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Evaluation of therapeutic safety and efficacy of tranexamic acid or aprotinin in absolute blood loss and transfusion in pediatric patients undergoing craniosynostosis surgery

Protocol summary

Study aim
 To determine average absolute blood loss in each three groups and comparison between groups
Design
In the current randomized controlled trial, 90 eligible pediatric patients with craniosynostosis will be randomly divided into 3 intervention groups to receive aprotinin 35000 KIU/kg with 10000 KIU/kg/h infusion rate intraoperative, tranexamic acid 50 mg/kg intravenously intraoperative, or no intervention. The absolute blood loss and transfusion will be assessed for all patients both intraoperative, 24 hours, and 48 hours postoperative.
Settings and conduct
A randomized, single center, parallel, double blind, superiority controlled trial to compare therapeutic safety and efficacy of tranexamic acid or aprotinin in absolute blood loss and transfusion in pediatric patients undergoing craniosynostosis surgery
Participants/Inclusion and exclusion criteria
Pediatric patients between ages 2 months to 2 years, of both sexes, with single of multiple suture craniosynostosis and hemoglobin level of more than 13 mg/dl, without history of coagulopathies, hemoglobinopathies, abnormal renal function tests, allergy to intervention drugs will be included in this study..
Intervention groups
Tranexamic acid, Aprotinin, No intervention
Main outcome variables
Primary objectives: Intraoperative and postoperative blood loss and blood transfusion and intervention-related mortality will be considered as primary outcomes Secondary objectives: Mean difference of immediate, 24-hour, and 48-hour postoperative Hb and Hct subtracted from preoperative levels, coagulation test abnormality, diffuse intravascular coagulation (DIC), acute renal failure, acute tubular necrosis, all case mortality, and adverse events will be considered as secondary objectives.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200705048023N1
Registration date: 2020-07-07, 1399/04/17
Registration timing: prospective

Last update: 2020-07-07, 1399/04/17
Update count: 0
Registration date
2020-07-07, 1399/04/17
Registrant information
Name
Zahra Ebrahim Soltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4421 0127
Email address
zahra_esoltani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic safety and efficacy of tranexamic acid or aprotinin in absolute blood loss and transfusion in pediatric patients undergoing craniosynostosis surgery
Public title
Effect of tranexamic acid and aprotinin in absolute blood loss in pediatric neurosurgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
 Age between 2 months and 2 years, both sex  Single or multi-suture craniosynostosis including metopic, sagittal, unicoronal, and bicoronal synostoses  Syndromic or non-syndromic craniosynostosis  Hemoglobin level of equal or more than 13 mg/dl  Patient’s parents or legal guardian agreement to sign the informed consent form
Exclusion criteria:
 Indication for endoscopic craniosynostosis surgery  History of coagulopathies or hemoglobinopathies in patient or first degree family (hemophilia, abnormal PT, PTT, INR tests, afibrinogenemia, congenital coagulatory factor deficiencies)  Craniofacial surgeries  Craniosynostosis recurrence  Secondary craniosynostosis  Abnormal renal function tests including abnormal BUN and Cr for age or family history of hereditary renal disease as polycystic kidney  Allergy to Aprotinin, tested 30 minutes pre operation with 0.1 dose of therapeutic dose  Congenital heart disease
Age
From 2 months old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: The order of study interventions would be determined using 6-block computer-based randomization master list. (http://randomization.ir) Random allocation: The intervention for each patient would be determined accordingly to randomization cards and their orders would be accordingly to randomization master list. Concealment: The randomization cards would be placed in opaque pockets and only in time of random allocation, one pocket would be opened for one patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
each patient will allocated to one of 3 groups randomly. the randomization will performed by a separate research team (without informing the surgeon, anesthesiologist and personnel of operation room. the prescription of the drug will performed by anesthesiology service (without informing the surgeon from the intervention group). the assessment during surgery will done by surgical service and the assessment after surgery will performed by ICU service(without informing the surgeon from the intervention group).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Children Medical Center
Street address
Children Medical Center, Qarib street
City
tehran
Province
Tehran
Postal code
1419733151
Approval date
2020-07-04, 1399/04/14
Ethics committee reference number
IR.TUMS.CHMC.REC.1399.061

Health conditions studied

1

Description of health condition studied
craniosynostosis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Intraoperative and postoperative blood loss and blood transfusion and intervention-related mortality will be considered as primary outcomes
Timepoint
during the surgery, 4 and 24 hours after surgery
Method of measurement
The amount of blood loss as the result of surgery, intraoperative or postoperative.Estimation or calculation with formula

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Tranexamic acid
Category
Treatment - Drugs

2

Description
Intervention group: Aprotinin
Category
Treatment - Drugs

3

Description
Control group: No intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Children Medical Center (CMC)
Full name of responsible person
Zahra Ebrahim soltani
Street address
Qarib street
City
tehran
Province
Tehran
Postal code
141733151
Phone
+98 21 6149
Email
zahra_esoltani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mohammad reza monazam
Street address
Keshavarz blvd, pour-sina street
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 6641 9084
Email
irsw-leadinghouse@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Ebrahim soltani
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
no 12
City
tehran
Province
Tehran
Postal code
1463773117
Phone
+98 21 4421 0127
Email
zahra_esoltani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Ebrahim soltani
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
no 12
City
tehran
Province
Tehran
Postal code
1463773117
Phone
+98 21 4421 0127
Email
zahra_esoltani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Ebrahim soltani
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
no 12
City
tehran
Province
Tehran
Postal code
1463773117
Phone
+98 21 4421 0127
Email
zahra_esoltani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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