Aortic Valve InsufficiencyPhase 4ATIIINCT01201070
Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
A Phase 4 study testing antithrombin III in people with Aortic Valve Insufficiency and Aortic Valve Stenosis, run by University of Bari at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency
- What is being tested?
- antithrombin III
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2009to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients were candidates for cardiac surgery intervention in extracorporeal circulation
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico
Bari, 70124
Paparella, MD, dpaparella@cardiochir.uniba.it
Crescenzia Rotunno, BSc
About this study
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
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).
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency, Mitral Valve Stenosis, Acute Coronary Syndrome
- Being tested
- antithrombin III
- Medical subject headings
- Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency, Mitral Valve Stenosis, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| no treatment | No intervention | Not described |
| 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 Receives: Drug: antithrombin III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with reduced bleeding, transfusion requirements and need of reintervention for bleeding as a measure of efficacy.
Measured: until 5 days after surgey
Secondary outcomes (4)
Number of participants with infection as a measure of safety.
Measured: until 5 days after surgery
Number of participants with delirium as a measure of safety.
Measured: until 5 days after surgery
Number of participants with wound complication as a measure of safety.
Measured: until 5 days after surgery
Number of participants with multi organ failure as a measure of safety.
Measured: until 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Investigators
- Domenico Paparella, Investigator, Principal investigator, Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201070
- Sponsor's protocol ID
- Antithrombin III
- Acronym
- ATIII
- Status last verified
- Jul 2010
- First submitted
- 8 Sep 2010
- Last updated
- 15 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01201070
- Acronym / sponsor ID
- ATIII / Antithrombin III
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency, Mitral Valve Stenosis, Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| no treatment | No intervention | – |
| TREATMENT WITH ANTITHROMBIN | Active comparator | Drug: antithrombin III3000 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients were candidates for cardiac surgery intervention in extracorporeal circulation
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antithrombin III3000 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 | TREATMENT WITH ANTITHROMBIN |
Primary outcome
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
4 secondary outcomes
Number of participants with infection as a measure of safety.
Time frame: until 5 days after surgery
Number of participants with delirium as a measure of safety.
Time frame: until 5 days after surgery
Number of participants with wound complication as a measure of safety.
Time frame: until 5 days after surgery
Number of participants with multi organ failure as a measure of safety.
Time frame: until 5 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Domenico Paparella, Investigator principal investigator
Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing antithrombin III in people with Aortic Valve Insufficiency and Aortic Valve Stenosis, run by University of Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Domenico Paparella, MD (+39 080 559 5075, dpaparella@cardiochir.uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2010.