NCT01201070

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

September 15, 2010

Status Verified

July 1, 2010

Enrollment Period

2.2 years

First QC Date

September 8, 2010

Last Update Submit

September 14, 2010

Conditions

Aortic Valve InsufficiencyAortic Valve StenosisMitral Valve InsufficiencyMitral Valve StenosisAcute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

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

    until 5 days after surgey

Secondary Outcomes (4)

  • Number of participants with infection as a measure of safety.

    until 5 days after surgery

  • Number of participants with delirium as a measure of safety.

    until 5 days after surgery

  • Number of participants with wound complication as a measure of safety.

    until 5 days after surgery

  • Number of participants with multi organ failure as a measure of safety.

    until 5 days after surgery

Study Arms (3)

control group

NO INTERVENTION

no treatment

NO INTERVENTION

TREATMENT WITH ANTITHROMBIN

ACTIVE COMPARATOR

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

Interventions

antithrombin IIIDRUG

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

TREATMENT WITH ANTITHROMBIN

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria Policlinico

Bari, 70124, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve InsufficiencyAortic Valve StenosisMitral Valve InsufficiencyMitral Valve StenosisAcute Coronary Syndrome

Interventions

Antithrombin III

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionMyocardial IschemiaVascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Domenico Paparella, Investigator

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico Paparella, MD

CONTACT

+39 080 559 5075dpaparella@cardiochir.uniba.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 14, 2010

Study Start

September 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

September 15, 2010

Record last verified: 2010-07

Locations

IT(1)