NCT02103114CompletedPhase 2
Double Blind Randomized Placebo-controlled Study in Children (<6mo) Comparing the Effects of Anti-thrombin III (ATIII) or Placebo on the Coagulation System in Infants With Known Low ATIII Levels Undergoing Open Congenital Cardiac Surgery
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Difference in the Mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Time 5 (on Arrival in ICU)
Study Overview
Brief Summary
The purpose of this study is to test whether the administration of ATIII during the intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB) and an attenuation of the activation of the coagulation cascade, as represented by a decrease in fibrin degradation products. The investigators believe this benefit would extend into the post-operative period resulting in a decreased incidence of thrombosis generation, as represented by a decrease in fibrin degradation products in the ICU period.
Detailed Description
If Preoperative ATIII functional assay level is less than 70% patients would be enrolled and randomized to either Placebo (normal saline) or ATIII.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 7 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients less than 7 months of age going for cardiac surgery that will require cardiopulmonary bypass (CPB) with a documented ATIII level below 70%
Exclusion Criteria
- •Less than 2.5kg
- •Known or suspected hereditary ATIII deficiency (family history of venous thrombosis with decreased plasma levels of ATIII and no other potential causes of acquired decreased ATIII)
- •On Ecmo (extracorporeal membrane oxygenation ) at time of surgery
- •Known history of thrombosis
- •Renal failure as described by the pediatric RIFLE criteria
- •H/o intracranial hemorrhage
- •Prematurity less than 37 weeks estimated gestational age
- •Previously diagnosed pro-thrombotic or hemorrhagic disorder
- •Prior ATIII supplementation
- •Prior therapeutic anticoagulant use
Arms & Interventions
Anti-thrombin III
Experimental
Intervention: Anti-thrombin III (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Difference in the Mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Time 5 (on Arrival in ICU)
Time Frame: Time 5 (on arrival in ICU)
Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at Time 5 (on arrival in ICU).
Secondary Outcomes
- Difference in the Mean and SD of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Times 5-Time 7 (ICU Arrival to Post Operative Day 4)(ICU arrival (Time 5) to Time 7 (Post-operative Day 4))
- Difference in the Mean the ATIII (Functional Assay) of the Control and ATIII Groups at T1, T2, T3, T5, T6 and T7(T1, T2, T3, T5, T6 and T7)
- Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively(Baseline (Intraoperatively))
- Volume of Postoperative Blood Loss(From 10min post protamine administration to 24 hour post protamine administration)
- Difference in the Median of the ATIII (Functional Assay) of the Control and ATIII Groups at T4(T4 (just prior to coming off of CPB))
- Residual Heparin at the ICU Arrival Time Point Represented by a Decreased Anti Factor Xa Level.(T5 (Intensive Care Unit Arrival))
- Evidence of Decreased Inflammation Represented by a Decrease in Inflammatory Markers in the ATIII Group(Baseline (T1) to Post-Operative Day 4 (T7))
- Difference in the Median of the D Dimer of the Control and ATIII Groups at T1, T5, T6 and T7(T1, T5, T6 and T7)
- Total Dose of Heparin While on Cardiopulmonary Bypass(T1 (Baseline) to T5 (Arrival in ICU))
- Protamine Dose Determined by Hemostasis Management System Machine (mg/kg)(T1 (Baseline) to T5 (Arrival in ICU))
- Total Volume of Blood Products While on CPB(Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4))
- Time From Protamine Administration to Skin Dressing(Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4))
- Total Volume of Fresh Frozen Plasma Given Prior to CPB(Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4))
- Chest Tube Output (Protamine Time Plus 24 Hours) in Milliliters(protamine time plus 24 hours)
- Number of Total Blood Product Units Transfused by Type 24-hours Post-operatively by Group(24 Hours Post-Operatively)
- Number of Total Blood Product Units Transfused 24-hours Post-operatively by Group(24 Hours Post-Operatively)
- Total Dose of Recombinant Factor 7a (VIIa) Used Intraoperatively(Intraoperatively)
- Length of Post Operative Ventilation in Days(ICU arrival (Time 5) to Time 7 (Post-Operative Day 4))
- Incidence of Extracorporeal Membrane Oxygenation (ECMO) Support Within 24 Hours Postoperatively(Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4))
- Incidence of Mediastinal Exploration Within 24 Hours Postoperatively(Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4))
- Incidence (Number) of Thrombotic Events Documented(Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4))
- Incidence of New Onset Renal Failure, Defined by Stage 3 of the AKIN Criteria(Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4))
- Incidence (Number) of Newly Diagnosed Intracranial Hemorrhage(Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4))
- Length of Time to Delayed Sternal Closure Measured in Days(Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4))
Investigators
Study Sites (1)
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