Randomized controlled trial of octreotide and Factor XIII preparation against refractory pleural effusion

Randomized controlled trial of octreotide and factor XIII preparation against refractory pleural effusion after pediatric cardiac surgery - Randomized controlled trial of octreotide and factor XIII preparation against refractory pleural effusion after pediatric cardiac surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031180305

Enrollment

Registered

2019-03-15

Start date

2014-12-04

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Refractory pleural effusion after surgery Refractory pleural effusion

Interventions

1. Infusion intravenous administration of fibrogen Fibrogamine is intravenously infused at 0.5 ml / kg / day in 0.5 hour 2. Intravenous drip injection of sandostatin Sandostatin 2.0 mcg / kg / h Intra

octreotide, Factor 13 factor preparation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. patients underwent cardiovascular surgery 2. Patients under 7 years of age at registration 3. Patients who satisfy any of the following drain drainage (pleural effusion) 3-1.Pleural effusion of 20 ml / kg / day or more after day 4 postoperative 3-2.Pleural effusion of 6 ml / kg / day or more after day 7 postoperative 4.Patients with consent from parents of patients

Exclusion criteria

Exclusion criteria: 1.Patients who had re-implanted drain after surgery 2.Cases in which lymphatic vessel damage is clearly suspected after side open thoracotomy 3.Patients with ECMO 4. Patients without sternum closure 5. Patients with congenital chylothorax 6.Patients diagnosed with or suspected of neonatal necrotizing enterocolitis at registration 7.Hemolytic anemia at the time of enrollment, patients diagnosed or suspected as immunodeficiency 8. Patients whose daily pleural drainage volume has not been measured every day from postoperative to enrolled

Design outcomes

Primary

Measure	Time frame
Daily pleural drainage volume per body weight at the 6 th day after the start of the study treatmen	—

Secondary

Measure	Time frame
1.Amount of pleural effusion per body surface area at 6th day after the start of the study treatment 2.Presence or absence of patients whose pleural effluent volume at the 6th day after commencement was 1/2 or less of the day before the start of the study treatment 3.Presence or absence of surgical treatment for pleural effusion 4.Presence or absence of re-intervention	—

Contacts

Public ContactKaneko Yukihiro

National Center for Child Health and Development

kaneko-y@ncchd.go.jp+81-3-3416-0181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026