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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2010 by University of Bari.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University of Bari

ClinicalTrials.gov Identifier:

NCT01201070

First received: September 8, 2010

Last updated: September 14, 2010

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2010

Last Updated Date

September 14, 2010

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Number of participants with reduced bleeding (chest tube output), transfusion requirements and need of reintervention for bleeding as a measure of efficacy. [ Time Frame: until 5 days after surgey ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01201070 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of participants with infection as a measure of safety. [ Time Frame: until 5 days after surgery ] [ Designated as safety issue: Yes ]
Number of participants with delirium as a measure of safety. [ Time Frame: until 5 days after surgery ] [ Designated as safety issue: Yes ]
Number of participants with wound complication as a measure of safety. [ Time Frame: until 5 days after surgery ] [ Designated as safety issue: Yes ]
Number of participants with multi organ failure as a measure of safety. [ Time Frame: until 5 days after surgery ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Number of participants with infection, delirium, wound complication or multi organ failure as a measure of safety. [ Time Frame: until 5 days after surgery ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care

Condition ^ICMJE

Aortic Valve Insufficiency
Aortic Valve Stenosis
Mitral Valve Insufficiency
Mitral Valve Stenosis
Acute Coronary Syndrome

Intervention ^ICMJE

Drug: antithrombin III

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

Study Arm (s)

No Intervention: control group
No Intervention: no treatment
Active Comparator: TREATMENT WITH ANTITHROMBIN
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: Drug: antithrombin III

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2011

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Domenico Paparella, MD

+39 080 559 5075

dpaparella@cardiochir.uniba.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01201070

Other Study ID Numbers ^ICMJE

Antithrombin III

Has Data Monitoring Committee

Yes

Responsible Party

Department of Emergency and Organ Transplant, Division of Cardiac Surgery, University of Bari, Italy

Study Sponsor ^ICMJE

University of Bari

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Domenico Paparella, Investigator

Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy

Information Provided By

University of Bari

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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