Does a low protamine-to-heparin ratio lead to a reduction in postoperative blood loss and improved postoperative hemostasis when compared to a high protamine-to-heparin ratio in cardiothoracic surgery?
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative 24-hour blood loss assessed by wound drainage.
Secondary outcome
Hemostatic monitoring:
ROTEM: Intem, Heptem, Extem, Fibtem
* Clotting Time (CT),
* Maximum Clot Firmness (MCF)
* Clot Formation Time (CFT)
Classical coagulation tests:
* aPTT
* PT
Activated Clotting Time (ACT)
Anti-Xa
Heparin concentration
* Patient demographics
* Surgery time, CPB time, cross-clamp time
* Transfusion of blood products
Background summary
Prior to, and during cardiopulmonary bypass, heparin is transfused in order to
avoid massive coagulation activation by the contact surface of the
heart-lung-machine. Heparin dosing is commonly based on bodyweight and
activated clotting time (ACT). After cardiopulmonary bypass, protamine is
transfused to neutralize heparin, thereby reactivating the clotting cascade.
Protamine forms a 1:1 salt complex with heparin, but may exhibit an intrinsic
anticoagulant activity after overdosing. According to current guidelines,
protamine dosing is performed in a 1.0-1.3:1.0 ratio with heparin. However, our
own observations and several literature reports suggest that, due to the
degrading and loss of heparin during surgery, protamine is usually overdosed.
The consequent overdosing of protamine might deteriorate postoperative
hemostasis. The present study investigates whether the use of a lower dosing
protamine-to-heparin dosing ratio (0.8) is superior as compared to a high
protamine-to-heparin dosing ratio (1.3) with respect to postoperative
hemostasis, blood loss and transfusion.
Study objective
Does a low protamine-to-heparin ratio lead to a reduction in postoperative
blood loss and improved postoperative hemostasis when compared to a high
protamine-to-heparin ratio in cardiothoracic surgery?
Study design
Multicenter, randomised, single-blinded clinical study
Intervention
Group A: Low ratio Protamine-to-heparin dosing ratio of 0.8
Group B: High ratio Protamine-to-heparin dosing ratio of 1.3
Study burden and risks
Randomisation into one of the two protamine:heparin dosing groups.
Three extra bloodsample drawings using an existing arterial line during the
surgical procedure.
The risk of randomisation and extra blood sampling are estimated as minimal.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Patients undergoing low-moderate risk cardiac surgery (coronary artery bypass graft (CABG), and older than 18 years old
Exclusion criteria
Re-operations, emergency operations, patients with a history of hematologic or renal diseases and/or patients with a body mass index (BMI) below 18 kg/m2 or above 35 kg/m2
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-003359-12-NL |
| CCMO | NL40764.029.12 |
| Other | NRT nummer in aanvraag |