NCT00823082

Brief Summary

The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

August 4, 2016

Completed
Last Updated

September 20, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

January 14, 2009

Results QC Date

April 5, 2016

Last Update Submit

August 10, 2016

Conditions

Acquired Antithrombin III DeficiencyCoronary Artery Bypass

Keywords

antithrombinATIIIacquired deficiencyanticoagulantscardiopulmonary bypasssurgerycomplicationspostoperative outcomes

Outcome Measures

Primary Outcomes (2)

  • Postoperative ATIII Levels at the ICU Admission

    Measurement of postoperative ATIII functional activity at ICU admission

    ICU admission

  • Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission

    Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission

    ICU admission

Secondary Outcomes (13)

  • Percentage of Subjects With Postoperative Myocardial Infarction

    During ICU stay (maximum 70 days)

  • Percentage of Subjects With Adverse Neurologic Outcome

    During ICU stay (maximum 70 days)

  • Percentage of Patients With Thromboembolic Events

    During ICU stay (maximum 70 days)

  • ICU Stay Duration

    During ICU stay (maximum 70 days)

  • In-hospital Postoperative Mortality

    70 days after ICU admission (maximum)

  • +8 more secondary outcomes

Study Arms (2)

Antithrombin III treatment group

EXPERIMENTAL

Preoperative ATIII supplementation administered immediately after anesthesia induction

Drug: Antithrombin III

Control group

NO INTERVENTION

No preoperative ATIII supplementation administered

Interventions

Antithrombin IIIDRUG

Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

Also known as: Anbinex, ATIII
Antithrombin III treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • At least 18 years of age
  • Subject needed elective cardiac surgery with cardiopulmonary bypass except for heart transplantation
  • Subject had a baseline ATIII level of less than 100% and equal to or above 60%
  • Subject signed the informed consent form
  • Subject was willing to comply with all aspects of the protocol, including blood sampling, for the total duration of the study

You may not qualify if:

  • Documented congenital ATIII deficiency or ATIII levels below 60%
  • Subject had a baseline ATIII level of 100% or higher
  • Subject needed emergency (non-elective) surgery
  • Subject needed heart transplantation
  • History of anaphylactic reaction(s) to blood or blood components
  • Allergies to excipients
  • Subject was pregnant
  • Subject had any medical condition that according to the investigators judgment worsens the surgical outcome above the expected
  • Subject had any medical condition which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the trial according to the investigators judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Donato

Milan, Lombardy, 20097, Italy

Location

Related Publications (1)

  • Ranucci M, Baryshnikova E, Crapelli GB, Woodward MK, Paez A, Pelissero G. Preoperative antithrombin supplementation in cardiac surgery: a randomized controlled trial. J Thorac Cardiovasc Surg. 2013 May;145(5):1393-9. doi: 10.1016/j.jtcvs.2012.09.061. Epub 2012 Oct 25.

    PMID: 23102903DERIVED

MeSH Terms

Interventions

Antithrombin III

Intervention Hierarchy (Ancestors)

Antithrombin ProteinsSerpinsPeptidesAmino Acids, Peptides, and ProteinsAlpha-GlobulinsSerum GlobulinsBlood ProteinsProteinsGlobulinsBlood Coagulation Factor InhibitorsBiological Factors

Results Point of Contact

Title
Michael Ken Woodward, BSc, M.Sc
Organization
GrifolsTherapeutics Inc.
michael.woodward@grifols.com
+1 919-316-6675

Study Officials

  • Marco Ranucci, MD

    IRCCS Policlinico San Donato, Milano

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2009

First Posted

January 15, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

September 1, 2011

Last Updated

September 20, 2016

Results First Posted

August 4, 2016

Record last verified: 2016-08

Locations

IT(1)