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Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

Primary Purpose

Craniosynostoses

Status
Suspended
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Tranexamic Acid
Tranexamic Acid
Saline Placebo
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craniosynostoses focused on measuring Blood Loss and Transfusion, Craniosynostoses, Tranexamic Acid, Children

Eligibility Criteria

2 Months - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants aged 2 months to 2 years undergoing anterior cranial vault reconstruction

Exclusion Criteria:

  • Known bleeding disorder as this may increase the risk of bleeding
  • Current antifibrinolytic therapy as these patients may bleed less
  • Patient or family history of thromboembolic disease as there may be potential risk of thrombosis
  • Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding
  • Known allergy to TXA
  • History of renal insufficiency as TXA is renally excreted
  • Acquired colour vision defects as one of the first signs of long term TXA toxicity is colour vision disturbance.

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low Dose

High Dose

Placebo

Arm Description

TXA 10mg/kg bolus before incision and 5 mg/kg infusion until skin closure

TXA 100 mg/kg bolus before incision and 10 mg/kg infusion until skin closure

Normal saline 10 ml before skin incision and infusion according to weight until skin closure

Outcomes

Primary Outcome Measures

Blood Loss
Blood loss will be carefully measured in sponges, suction cannisters, cell saver systems, and in the plastic pockets of surgical drapes.

Secondary Outcome Measures

Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples
PAI-1 promotes clot stability and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery
Thromboelastography (TEG)Sample
TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis)

Full Information

First Posted
March 23, 2010
Last Updated
July 11, 2019
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01094977
Brief Title
Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid
Official Title
Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid Undergoing Craniosynostosis Reconstruction: A Randomized Placebo-Controlled Double Blind Study of Low and High Dose Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Suspended
Why Stopped
Inadequate funding
Study Start Date
January 2010 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis surgery.
Detailed Description
Blood loss during pediatric craniosynostosis surgery can be significant and this may be exacerbated by a dilutional coagulopathy. Multimodal blood conservation strategies may limit allogeneic transfusions, although RCTs are few and limited. It is essential to investigate these techniques to determine their potential to reduce allogeneic blood transfusions and their associated cost and morbidity. Tranexamic acid (TXA) is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator. The result is inhibition of fibrinolysis and clot degradation. Recent studies in adults undergoing cardiac surgery demonstrated that people with different genotypes for the plasminogen activator inhibitor-1 (PAI-1) gene may have varying degrees of bleeding. PAI-1 inhibits the transformation of plasminogen to plasmin thereby decreasing plasmin-induced fibrinolysis. Thus, PAI-1 promotes clot stability and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniosynostoses
Keywords
Blood Loss and Transfusion, Craniosynostoses, Tranexamic Acid, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm Description
TXA 10mg/kg bolus before incision and 5 mg/kg infusion until skin closure
Arm Title
High Dose
Arm Type
Experimental
Arm Description
TXA 100 mg/kg bolus before incision and 10 mg/kg infusion until skin closure
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline 10 ml before skin incision and infusion according to weight until skin closure
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
10 mg/kg bolus with a 5 mg/kg/h infusion
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
100 mg/kg bolus with a 10 mg/kg/h infusion
Intervention Type
Drug
Intervention Name(s)
Saline Placebo
Primary Outcome Measure Information:
Title
Blood Loss
Description
Blood loss will be carefully measured in sponges, suction cannisters, cell saver systems, and in the plastic pockets of surgical drapes.
Time Frame
Prior and Post Surgery
Secondary Outcome Measure Information:
Title
Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples
Description
PAI-1 promotes clot stability and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery
Time Frame
Sample will be drawn immediately after induction and prior to administration of study drug
Title
Thromboelastography (TEG)Sample
Description
TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis)
Time Frame
Baseline, immediately after bolus dose of TXA is infused

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants aged 2 months to 2 years undergoing anterior cranial vault reconstruction Exclusion Criteria: Known bleeding disorder as this may increase the risk of bleeding Current antifibrinolytic therapy as these patients may bleed less Patient or family history of thromboembolic disease as there may be potential risk of thrombosis Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding Known allergy to TXA History of renal insufficiency as TXA is renally excreted Acquired colour vision defects as one of the first signs of long term TXA toxicity is colour vision disturbance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara Der, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

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