Cardiac SurgeryPhase 4HEPOIRINENCT02675647
Heparin Based on Ideal Body Weight for Cardiopulmonary Bypass in Obese Patients
A Phase 4 study testing Heparin, IV route, based on patients body weights (UI/kg), Cardiopulmonary bypass and Protamin administration in people with Cardiac Surgery and Cardiopulmonary Bypass, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The optimal heparin regimen during cardiopulmonary bypass (CPB) has not been well established in obese patients. Results of a preview study show that the standard heparin management based on total body weight in obese patients during CPB resulted in excessive heparin level, which could lead to excessive postoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Cardiopulmonary Bypass, Obese Patients (BMI ≥ 30 kg/m²)
- What is being tested?
- Heparin, IV route, based on patients body weights (UI/kg), Cardiopulmonary bypass and Protamin administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Dec 2017
- 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
- Obese patients (BMI ≥ 30 kg/m²)
- Planned cardiac surgery under cardiopulmonary bypass
- Coronary-artery bypass graft, or valve surgery)
- Age ≥ 18 yo
Who cannot join
- Allergy to heparin
- Emergency surgical intervention
- Redo surgery
- Heart transplantation
- Surgery for circulatory assistance
- Pre-operative heparin use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heparin Management for Cardiopulmonary Bypass in Cardiac Surgery: A Prospective, Comparative and Randomized Study Evaluating a Dosage Based on the Ideal Body Weight in Obese Patients
The optimal heparin regimen during cardiopulmonary bypass (CPB) has not been well established in obese patients.
Results of a preview study show that the standard heparin management based on total body weight in obese patients during CPB resulted in excessive heparin level, which could lead to excessive postoperative bleeding.
Read more
To avoid this overdosing, an initial heparin bolus based on ideal body weight in obese patients was proposed.
The main objective of the study is to evaluate the effects of heparin injection, based on ideal body weight, on intraoperative plasma heparin levels and activated coagulation time (ACT) in a population of obese patients, compared to a group of obese patients undergoing CPB surgery with heparin management based of total body weight.
The secondary objectives are to evaluate the relationship between heparin level and ACT in each group of patients and at different time points during CPB, and to compare the incidence of bleeding, intraoperative transfusions and complications in the two groups of patients.
- Being tested
- Heparin, IV route, based on patients body weights (UI/kg), Cardiopulmonary bypass, Protamin administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin, IV route, based on patients body weights (UI/kg)Drug
Cardiopulmonary bypassProcedure or surgery
Protamin administrationDrug
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Obese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the dosage of 340 UI/kg based on ideal body weight of the obese patients.
The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on ideal body weight, to maintain this target during the CPB. Receives: Drug: Heparin, IV route, based on patients body weights (UI/kg); Procedure: Cardiopulmonary bypass; Drug: Protamin administration |
| Control group | Active comparator | Obese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the usual dosage of 300 UI/kg based on total body weight of the obese patients.
The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on total body weight, to maintain this target during the CPB. Receives: Drug: Heparin, IV route, based on patients body weights (UI/kg); Procedure: Cardiopulmonary bypass; Drug: Protamin administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma heparin level (anti-Xa activity, in UI/ml)
Measured: at 3 minutes after the first heparin injection
Secondary outcomes (4)
Activated Clotting Time
Measured: during the intervention
Plasma Antithrombin III level
Measured: during the intervention at 3 minutes after heparin injection (=T1)
numbers of labile blood products transfused
Measured: during the surgery and the first 24 hours in ICU
Postoperative bleedings
Measured: during the first 24 hours in ICU, based on chest tube outputs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675647
- Sponsor's protocol ID
- 6124
- Other IDs
- 2015-003138-28, 2015
- Acronym
- HEPOIRINE
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2015
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Vienne M, Haas E, Wipf T, Grunebaum L, Levy F, Sattler L, Hoang Minh T, Severac F, Tacquard C, Collange O, Mertes PM, Steib A. Adjusted calculation model of heparin management during cardiopulmonary bypass in obese patients: A randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):613-620. doi: 10.1097/EJA.0000000000000784.
PubMed 29521662
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin Management for Cardiopulmonary Bypass in Cardiac Surgery: A Prospective, Comparative and Randomized Study Evaluating a Dosage Based on the Ideal Body Weight in Obese Patients
- ClinicalTrials.gov ID
- NCT02675647
- Acronym / sponsor ID
- HEPOIRINE / 6124
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Feb 2016 (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 optimal heparin regimen during cardiopulmonary bypass (CPB) has not been well established in obese patients.
Results of a preview study show that the standard heparin management based on total body weight in obese patients during CPB resulted in excessive heparin level, which could lead to excessive postoperative bleeding.
To avoid this overdosing, an initial heparin bolus based on ideal body weight in obese patients was proposed.
The main objective of the study is to evaluate the effects of heparin injection, based on ideal body weight, on intraoperative plasma heparin levels and activated coagulation time (ACT) in a population of obese patients, compared to a group of obese patients undergoing CPB surgery with heparin management based of total body weight.
The secondary objectives are to evaluate the relationship between heparin level and ACT in each group of patients and at different time points during CPB, and to compare the incidence of bleeding, intraoperative transfusions and complications in the two groups of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Heparin, IV route, based on patients body weights (UI/kg), Procedure: Cardiopulmonary bypass, Drug: Protamin administrationObese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the dosage of 340 UI/kg based on ideal body weight of the obese patients. The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on ideal body weight, to maintain this target during the CPB. |
| Control group | Active comparator | Drug: Heparin, IV route, based on patients body weights (UI/kg), Procedure: Cardiopulmonary bypass, Drug: Protamin administrationObese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the usual dosage of 300 UI/kg based on total body weight of the obese patients. The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on total body weight, to maintain this target during the CPB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Obese patients (BMI ≥ 30 kg/m²)
- Planned cardiac surgery under cardiopulmonary bypass
- Coronary-artery bypass graft, or valve surgery)
- Age ≥ 18 yo
Key exclusion criteria (6 listed)
- Allergy to heparin
- Emergency surgical intervention
- Redo surgery
- Heart transplantation
- Surgery for circulatory assistance
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 |
|---|---|---|
| Heparin, IV route, based on patients body weights (UI/kg) | Drug | Control group, Intervention group |
| Cardiopulmonary bypass | Procedure or surgery | Control group, Intervention group |
| Protamin administration | Drug | Control group, Intervention group |
Primary outcome
Plasma heparin level (anti-Xa activity, in UI/ml)
Time frame: at 3 minutes after the first heparin injection
4 secondary outcomes
Activated Clotting Time
Time frame: during the intervention
Plasma Antithrombin III level
Time frame: during the intervention at 3 minutes after heparin injection (=T1)
numbers of labile blood products transfused
Time frame: during the surgery and the first 24 hours in ICU
Postoperative bleedings
Time frame: during the first 24 hours in ICU, based on chest tube outputs
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 16 Mar 2026.
- Results publication: PubMed 29521662Vienne M, Haas E, Wipf T, Grunebaum L, Levy F, Sattler L, Hoang Minh T, Severac F, Tacquard C, Collange O, Mertes PM, Steib A. Adjusted calculation model of heparin management during cardiopulmonary bypass in obese patients: A randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):613-620. doi: 10.1097/EJA.0000000000000784.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heparin, IV route, based on patients body weights (UI/kg), Cardiopulmonary bypass and Protamin administration in people with Cardiac Surgery and Cardiopulmonary Bypass, run by University Hospital, Strasbourg, France at 1 site in France.
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 6 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 16 Mar 2026. 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 France. 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?
Plasma heparin level (anti-Xa activity, in UI/ml) (time frame: at 3 minutes after the first heparin injection). 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 NCT02675647, 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 16 Mar 2026.