Back to resultsTranexamic Acid in Cyanotic Heart Defects
Primary Purpose
Postoperative Hemorrhage
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Normal saline at induction
Normal saline infusion
Intravenous tranexamic acid
infusion tranexamic acid
topical tranexamic acid
topical normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Hemorrhage focused on measuring Pediatric, Cyanotic heart disease, Tranexamic acid, Postoperative blood loss
Eligibility Criteria
Inclusion Criteria:
2 to 12 years cyanotic cardiac disease with cardio pulmonary bypass
Exclusion Criteria:
Previous cardiac surgery any operation within 48 hr., previous inotropes or mechanical vention aprotinin exposure Liver or renal impairment Coagulation or hemostatic dysfunction within the last 7 days before surgery.
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
In control group will receive normal saline,
Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours
the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.
Outcomes
Primary Outcome Measures
postoperative blood loss
Blood loss will be measured within first 24 hr.
Secondary Outcome Measures
total blood transfusion
ml/kg
the interval from protamine to skin closure
the interval from protamine to skin closure
the length of ICU stay
by days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03244423
Brief Title
Tranexamic Acid in Cyanotic Heart Defects
Official Title
Tranexamic Acid in Cyanotic Heart Defects: a Risk-benefit Analysis.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery has been described in many studies
Detailed Description
40 patients in each one of the three groups; In control group will receive normal saline, Intravenous Tranexamic acid group received 50 mg / kg intravenousely followed by of 1 mg/kg/hr.for six hours. The topical Tranexamic acid group will have 50 mg / kg of tranexamic poured into the pericoredial cavity. in the first 24 hours we will measure the total blood loss and transfusion requirements. Complate blood picture and coagulation studies will be recorded. the occurrence of re-exploration for excess bleeding, or adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hemorrhage
Keywords
Pediatric, Cyanotic heart disease, Tranexamic acid, Postoperative blood loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
In control group will receive normal saline,
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.
Intervention Type
Drug
Intervention Name(s)
Normal saline at induction
Intervention Description
0.5 ml/kg
Intervention Type
Drug
Intervention Name(s)
Normal saline infusion
Intervention Description
1ml/kg/hr. during surgery for six hours
Intervention Type
Drug
Intervention Name(s)
Intravenous tranexamic acid
Intervention Description
50 mg/kg
Intervention Type
Drug
Intervention Name(s)
infusion tranexamic acid
Intervention Description
1mg/kg/hr infusionfor 6 hours
Intervention Type
Drug
Intervention Name(s)
topical tranexamic acid
Intervention Description
50 mg/kg added to the normal saline 2 ml/kg into the pericardial cavity before sternal closure
Intervention Type
Drug
Intervention Name(s)
topical normal saline
Intervention Description
2 ml/kg into the pericardial cavity before sternal closure
Primary Outcome Measure Information:
Title
postoperative blood loss
Description
Blood loss will be measured within first 24 hr.
Time Frame
within the first 24 hours
Secondary Outcome Measure Information:
Title
total blood transfusion
Description
ml/kg
Time Frame
within the first 24 hours
Title
the interval from protamine to skin closure
Description
the interval from protamine to skin closure
Time Frame
within the first 24 hours
Title
the length of ICU stay
Description
by days
Time Frame
within the first month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
2 to 12 years cyanotic cardiac disease with cardio pulmonary bypass
Exclusion Criteria:
Previous cardiac surgery any operation within 48 hr., previous inotropes or mechanical vention aprotinin exposure Liver or renal impairment Coagulation or hemostatic dysfunction within the last 7 days before surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayed k Abd-Elshafy, MD
Organizational Affiliation
Associate profossor of anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
ZIP/Postal Code
74111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
UNDECIDED
Learn more about this trial
Tranexamic Acid in Cyanotic Heart Defects
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