Cardiopulmonary BypassPhase 3NCT01530737
Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery
A Phase 3 study testing Antithrombin III in people with Cardiopulmonary Bypass, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The primary objective of this study is: 1. To evaluate the use of Antithrombin (AT) concentrate in infants less than one year of age undergoing cardiopulmonary bypass (CPB) for cardiac surgery The secondary objectives of this study are: 1. Read more about this study
- Who is it for?
- Ages Up to 364 days
- Conditions the study is for
- Cardiopulmonary Bypass
- What is being tested?
- Antithrombin III
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Oct 2014
- Phase
- Phase 3
- 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 Up to 364 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients < 1 year old with cardiac defect (acquired or congenital) requiring cardiac surgery
- Planned cardiac surgery with cardiopulmonary bypass
- Weight > 2.5kg at the time of surgery
- Enrolment in the CATCH main study (REB#1000020203)
Who cannot join
- Preoperative antithrombin activity > 85%
- Prematurity < 36 weeks gestational age at birth
- Preoperative use of systemic anticoagulant (i.e. heparin or warfarin at a therapeutic dose) for > 24 hours or at any time within the 48 hours prior to surgery
- Any form of coagulopathy or thrombophilic disorder
- Renal (blood creatinine - estimated GRF < 60ml/min/1.73m2) or clinical liver failure
- Antithrombin replacement therapy prior to surgery
- Repeat surgery (including previous ECMO/VAD support as prior surgery)
- Patients refusal to provide open consent for re-use of study data
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is:
- To evaluate the use of Antithrombin (AT) concentrate in infants less than one year of age undergoing cardiopulmonary bypass (CPB) for cardiac surgery
Read more
The secondary objectives of this study are:
- To determine if the administration of AT concentrate prior to heparinization will decrease the amount of heparin required to achieve optimal anticoagulation (as defined by anti-Xa levels) during CPB
- To determine if a decrease in activation and consumption of coagulation proteins, platelets and subsequent fibrinolysis will result in improved haemostasis following CPB
- To determine if there will be a reduction in postoperative bleeding and associated clinical complications
- Conditions
- Cardiopulmonary Bypass
- Being tested
- Antithrombin III, Saline Placebo
- Keywords
- pediatric, Antithrombin, anticoagulation efficiency, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombin IIIDrug
Patients randomized to receive Antithrombin concentrate will receive a dose of AT to achieve a target value of 1.2U/ml.
Saline PlaceboOther
Patients randomized to the control group will receive a placebo consisting of normal saline in a volume equivalent to the volume of antithrombin the same patient in the treatment group would have received and administered by anesthesia and perfusion in the exact same manner as the AT is administered in the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Not described Receives: Other: Saline Placebo |
| Active Antithrombin Group | Experimental | Not described Receives: Drug: Antithrombin III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest tube volume loss
Chest tube volume loss (mls/kg) at 24 hours in CCCU
Measured: 24 hrs post surgery
Secondary outcomes (6)
Heparin dose required to achieve target Activated Clotting Time required to go on Cardiopulmonary Bypass
Clinical Outcome Measure
Measured: 1hr prior to induction of anaestheisa (pre-surgery)
Blood product transfusions intra-operatively and for the first 24 hours following surgery
Measured: 24hours post surgery
Clinical outcomes
(inotropic support, ventilation, CCU stay, hospital stay, thrombosis)
Measured: 30 days post-surgery
Intraoperative coagulation profile
(anti-Xa, heparin concentration, activated clotting time, CBC, antithrombin)
Measured: 5 hours after start of surgery
Post-operative markers of platelet activation
Post-operative markers of platelet activation (TAT, F1.2), fibrinolysis (d-dimer) and inflammation (CRP)
Measured: 24 and 72 hrs post surgery
Use of recombinant factor VIIa after surgery to control post-operative bleeding
Measured: 48 hrs post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian McCrindle, The Hospital for Sick Children
- Investigators
- Brian W McCrindle, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530737
- Sponsor's protocol ID
- 1000020202
- Status last verified
- Jan 2015
- First submitted
- 30 Jan 2012
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01530737
- Acronym / sponsor ID
- 1000020202
- Conditions
- Cardiopulmonary Bypass
- Keywords
- pediatric, Antithrombin, anticoagulation efficiency, cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Feb 2012 (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.
The primary objective of this study is:
- To evaluate the use of Antithrombin (AT) concentrate in infants less than one year of age undergoing cardiopulmonary bypass (CPB) for cardiac surgery
The secondary objectives of this study are:
- To determine if the administration of AT concentrate prior to heparinization will decrease the amount of heparin required to achieve optimal anticoagulation (as defined by anti-Xa levels) during CPB
- To determine if a decrease in activation and consumption of coagulation proteins, platelets and subsequent fibrinolysis will result in improved haemostasis following CPB
- To determine if there will be a reduction in postoperative bleeding and associated clinical complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Saline Placebo |
| Active Antithrombin Group | Experimental | Drug: Antithrombin III |
Who may qualify
- Ages
- Up to 364 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients < 1 year old with cardiac defect (acquired or congenital) requiring cardiac surgery
- Planned cardiac surgery with cardiopulmonary bypass
- Weight > 2.5kg at the time of surgery
- Enrolment in the CATCH main study (REB#1000020203)
Key exclusion criteria (8 listed)
- Preoperative antithrombin activity > 85%
- Prematurity < 36 weeks gestational age at birth
- Preoperative use of systemic anticoagulant (i.e. heparin or warfarin at a therapeutic dose) for > 24 hours or at any time within the 48 hours prior to surgery
- Any form of coagulopathy or thrombophilic disorder
- Renal (blood creatinine - estimated GRF < 60ml/min/1.73m2) or clinical liver failure
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 IIIPatients randomized to receive Antithrombin concentrate will receive a dose of AT to achieve a target value of 1.2U/ml. | Drug | Active Antithrombin Group |
| Saline PlaceboPatients randomized to the control group will receive a placebo consisting of normal saline in a volume equivalent to the volume of antithrombin the same patient in the treatment group would have received and administered by anesthesia and perfusion in the exact same manner as the AT is administered in the treatment group. | Other | Control Group |
Primary outcome
Chest tube volume loss
Time frame: 24 hrs post surgery
Chest tube volume loss (mls/kg) at 24 hours in CCCU
6 secondary outcomes
Heparin dose required to achieve target Activated Clotting Time required to go on Cardiopulmonary Bypass
Time frame: 1hr prior to induction of anaestheisa (pre-surgery)
Blood product transfusions intra-operatively and for the first 24 hours following surgery
Time frame: 24hours post surgery
Clinical outcomes
Time frame: 30 days post-surgery
Intraoperative coagulation profile
Time frame: 5 hours after start of surgery
Post-operative markers of platelet activation
Time frame: 24 and 72 hrs post surgery
Use of recombinant factor VIIa after surgery to control post-operative bleeding
Time frame: 48 hrs post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2015.
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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.
Brian W McCrindle, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antithrombin III in people with Cardiopulmonary Bypass, run by The Hospital for Sick Children at 1 site in Canada.
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 4 inclusion and 8 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 7 Jan 2015. 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 Canada. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chest tube volume loss (time frame: 24 hrs post surgery). 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 7 Jan 2015.