Impact of HMS Plus Device on Postoperative Blood Loss During Cardiac Surgery

NCT ID: NCT03885193

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 188 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2019-11-14

Brief 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.

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.

Conditions

Cardiac Surgical Procedure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

HMS plus group

HMS plus device is employed to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB).

No interventions assigned to this group

ACT plus group

ACT plus device is employed to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients undergoing cardiac surgery with cardiopulmonary bypass (valve procedure, coronary artery bypass grafting (CABG), heart transplantation,..)

Exclusion Criteria

• Minors
• Isolated aortic valve procedure unless high risk of hemorrhage (endocarditis, redo surgery)
• Contra indication to heparin and/or protamine

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

RC19_0063

Identifier Type: -

Identifier Source: org_study_id