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Completed

NCT Number: NCT03885193

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. postoperative bleeding in cardiac surgery

    Time frame: First 24 hours

    Compare HMS Plus and ACT Plus devices on postoperative bleeding in cardiac surgery

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: POC/HMS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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