Cardiac Surgical ProcedurePOC/HMSNCT03885193
Impact of HMS Plus Device on Postoperative Blood Loss During Cardiac Surgery
An observational study of Cardiac Surgical Procedure, run by Nantes University Hospital at 1 site in France.
Trial summary
Activated clotting times (ACT) is employed most commonly to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB). However, many studies have demonstrated a lack of correlation between plasma heparin levels and ACT during CPB. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiac Surgical Procedure
- How many people
- 188 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 14 Nov 2019
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective cardiac surgery with cardiopulmonary bypass
Who may be able to join
- Patients undergoing cardiac surgery with cardiopulmonary bypass (valve procedure, coronary artery bypass grafting (CABG), heart transplantation,..)
Who cannot join
- Minors
- Isolated aortic valve procedure unless high risk of hemorrhage (endocarditis, redo surgery)
- Contra indication to heparin and/or protamine
Trial locations and contacts
1 site in 1 country.
About this study
Activated clotting times (ACT) is employed most commonly to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB). However, many studies have demonstrated a lack of correlation between plasma heparin levels and ACT during CPB.
HMS Plus device estimate the free plasma heparin level from a whole-blood sample and also include the dose of protamine necessary to neutralize the circulating heparin at the end of CPB. It could predict a higher heparin dose and lower protamine dose but it's interest on postoperative bleeding and perioperative transfusion is unclear.
Read the detailed description
Adult cardiac surgery is often complicated by elevated blood losses that account for elevated transfusion requirements. Perioperative bleeding and transfusion of blood products are major risk factors for morbidity and mortality.
Cardiac surgery is a challenge in the management of coagulation because of the requirement for both a fully anticoagulated state for CPB and a return-to-normal hemostasis at its conclusion. Conditions during CPB, such as hemodilution, hypothermia, platelet activation and coagulopathy are know to cause falsify elevated ACT readings. For these reasons, relying on the ACT alone may lead to inadequate anticoagulation.
Moreover, no consensus about the monitoring or level of anticoagulation required has been reached. Similarly, the neutralization of heparin is performed with protamine (dose/dose). This empirical approach does not include inter- and intra-individual variations, which can involve bleeding complications. By using the HMS Plus, heparin and protamine dosing are individualized based on each patient's responsiveness to heparin, eliminating the need for empiric weight-based dosing.
HMS Plus provided a rapid assessment of heparin concentration that correlated well with anti-Xa assays. This could attenuates this hemostatic activation by decreasing excessive generation of thrombin and plasmin. Also, this ensures preservation of coagulation factors and decreases thrombin-mediated consumption and activation of platelets during CPB.
HMS Plus is ability to calculate the amount of circulating heparin at the end of CPB and give the exact dose of protamine necessary to neutralize the heparin. Targeted dosing can prevent excessive protamine administration and reduce protamine-induced platelet dysfunction.
In a meta-analysis of 4 randomized controlled trials involving a total of 507 patients, postoperatively blood loss was lower in the HMS group compared with the control group. But the supporting studies were limited by small sample sizes, outdated practice techniques, not involve surgery at risk and have liberal transfusion practices. Moreover, studies observed errors in calculating the heparin bolus dose with HMS Plus if patient had an inadequate antithrombin level. The administration of more heparin is a cause of heparin rebound in the postoperative period and potentially was increasing the risk for bleeding.
So, it would be necessary to compare ACT Plus and HMS Plus devices on postoperatively bleeding in a study involve patients at risk to bleeding and with a transfusion protocol.
- Conditions
- Cardiac Surgical Procedure
- Keywords
- anticoagulation, cardiopulmonary bypass, heparin, protamine, postoperatively bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HMS plus group | HMS plus device is employed to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB). | |
| ACT plus group | ACT plus device is employed to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB). |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative bleeding in cardiac surgery
Compare HMS Plus and ACT Plus devices on postoperative bleeding in cardiac surgery
Measured: First 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 May 2019
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885193
- Sponsor's protocol ID
- RC19_0063
- Acronym
- POC/HMS
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2019
- Last updated
- 4 Mar 2021
- 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 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of HMS Plus Device on Postoperative Blood Loss During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03885193
- Acronym / sponsor ID
- POC/HMS / RC19_0063
- Conditions
- Cardiac Surgical Procedure
- Keywords
- anticoagulation, cardiopulmonary bypass, heparin, protamine, postoperatively bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 21 Mar 2019 (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.
Activated clotting times (ACT) is employed most commonly to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB). However, many studies have demonstrated a lack of correlation between plasma heparin levels and ACT during CPB.
HMS Plus device estimate the free plasma heparin level from a whole-blood sample and also include the dose of protamine necessary to neutralize the circulating heparin at the end of CPB. It could predict a higher heparin dose and lower protamine dose but it's interest on postoperative bleeding and perioperative transfusion is unclear.
Detailed description
Adult cardiac surgery is often complicated by elevated blood losses that account for elevated transfusion requirements. Perioperative bleeding and transfusion of blood products are major risk factors for morbidity and mortality.
Cardiac surgery is a challenge in the management of coagulation because of the requirement for both a fully anticoagulated state for CPB and a return-to-normal hemostasis at its conclusion. Conditions during CPB, such as hemodilution, hypothermia, platelet activation and coagulopathy are know to cause falsify elevated ACT readings. For these reasons, relying on the ACT alone may lead to inadequate anticoagulation.
Moreover, no consensus about the monitoring or level of anticoagulation required has been reached. Similarly, the neutralization of heparin is performed with protamine (dose/dose). This empirical approach does not include inter- and intra-individual variations, which can involve bleeding complications. By using the HMS Plus, heparin and protamine dosing are individualized based on each patient's responsiveness to heparin, eliminating the need for empiric weight-based dosing.
HMS Plus provided a rapid assessment of heparin concentration that correlated well with anti-Xa assays. This could attenuates this hemostatic activation by decreasing excessive generation of thrombin and plasmin. Also, this ensures preservation of coagulation factors and decreases thrombin-mediated consumption and activation of platelets during CPB.
HMS Plus is ability to calculate the amount of circulating heparin at the end of CPB and give the exact dose of protamine necessary to neutralize the heparin. Targeted dosing can prevent excessive protamine administration and reduce protamine-induced platelet dysfunction.
In a meta-analysis of 4 randomized controlled trials involving a total of 507 patients, postoperatively blood loss was lower in the HMS group compared with the control group. But the supporting studies were limited by small sample sizes, outdated practice techniques, not involve surgery at risk and have liberal transfusion practices. Moreover, studies observed errors in calculating the heparin bolus dose with HMS Plus if patient had an inadequate antithrombin level. The administration of more heparin is a cause of heparin rebound in the postoperative period and potentially was increasing the risk for bleeding.
So, it would be necessary to compare ACT Plus and HMS Plus devices on postoperatively bleeding in a study involve patients at risk to bleeding and with a transfusion protocol.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMS plus group | – | –HMS plus device is employed to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB). |
| ACT plus group | – | –ACT plus device is employed to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery with cardiopulmonary bypass (valve procedure, coronary artery bypass grafting (CABG), heart transplantation,..)
Key exclusion criteria (3 listed)
- Minors
- Isolated aortic valve procedure unless high risk of hemorrhage (endocarditis, redo surgery)
- Contra indication to heparin and/or protamine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative bleeding in cardiac surgery
Time frame: First 24 hours
Compare HMS Plus and ACT Plus devices on postoperative bleeding in cardiac 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 4 Mar 2021.
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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?
An observational study of Cardiac Surgical Procedure, run by Nantes University Hospital 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 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 4 Mar 2021. 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.
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?
postoperative bleeding in cardiac surgery (time frame: First 24 hours). 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 4 Mar 2021.