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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36910

Enrollment

Registered

2012-10-24

Start date

2013-03-25

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antagonising heparin coagulation disorder

Interventions

Group A: Low ratio Protamine-to-heparin dosing ratio of 0.8 Group B: High ratio Protamine-to-heparin dosing ratio of 1.3

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients undergoing low-moderate risk cardiac surgery (coronary artery bypass graft (CABG), and older than 18 years old

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Postoperative 24-hour blood loss assessed by wound drainage.	—

Secondary

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)