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Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery (ATIII)

Primary Purpose

Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
antithrombin III
Sponsored by
University of Bari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aortic Valve Insufficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients were candidates for cardiac surgery intervention in extracorporeal circulation

Exclusion Criteria:

  • positive history for allergic reactions to AT III
  • cardiac surgery "Off-Pump"
  • administration of AT during surgery or within 48 h
  • treatment with drugs and non-steroidal steroids within 48 h prior
  • disorders of coagulation
  • platelets <30,000
  • pre-existing IRC in dialysis treatment
  • severe liver failure
  • enlistment in another trial in the last 30 days
  • hypothermia
  • emergency
  • reopening
  • length of CEC> 180 minutes
  • subjects incapable of giving legal consent

Sites / Locations

  • Azienda Ospedaliero-Universitaria PoliclinicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Active Comparator

Arm Label

control group

no treatment

TREATMENT WITH ANTITHROMBIN

Arm Description

3000 IU bolus at the time of randomization vs the study group 1000 IU after 8 h (24 h G0) 1000 IU after 16 h (8 h G1) TOTAL 5000/UI 24h

Outcomes

Primary Outcome Measures

Number of participants with reduced bleeding, transfusion requirements and need of reintervention for bleeding as a measure of efficacy.

Secondary Outcome Measures

Number of participants with infection as a measure of safety.
Number of participants with delirium as a measure of safety.
Number of participants with wound complication as a measure of safety.
Number of participants with multi organ failure as a measure of safety.

Full Information

First Posted
September 8, 2010
Last Updated
September 14, 2010
Sponsor
University of Bari
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1. Study Identification

Unique Protocol Identification Number
NCT01201070
Brief Title
Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
Acronym
ATIII
Official Title
Effects of the Administration Of Antithrombin on the Coagulation Status and on the Inflammatory Response in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bari

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
General and specific objectives of the search: evaluate the effects of the administration of Antithrombin III (ATIII) on the activation of the coagulation system and of the fibrinolysis, platelet function, inflammatory response and markers of organ damage in patients undergoing cardiac surgery by cardiopulmonary bypass (CPB) with low plasma levels of post-operative Antithrombin (AT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency, Mitral Valve Stenosis, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Title
no treatment
Arm Type
No Intervention
Arm Title
TREATMENT WITH ANTITHROMBIN
Arm Type
Active Comparator
Arm Description
3000 IU bolus at the time of randomization vs the study group 1000 IU after 8 h (24 h G0) 1000 IU after 16 h (8 h G1) TOTAL 5000/UI 24h
Intervention Type
Drug
Intervention Name(s)
antithrombin III
Intervention Description
3000 IU bolus at the time of randomization vs the study group 1000 IU after 8 h (24 h G0) 1000 IU after 16 h (8 h G1) TOTAL 5000/UI 24h
Primary Outcome Measure Information:
Title
Number of participants with reduced bleeding, transfusion requirements and need of reintervention for bleeding as a measure of efficacy.
Time Frame
until 5 days after surgey
Secondary Outcome Measure Information:
Title
Number of participants with infection as a measure of safety.
Time Frame
until 5 days after surgery
Title
Number of participants with delirium as a measure of safety.
Time Frame
until 5 days after surgery
Title
Number of participants with wound complication as a measure of safety.
Time Frame
until 5 days after surgery
Title
Number of participants with multi organ failure as a measure of safety.
Time Frame
until 5 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients were candidates for cardiac surgery intervention in extracorporeal circulation Exclusion Criteria: positive history for allergic reactions to AT III cardiac surgery "Off-Pump" administration of AT during surgery or within 48 h treatment with drugs and non-steroidal steroids within 48 h prior disorders of coagulation platelets <30,000 pre-existing IRC in dialysis treatment severe liver failure enlistment in another trial in the last 30 days hypothermia emergency reopening length of CEC> 180 minutes subjects incapable of giving legal consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Domenico Paparella, MD
Phone
+39 080 559 5075
Email
dpaparella@cardiochir.uniba.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domenico Paparella, Investigator
Organizational Affiliation
Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria Policlinico
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paparella, MD
Email
dpaparella@cardiochir.uniba.it
First Name & Middle Initial & Last Name & Degree
Crescenzia Rotunno, BSc

12. IPD Sharing Statement

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Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery

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