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Pericardial Tissue and the Post Pericardiotomy Syndrome

Pericardial Tissue and the Post Pericardiotomy Syndrome - Pericardial tissue and PPS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44142
Enrollment
40
Registered
2016-03-22
Start date
2016-06-10
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

postpericardial injury syndrome

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) For rethoracotomy patients: - Adult (*18 years) patients undergoing a rethoracotomy for any reason, within 90 days after initial cardiac surgery.;2) For patients undergoing a first sternotomy: - Adult (*18 years) patients undergoing an isolated CABG (5 patients) or isolated valve surgery (5 patients) via a full sternotomy for the first time.

Exclusion criteria

Exclusion criteria: 1) For patients undergoing a rethoracotomy: - Patients undergoing a rethoracotomy within 24 hours after initial cardiac sugery (24 hours after the first incision) - Patients undergoing pericardial surgery (pericardial window or pericardiectomy) as initial surgery because of recurrent pericardial fluid or a pericardial disease. - Patients undergoing a heart transplantation as initial surgery (because of the routine use of anti-inflammatory agents postoperatively) - Patients undergoing a LVAD implantation as initial surgery - Patients undergoing valve replacement as initial surgery because of endocarditis - Patients with a medical history of pericarditis - Patients with a medical history of auto-immune disease and who use corticosteroids on a daily basis;2) For patients undergoing a first sternotomy: - Patients undergoing an emergency operation - Patients with a medical history of pericarditis - Patients with a medical history of auto-immune disease and who use corticosteroids on a daily basis - Patients with endocarditis - Patients with pericardial effusion on the preoperative echo.

Design outcomes

Primary

MeasureTime frame
1. The following histology studies of pericardial tissue in patients with and without PPS will be performed: - Hematoxylin and eosin staining (HE stain) - CD3, CD20 and CD68 staining (to identify macrophages, T- and B-lymphocytes) - General description of findings by the pathologist. 2. Diagnosing PPS

Secondary

MeasureTime frame
To assess biomarkers that are associated with PPS by collecting 4 blood- and 1 pericardial fluid samples. The material will be stored in the central biobank of the UMC Utrecht, because at this time it is unclear which biomarkers should be investigated. This also depends partially on findings at histology studies.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)