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
  Purpose

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).


Condition Intervention Phase
Aortic Valve Insufficiency
Aortic Valve Stenosis
Mitral Valve Insufficiency
Mitral Valve Stenosis
Acute Coronary Syndrome
Drug: antithrombin III
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University of Bari:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: September 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201070

Contacts
Contact: Domenico Paparella, MD +39 080 559 5075 dpaparella@cardiochir.uniba.it

Locations
Italy
Azienda Ospedaliero-Universitaria Policlinico Recruiting
Bari, Italy, 70124
Contact: Paparella, MD       dpaparella@cardiochir.uniba.it   
Sub-Investigator: Crescenzia Rotunno, BSc         
Sponsors and Collaborators
University of Bari
Investigators
Principal Investigator: Domenico Paparella, Investigator Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy
  More Information

No publications provided

Responsible Party: Department of Emergency and Organ Transplant, Division of Cardiac Surgery, University of Bari, Italy
ClinicalTrials.gov Identifier: NCT01201070     History of Changes
Other Study ID Numbers: Antithrombin III
Study First Received: September 8, 2010
Last Updated: September 14, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Acute Coronary Syndrome
Aortic Valve Insufficiency
Aortic Valve Stenosis
Constriction, Pathologic
Mitral Valve Insufficiency
Mitral Valve Stenosis
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Heart Valve Diseases
Myocardial Ischemia
Pain
Pathological Conditions, Anatomical
Signs and Symptoms
Vascular Diseases
Ventricular Outflow Obstruction
Antithrombin III
Antithrombin Proteins
Antithrombins
Anticoagulants
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014