Extracorporeal Circulation; ComplicationsPhase 4NCT03752437
Comparison of Two Dosages of Heparin Before Extracorporeal Circulation
A Phase 4 study testing ACT (Activated Clotting Time) and Heparin in people with Extracorporeal Circulation; Complications, run by Astes at 1 site in Belgium.
Trial summary
In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Circulation; Complications
- What is being tested?
- ACT (Activated Clotting Time) and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2019to 30 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted for cardiac open chest surgery
Who cannot join
- Patient's refusal
- Antithrombin III factor < 75%
- Patient under treatment by heparin IV
Trial locations and contacts
1 site in 1 country.
About this study
In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery.
Read the detailed description
In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery. The first dosage will be 300 IU per kilogram of REAL weight, the second dosage will be 300 IU per kilogram of IDEAL weight.
- Being tested
- ACT (Activated Clotting Time), Heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT (Activated Clotting Time)Diagnostic test
Measure of ACT in the two arms in order to determine if injection of heparin based on ideal weight is better or not than those one on real weight.
HeparinDrug
300 IU of heparin
| Study group | Role | What they receive |
|---|---|---|
| Real Weight | Experimental | Injection of 300 IU of heparin based on REAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection. Receives: Diagnostic Test: ACT (Activated Clotting Time); Drug: Heparin |
| Ideal Weight | Experimental | Injection of 300 IU of heparin based on IDEAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection. Receives: Diagnostic Test: ACT (Activated Clotting Time); Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACT performance
Measure of ACT to be > 400 seconds to allow extracorporeal circulation, but also < 700 seconds to avoid excessive bleeding.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start1 Oct 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Circulation; ComplicationsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One arm will receive 300 IU of heparin based on real weight, and the other arm will receive 300 IU of heparin based on ideal weight.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric DEFLANDRE, MD, PhD, FCCP, FAHA, Astes
- Investigators
- Eric Deflandre, MD, PhD, Principal investigator, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752437
- Sponsor's protocol ID
- MDKR
- Status last verified
- Feb 2022
- First submitted
- 21 Nov 2018
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Dosages of Heparin Before Extracorporeal Circulation
- ClinicalTrials.gov ID
- NCT03752437
- Acronym / sponsor ID
- MDKR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 26 Nov 2018 (actual)
- 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.
In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery.
Detailed description
In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery. The first dosage will be 300 IU per kilogram of REAL weight, the second dosage will be 300 IU per kilogram of IDEAL weight.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- One arm will receive 300 IU of heparin based on real weight, and the other arm will receive 300 IU of heparin based on ideal weight.
| Arm | Type | Receives |
|---|---|---|
| Real Weight | Experimental | Diagnostic Test: ACT (Activated Clotting Time), Drug: HeparinInjection of 300 IU of heparin based on REAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection. |
| Ideal Weight | Experimental | Diagnostic Test: ACT (Activated Clotting Time), Drug: HeparinInjection of 300 IU of heparin based on IDEAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted for cardiac open chest surgery
Key exclusion criteria (3 listed)
- Patient's refusal
- Antithrombin III factor < 75%
- Patient under treatment by heparin IV
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 |
|---|---|---|
| ACT (Activated Clotting Time)Measure of ACT in the two arms in order to determine if injection of heparin based on ideal weight is better or not than those one on real weight. | Diagnostic test | Ideal Weight, Real Weight |
| Heparin300 IU of heparin | Drug | Ideal Weight, Real Weight |
Primary outcome
ACT performance
Time frame: 1 minute
Measure of ACT to be > 400 seconds to allow extracorporeal circulation, but also < 700 seconds to avoid excessive bleeding.
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 15 Feb 2022.
Related trials for Extracorporeal Circulation; Complications
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Active, not recruitingObservational study
Effect of Minimally Invasive Extracorporeal Circulation on Optic Nerve Sheath Diameter and Stroke Incidence in Isolated Open Heart Surgery
Stroke, Cardiac Surgery
Recruiting
MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
Coronary Artery Disease, Aortic Valve Stenosis
Recruiting
Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.
Acute Kidney Injury, ARDS
Active, not recruitingPhase 3
Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation
Scheduled Cardiac Surgery With Extracorporeal Circulation, Vasoplegic Syndrome
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.
Eric Deflandre, MD, PhD principal investigator
Astes
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 ACT (Activated Clotting Time) and Heparin in people with Extracorporeal Circulation; Complications, run by Astes at 1 site in Belgium.
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 3 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 15 Feb 2022. 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 Belgium. 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?
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?
ACT performance (time frame: 1 minute). 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 Feb 2022.