MedDataX Logo

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

NCT ID: NCT01201070

Last Updated: 2010-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

antithrombin III

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bari

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Bari, Italy

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Domenico Paparella, Investigator

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Azienda Ospedaliero-Universitaria Policlinico

Bari, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Domenico Paparella, MD

Role: CONTACT

[email protected]
+39 080 559 5075

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Paparella, MD

Role: primary

[email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Antithrombin III

Identifier Type: -

Identifier Source: org_study_id