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Prospective analysis of the influence of the heart-lung machine on factor XII activity in the blood and its functional effects on coagulation capacity, bleeding and thrombosis rates

Prospective analysis of the influence of the heart-lung machine on factor XII activity in the blood and its functional effects on coagulation capacity, bleeding and thrombosis rates

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00034174
Enrollment
20
Registered
2024-04-30
Start date
2024-06-25
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

A prolonged aPTT often results in postoperatively inadequate anticoagulation, which could lead to an increased rate of thromboembolic events.

Interventions

Group 1: Patients undergoing major cardiac surgery using the heart-lung machine

Sponsors

LMU Klinikum München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients undergoing major cardiac surgery with intraoperative use of the heart-lung machine - Consent of the patient or caregiver - Age > 18 years

Exclusion criteria

Exclusion criteria: - Refusal to participate in the study by the patient or caregiver - Age < 18 years - Congenital or acquired coagulation disorders (both pro- and anticoagulatory) - Blood-thinning medication in a time window of less than 12 hours before the operation, with the exception of antiplatelet agents

Design outcomes

Primary

MeasureTime frame
Factor XII activity preoperatively versus after the end of the extracorporeal perfusion time

Secondary

MeasureTime frame
- Correlation of factor XII activity with aPTT - Correlation of factor XII activity with CT INTEM - Correlation of factor VIII activity with CT INTEM or aPTT - Correlation of factor V activity with CT INTEM or aPTT - Correlation of factor activities with thromboembolic events or bleeding events - Correlation of factor activities with transfusion volumes

Countries

Germany

Contacts

Public ContactPhilipp Groene

LMU Klinikum München

philipp.groene@med.uni-muenchen.de+49 89 4400 73410

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026