Comparison of a single dose fibrinogen with placebo and the number of blood transfusions after ascending aorta surgery (FIBTEG study)

Comparison of a single dose fibrinogen with placebo and the number of blood transfusions after ascending aorta surgery (FIBTEG study) - Bloodtranfusions after aortic surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41387

Enrollment

Registered

2014-04-22

Start date

2014-08-28

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

loss of functionality of the thoracic aorta postoperative coagulopathy

Interventions

During the operation, clotting is measured with point of care with TEG, and the usual intra-operative hemostasis protocol was followed (transfusion of blood products in the form of blood plasma (FFP

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * > 18 years * Competent * Scheduled for ascending aorta replacement using CPB * Signed informed consent

Exclusion criteria

Exclusion criteria: * Presence thrombosis or previous myocardial infarction * Severe recorded atherosclerosis * Hypersensitivity to any component of FC * Congenital or acquired impaired clotting * Hypofibrinogenemia (

Design outcomes

Primary

Measure	Time frame
Number of transfused allogenic blood products, up to 24 hours after surgery.	—

Secondary

Measure	Time frame
Postoperative blood loss (= thoracic drainage volume) up to 24 hours after surgery. * Re-operation during postoperative hospitalization. * Admission time in Intensive Care Unit (ICU) and hospital. * Hospital mortality	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)