 0
Phone 36217 0
Fax 36217 0
Email 36217 0
Contact person for public queries
Name 10076 0
Dr. Stephen Horton
Address 10076 0
Cardiac Surgery Unit
Royal Childrens Hospital
Flemington Road
Parkville VIC 3052
Country 10076 0
Australia
Phone 10076 0
+61 3 93455200
Fax 10076 0
Email 10076 0
steve.horton@rch.org.au
Contact person for scientific queries
Name 1004 0
Dr. Stephen Horton
Address 1004 0
Cardiac Surgery Unit
Royal Childrens Hospital
Flemington Road
Parkville VIC 3052
Country 1004 0
Australia
Phone 1004 0
+61 3 93455200
Fax 1004 0
Email 1004 0
steve.horton@rch.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.