Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03885193 |
| Other study ID # |
RC19_0063 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2019 |
| Est. completion date |
November 14, 2019 |
Study information
| Verified date |
March 2021 |
| Source |
Nantes University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
