Prevention of postoperative bleeding after complex pediatric cardiac surgery by early administration of fibrinogen, prothrombin complex and platelets: a prospective observational study

Prevention of postoperative bleeding after complex pediatric cardiac surgery by early administration of fibrinogen, prothrombin complex and platelets: a prospective observational study - Bleeding in complex pediatric cardiac surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00018109

Enrollment

Registered

2019-10-29

Start date

2017-04-02

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Bleeding after complex pediatric cardiac surgery with cardiopulmonary Bypass. Thrombosis after coagulation therapy, mortality, re-operation

Interventions

Group 1: Coagulation therapy after cardic bypass surgery

Eligibility

Sex/Gender

All

Age

1 Days to 6 Years

Inclusion criteria

Inclusion criteria: Cardiopulmonary Bypass > 90 minutes in neonates, cyanotic cardiac disease, reoperation, aortic or hypothermic surgery (< 32°C)

Exclusion criteria

Exclusion criteria: Pre-existing coagulation disorders or anticoagulant or antiplatelet therapy.

Design outcomes

Primary

Measure	Time frame
Evaluate the efficacy of an early preventive administration of coagulation factors after CPB (Cardiopulmonary bypass) in the OR in accordance with clinical bleeding evaluation and its effects on TEG (thromboelastography) and standard coagulation Parameters at the OR and after 12 hours on ICU.	—

Secondary

Measure	Time frame
Re-operation, outcome, thrombosis	—

Countries

Germany

Contacts

Public ContactNils Dennhardt

Medizinische Hochschule Hannover, Klinik für Anästhesiologie und Intensivmedizin

dennhardt.nils@mh-hannover.de0049 17615323314

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 24, 2026