Antithrombin III in Infants With Cardiopulmonary Bypass (CPB)

NCT01698567 | Terminated Phase 1 DMC

• 1 other identifier: 38402
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to discern whether supplementation of Antithrombin III will decrease coagulation and inflammation associated with cardiopulmonary bypass in infants undergoing cardiac surgery.

Conditions

Congenital Heart Disease

Keywords

Infants; Cardiopulmonary bypass; anticoaglution

Outcome Measures

Primary Outcomes (1)

• The primary hypothesis is that treatment with ATIII before bypass will decrease the activation of inflammation during CPB as measured by plasma neutrophil elastase.

  Patients treated with ATIII as standard of care (good clinical practice) will remain in the study and be analyzed by their intention to treat group. Review of our clinical experience shows that treatment with ATIII for heparin resistance occurs in 2-3% of cases. If there are more than two patients so treated, we will also perform an "as-treated" analysis.

  Expected average of 24 months

Secondary Outcomes (6)

• p-selectin

  expected average of 24 months

• interleukin-6

  Expected average of 24 months

• prothrombin fragment 1.2

  expected average of 24 months

• 24 hour blood loss

  24 hours post surgery

• ICU length of stay

  Expected average of 3 days

Study Arms (2)

Antithrombin III

ACTIVE COMPARATOR

Product- Antithrombin III is derived from pooled human plasma ATIII will be dosed using the formula recommended by the manufacturer: (goal activity - baseline activity) x weight (kg) x .714 (Assume: start with 35% activity \[7\], goal 120% activity\[18\], so dose = 120-35 x wt (kg) x .714, e.g. 5 kg infant: 85 x 5 x .714 = 303 units) a.

Drug: Placebo

Placebo

PLACEBO COMPARATOR

placebo (normal saline)

Drug: Antithrombin III

Interventions

Antithrombin III DRUG

ATIII will be dosed using the formula recommended by the manufacturer: (goal activity - baseline activity) x weight (kg) x .714 (Assume: start with 35% activity \[7\], goal 120% activity\[18\], so dose = 120-35 x wt (kg) x .714, e.g. 5 kg infant: 85 x 5 x .714 = 303 units)

Also known as: Thrombate

Placebo

Placebo DRUG

placebo (normal saline) after induction of anesthesia and before commencement of bypass. ATIII will be dosed using the formula recommended by the manufacturer: (goal activity - baseline activity) x weight (kg) x .714 (Assume: start with 35% activity \[7\], goal 120% activity\[18\], so dose = 120-35 x wt (kg) x .714, e.g. 5 kg infant: 85 x 5 x .714 = 303 units)

Also known as: Normal Saline

Antithrombin III

Eligibility Criteria

• Age: 1 Day - 180 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects will be included if they are presenting for elective cardiac surgery using cardiopulmonary bypass and are 180 days of age or less.

You may not qualify if:

• Sensitivity to ATIII product (Thrombate, Grifols, Los Angeles, CA)
• Known inherited or acquired coagulation defect
• Current or prior treatment with pro-or anticoagulant medication within past 30 days (except aspirin or a single dose of heparin, e.g. for catheterization)
• Known central venous thrombosis
• Recent (30 days) transfusion with hemostatic blood products (fresh-frozen plasma, platelets, cryoprecipitate, whole blood)
• wt less than 3000g

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Michael Eaton, MD

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Antithrombin III; Saline Solution

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Michael Eaton, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: October 3, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

US (1)