De effecten van verschillende doseringsverhoudingen van middelen die de stolling remmen of activeren op bloedverlies tijdens hartchirurgie.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22454

Enrollment

Registered

2012-07-13

Start date

2012-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Cardiac surgery

Interventions

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. This administration is based on the

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing coronary artery bypass graft (CABG) surgery; 2. Age 18-85 years; 3. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Re-operations; 2. Emergency operation; 3. Patients with a history of hematologic disorders or renal replacement therapy; 4. 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
1. Hemostatic monitoring; 2. ROTEM: Intem, Heptem, Extem, Fibtem; A. Clotting Time (CT); B. Maximum Clot Firmness (MCF); C. Clot Formation Time (CFT). 3. Classical coagulation tests: A. aPTT; B. PT. 4. Activated Clotting Time (ACT); 5. Anti-Xa; 6. Heparin concentration; 7. Antithrombin III; 8. Thrombin generation; 9. Patient demographics; 10. Surgery time, CPB time, cross-clamp time; 11. Transfusion of blood products.	—

Measure

Time frame

1. Hemostatic monitoring; 2. ROTEM: Intem, Heptem, Extem, Fibtem; A. Clotting Time (CT); B. Maximum Clot Firmness (MCF); C. Clot Formation Time (CFT). 3. Classical coagulation tests: A. aPTT; B. PT. 4. Activated Clotting Time (ACT); 5. Anti-Xa; 6. Heparin concentration; 7. Antithrombin III; 8. Thrombin generation; 9. Patient demographics; 10. Surgery time, CPB time, cross-clamp time; 11. Transfusion of blood products.

—

Contacts

Public ContactA.B.A. Vonk

Dept. of Cardio-thoracic surgery VU University Medical Center De Boelelaan 1117

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)