Different strategies of heparin management during cardiopulmonary bypass: the effects on anticoagulation and postoperative hemostasis

Different strategies of heparin management during cardiopulmonary bypass: the effects on anticoagulation and postoperative hemostasis - HepCon study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34395

Enrollment

Registered

2010-08-30

Start date

2010-12-09

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Valve disease valvular obstruction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Patients undergoing valve replacement and/or valve repair surgery * Age 18-85 years * Informed consent

Exclusion criteria

Exclusion criteria: * Re-operations * Emergency operation * Patients with insulin-dependent diabetes mellitus * Patients with a history of hematologic, hepatic or renal diseases * Patients with Body Mass Index (BMI) over 30 kg/m2

Design outcomes

Primary

Measure	Time frame
* Reduction in postoperative protamine usage	—

Secondary

Measure	Time frame
* Improvement of postoperative hemostasis * Hemostatic monitoring (ROTEM Clotting Time (CT), ROTEM Maximum Clot Firmness (MCF) and the shear elastic modulus G (all ROTEM parameters) * Pre-CPB and post-CPB aPTT, PT and Clauss fibrinogen test * Heparin concentration and HR-ACT (both HMS), ACT (Hemochron) * C-reactive protein (CRP), platelet count, perioperative transfusion requirements, perioperative fluid balance * Patient demographics * Surgery time, CPB time, cross-clamp time	—

Measure

Time frame

* Improvement of postoperative hemostasis * Hemostatic monitoring (ROTEM Clotting Time (CT), ROTEM Maximum Clot Firmness (MCF) and the shear elastic modulus G (all ROTEM parameters) * Pre-CPB and post-CPB aPTT, PT and Clauss fibrinogen test * Heparin concentration and HR-ACT (both HMS), ACT (Hemochron) * C-reactive protein (CRP), platelet count, perioperative transfusion requirements, perioperative fluid balance * Patient demographics * Surgery time, CPB time, cross-clamp time

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Countries

Netherlands

Outcome results