Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery

NCT02103114 | Completed Phase 2 Results

• 1 other identifier: Pro00051186
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

ATIII Deficiency

Outcome Measures

Primary Outcomes (1)

• 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)

  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).

  Time 5 (on arrival in ICU)

Secondary Outcomes (24)

• 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

• 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)

• 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

• Residual Heparin at the ICU Arrival Time Point Represented by a Decreased Anti Factor Xa Level.

  T5 (Intensive Care Unit Arrival)

Study Arms (2)

Anti-thrombin III

EXPERIMENTAL

Drug: Anti-thrombin III

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Anti-thrombin III DRUG

Intraoperatively- (correcting to 100%) according to the following formula: Units required = ((100%- baseline ATIII level\*%) X body weight)/1.4 * expressed as a % normal level based on functional ATIII assay

Also known as: Thrombate III

Anti-thrombin III

Placebo OTHER

Normal saline placebo

Placebo

Eligibility Criteria

• Age: Up to 7 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Grifols Biologicals, LLC: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Interventions

Antithrombin III

Intervention Hierarchy (Ancestors)

Antithrombin Proteins; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Alpha-Globulins; Serum Globulins; Blood Proteins; Proteins; Globulins; Blood Coagulation Factor Inhibitors; Biological Factors

Results Point of Contact

• Title: Dr. Edmund Jooste
• Organization: Duke University

edmund.jooste@duke.edu

919-681-4877

Study Officials

• Edmund Jooste, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 3, 2014
• Study Start: June 1, 2014
• Primary Completion: June 27, 2016
• Study Completion: July 1, 2016
• Last Updated: November 25, 2019
• Results First Posted: July 26, 2017

Record last verified: 2019-11

Locations

US (1)