Acquired Antithrombin III DeficiencyPhase 2NCT00823082
Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
A Phase 2 study testing Antithrombin III in people with Acquired Antithrombin III Deficiency and Coronary Artery Bypass, run by Instituto Grifols, S.A. at 1 site in Italy.
Trial summary
The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Antithrombin III Deficiency, Coronary Artery Bypass
- What is being tested?
- Antithrombin III
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2009to Sep 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- At least 18 years of age
- Subject needed elective cardiac surgery with cardiopulmonary bypass except for heart transplantation
- Subject had a baseline ATIII level of less than 100% and equal to or above 60%
- Subject signed the informed consent form
- Subject was willing to comply with all aspects of the protocol, including blood sampling, for the total duration of the study
Who cannot join
- Documented congenital ATIII deficiency or ATIII levels below 60%
- Subject had a baseline ATIII level of 100% or higher
- Subject needed emergency (non-elective) surgery
- Subject needed heart transplantation
- History of anaphylactic reaction(s) to blood or blood components
- Allergies to excipients
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- Subject was pregnant
- Subject had any medical condition that according to the investigators judgment worsens the surgical outcome above the expected
- Subject had any medical condition which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the trial according to the investigators judgment
- Subject had participated in any another investigational study within the last 30 days previous to the inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Pilot Study to Evaluate the Effect of Preoperative Antithrombin Supplementation on Postoperative Levels of Antithrombin in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.
- Being tested
- Antithrombin III
- Keywords
- antithrombin, ATIII, acquired deficiency, anticoagulants, cardiopulmonary bypass, surgery, complications, postoperative outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombin IIIDrug
Also called Anbinex, ATIII
Single dose of antithrombin III sufficient to achieve a preoperative level of 120%
| Study group | Role | What they receive |
|---|---|---|
| Antithrombin III treatment group | Experimental | Preoperative ATIII supplementation administered immediately after anesthesia induction Receives: Drug: Antithrombin III |
| Control group | No intervention | No preoperative ATIII supplementation administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative ATIII Levels at the ICU Admission
Measurement of postoperative ATIII functional activity at ICU admission
Measured: ICU admission
Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission
Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission
Measured: ICU admission
Secondary outcomes (13)
Percentage of Subjects With Postoperative Myocardial Infarction
Percentage of subjects with postoperative myocardial infarction defined through enzymatic criteria plus new Q-waves at the electrocardiogram
Measured: During ICU stay (maximum 70 days)
Percentage of Subjects With Adverse Neurologic Outcome
Percentage of subjects with adverse neurologic outcome defined as: coma, stroke or psychotic behaviors lasting >12 hours after extubation
Measured: During ICU stay (maximum 70 days)
Percentage of Patients With Thromboembolic Events
Percentage of subjects with thromboembolic events defined as perioperative myocardial infarction, stroke, mesenteric infarction, peripheral thromboembolism and pulmonary embolism
Measured: During ICU stay (maximum 70 days)
ICU Stay Duration
Measured: During ICU stay (maximum 70 days)
In-hospital Postoperative Mortality
Measured: 70 days after ICU admission (maximum)
Heparin Resistance
Percentage of subjects with heparin resistance defined as failure to reach an activated clotting time >450 seconds after a dose of up to 400 IU/kg of heparin, or failure to maintain this activated clotting time value despite heparin supplementations of 100 IU/kg per each dose with an interval of at least 30 minutes between doses
Measured: Immediately after anesthesia induction
Postoperative Blood Loss in First 12 Hours
Blood loss defined as the amount of blood collected in the cardiotomy reservoir from ICU admission through the following 12 hours
Measured: ICU admission through 12 hours post-operative
Need for Blood Products
Number of units of packed red blood cells, fresh frozen plasma, and/or platelets needed
Measured: During ICU stay (maximum 70 days)
Percentage of Subjects Needing Surgical Re-exploration
Percentage of subjects needing surgical re-exploration resulting from bleeding
Measured: During ICU stay (maximum 70 days)
Percentage of Subjects With Low Cardiac Syndrome
Percentage of subjects with low cardiac syndrome defined as the need for major inotropic support or intra-aortic balloon pump
Measured: During ICU stay (maximum 70 days)
Percentage of Subjects With Renal Dysfunction
Percentage of subjects with renal dysfunction defined as an increase of serum creatinine levels to >2.0 and twice the baseline level or need for renal replacement therapy
Measured: During ICU stay (maximum 70 days)
Mechanical Ventilation Duration
Measured: During ICU stay (maximum 70 days)
Length of Hospital Stay
Length of hospital stay (days) in both groups was defined as the discharge date minus the surgery date plus 1 day, during a maximum of 70 days after ICU admission.
Measured: During ICU stay (maximum 70 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Antithrombin III DeficiencyStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Ranucci, MD, Principal investigator, IRCCS Policlinico San Donato, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823082
- Sponsor's protocol ID
- IG0801
- Status last verified
- Aug 2016
- First submitted
- 14 Jan 2009
- Last updated
- 20 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ranucci M, Baryshnikova E, Crapelli GB, Woodward MK, Paez A, Pelissero G. Preoperative antithrombin supplementation in cardiac surgery: a randomized controlled trial. J Thorac Cardiovasc Surg. 2013 May;145(5):1393-9. doi: 10.1016/j.jtcvs.2012.09.061. Epub 2012 Oct 25.
PubMed 23102903
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Pilot Study to Evaluate the Effect of Preoperative Antithrombin Supplementation on Postoperative Levels of Antithrombin in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00823082
- Acronym / sponsor ID
- IG0801
- Keywords
- antithrombin, ATIII, acquired deficiency, anticoagulants, cardiopulmonary bypass, surgery, complications, postoperative outcomes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Posted 4 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antithrombin III treatment group | Experimental | Drug: Antithrombin IIIPreoperative ATIII supplementation administered immediately after anesthesia induction |
| Control group | No intervention | –No preoperative ATIII supplementation administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- At least 18 years of age
- Subject needed elective cardiac surgery with cardiopulmonary bypass except for heart transplantation
- Subject had a baseline ATIII level of less than 100% and equal to or above 60%
- Subject signed the informed consent form
Key exclusion criteria (10 listed)
- Documented congenital ATIII deficiency or ATIII levels below 60%
- Subject had a baseline ATIII level of 100% or higher
- Subject needed emergency (non-elective) surgery
- Subject needed heart transplantation
- History of anaphylactic reaction(s) to blood or blood components
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 IIIAlso: Anbinex, ATIIISingle dose of antithrombin III sufficient to achieve a preoperative level of 120% | Drug | Antithrombin III treatment group |
Primary outcome
Postoperative ATIII Levels at the ICU Admission
Time frame: ICU admission
Measurement of postoperative ATIII functional activity at ICU admission
Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission
Time frame: ICU admission
Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission
13 secondary outcomes
Percentage of Subjects With Postoperative Myocardial Infarction
Time frame: During ICU stay (maximum 70 days)
Percentage of Subjects With Adverse Neurologic Outcome
Time frame: During ICU stay (maximum 70 days)
Percentage of Patients With Thromboembolic Events
Time frame: During ICU stay (maximum 70 days)
ICU Stay Duration
Time frame: During ICU stay (maximum 70 days)
In-hospital Postoperative Mortality
Time frame: 70 days after ICU admission (maximum)
Heparin Resistance
Time frame: Immediately after anesthesia induction
Postoperative Blood Loss in First 12 Hours
Time frame: ICU admission through 12 hours post-operative
Need for Blood Products
Time frame: During ICU stay (maximum 70 days)
Percentage of Subjects Needing Surgical Re-exploration
Time frame: During ICU stay (maximum 70 days)
Percentage of Subjects With Low Cardiac Syndrome
Time frame: During ICU stay (maximum 70 days)
Percentage of Subjects With Renal Dysfunction
Time frame: During ICU stay (maximum 70 days)
Mechanical Ventilation Duration
Time frame: During ICU stay (maximum 70 days)
Length of Hospital Stay
Time frame: During ICU stay (maximum 70 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23102903Ranucci M, Baryshnikova E, Crapelli GB, Woodward MK, Paez A, Pelissero G. Preoperative antithrombin supplementation in cardiac surgery: a randomized controlled trial. J Thorac Cardiovasc Surg. 2013 May;145(5):1393-9. doi: 10.1016/j.jtcvs.2012.09.061. Epub 2012 Oct 25.
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Acquired Antithrombin Deficiency
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.
Marco Ranucci, MD principal investigator
IRCCS Policlinico San Donato, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antithrombin III in people with Acquired Antithrombin III Deficiency and Coronary Artery Bypass, run by Instituto Grifols, S.A. 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 20 Sep 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative ATIII Levels at the ICU Admission (time frame: ICU admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00823082, which also lists 1 linked publication.
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 20 Sep 2016.