The pericardial perfusie study, to evaluate the safety and feasability of postoperative pericardial perfusion with NaCl 0.9% to reduce blood loss after cardiac surgery

The pericardial perfusie study, to evaluate the safety and feasability of postoperative pericardial perfusion with NaCl 0.9% to reduce blood loss after cardiac surgery - Pericardial perfusion study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35280

Enrollment

Registered

2011-10-24

Start date

2011-11-01

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

blood loss

Interventions

Insertion of an extra (inflow) drain in the pericardium, over which NaCl 0.9% will flow with an initial rate of 500mL/hour. The inflow will be ajusted according to the outflow, with an one on one ra

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All adult patients undergoing cardiac surgery

Exclusion criteria

Exclusion criteria: emergency surgery, history of bleeding diathesis or coagulopathy, participation in any study involving an investigational drug or device, inability to understand the study information and/or sign informed consent.

Design outcomes

Primary

Measure	Time frame
Evaluation of the feasibility and safety of pericardial perfusion.	—

Secondary

Measure	Time frame
Peroperative: - Duration operation - Duration of CPB usage - Duration of aortic clamping Postoperative: - Amount of blood loss within 24 hours after surgery - Temperature - Radiology and echography	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)