Phase 2
Completed N=40
Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery
ATIII Deficiency
Source: ClinicalTrials.gov NCT02103114 ↗
Enrolled (actual)
40
Serious AEs
27.5%
Results posted
Jul 2017
Primary outcomePrimary: 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)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 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) |
— | — |
| SECONDARY Difference in the Mean the ATIII (Functional Assay) of the Control and ATIII Groups at T1, T2, T3, T5, T6 and T7 |
54; 54; 99; 49; 83; 55 | 0.982 |
| SECONDARY Difference in the Median of the ATIII (Functional Assay) of the Control and ATIII Groups at T4 |
78.0; 69.0 | 0.048 sig |
| SECONDARY Difference in the Median of the D Dimer of the Control and ATIII Groups at T1, T5, T6 and T7 |
1.1; 0.9; 0.6; 1.0; 1.3; 1.7 | 0.855 |
| SECONDARY Residual Heparin at the ICU Arrival Time Point Represented by a Decreased Anti Factor Xa Level. |
0.1; 0.1 | — |
| SECONDARY Evidence of Decreased Inflammation Represented by a Decrease in Inflammatory Markers in the ATIII Group |
— | — |
| SECONDARY Total Dose of Heparin While on Cardiopulmonary Bypass |
3775; 5000 | 0.056 |
| SECONDARY Protamine Dose Determined by Hemostasis Management System Machine (mg/kg) |
9.8; 10.0 | 0.545 |
| SECONDARY Total Volume of Blood Products While on CPB |
57; 101.5; 68.5; 141.9; 89.7; 72.6 | — |
| SECONDARY Time From Protamine Administration to Skin Dressing |
107.0; 89.0 | 0.757 |
| SECONDARY Total Volume of Fresh Frozen Plasma Given Prior to CPB |
15; 5.8 | — |
| SECONDARY Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively |
5; 5 | — |
| SECONDARY Volume of Postoperative Blood Loss |
0.8; 2.8; 0; 2.7; 0; 2.1 | 0.2741 |
| SECONDARY Chest Tube Output (Protamine Time Plus 24 Hours) in Milliliters |
59.0; 113.0 | 0.016 sig |
| SECONDARY Number of Total Blood Product Units Transfused by Type 24-hours Post-operatively by Group |
1; 3; 0; 4; 0; 3 | — |
| SECONDARY Number of Total Blood Product Units Transfused 24-hours Post-operatively by Group |
6; 19 | 0.0004 sig |
| SECONDARY Total Dose of Recombinant Factor 7a (VIIa) Used Intraoperatively |
56.1; 70.6 | 0.927 |
| SECONDARY Length of Post Operative Ventilation in Days |
3.9; 3.6 | 0.738 |
| SECONDARY Incidence of Extracorporeal Membrane Oxygenation (ECMO) Support Within 24 Hours Postoperatively |
0; 2 | 0.231 |
| SECONDARY Incidence of Mediastinal Exploration Within 24 Hours Postoperatively |
2; 3 | 0.661 |
| SECONDARY Incidence (Number) of Thrombotic Events Documented |
0; 0 | — |
| SECONDARY Incidence of New Onset Renal Failure, Defined by Stage 3 of the AKIN Criteria |
1; 1 | 1.0 |
| SECONDARY Incidence (Number) of Newly Diagnosed Intracranial Hemorrhage |
1; 3 | 0.342 |
| SECONDARY Length of Time to Delayed Sternal Closure Measured in Days |
2.7; 2.7 | 0.961 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02103114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.