The effect of a high and low protamine-to-heparin dosing on perioperative hemostasis: a randomized clinical trial

Completed

• Conditions: Antagonising heparin; coagulation disorder; 10011082; 10007593

• Registration Number: NL-OMON36910
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 98

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Postoperative 24-hour blood loss assessed by wound drainage.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Hemostatic monitoring:<br /><br>ROTEM: Intem, Heptem, Extem, Fibtem<br /><br>* Clotting Time (CT),<br /><br>* Maximum Clot Firmness (MCF)<br /><br>* Clot Formation Time (CFT)<br /><br>Classical coagulation tests:<br /><br>* aPTT<br /><br>* PT<br /><br>Activated Clotting Time (ACT)<br /><br>Anti-Xa<br /><br>Heparin concentration<br /><br>* Patient demographics<br /><br>* Surgery time, CPB time, cross-clamp time<br /><br>* Transfusion of blood products</p><br>