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Postoperative heparin administration to prevent pulmonary vein stump thrombus after left side anatomical pulmonary resection: Multicenter Randomized Phase II trial

Postoperative heparin administration to prevent pulmonary vein stump thrombus after left side anatomical pulmonary resection: Multicenter Randomized Phase II trial - PV STUDY

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031230739
Enrollment
340
Registered
2024-03-27
Start date
2024-03-27
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

Patients who underwent left side anatomical pulmonary resection Lung Cancer

Interventions

Postoperative heparin administration

Sponsors

Suzuki Kenji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The first registration inclusion criteria 1) Aged 18 to 85 years old on the day of the registration. 2) Left upper lobectomy, left lower lobectomy, left side lobectomy with an additional segmentectomy or wedge resection fot the other lobe, pneumonectomy, left upper division segmentectomy, lingular segmentectomy are planed. 3) No history of previous anatomical thoracic surgery for the left side. 4) Performance status of ECOG is 0 or 1. 5) The latest blood examination result within 30 days prior to the first registration meets all of the following. i. White blood cell count >= 3,000/mm3 and = 8.0 g/dL iii. Platelet count >= 100,000/mm3 iv. Total bilirubin <= 2.0 mg/dL v. AST <=100 U/L vi. ALT<=100 U/L vii. Serum creatinine <= 1.5 mg/dL viii. normal APTT (APTT<= 1.2 fold) 6) No previous history of severe bronchial asthma. 7) No allergic history for contrast agent. 8) Written consent to participate in the study has been obtained from the patient. The second registration inclusion criteria 1) Left upper lobectomy, left lower lobectomy, left side lobectomy with an additional segmentectomy or wedge resection fot the other lobe, pneumonectomy, left upper division segmentectomy, lingular segmentectomy were performed. 2) No aggravation of hematoma on the postoperative chest X ray. 3) Serous or pale blooded thoracic effusion from the chest drainage tube. 4) No aggravation of subcutaneous emphysema or no contenuous air leak which needs reoperation.

Exclusion criteria

Exclusion criteria: The first registration exclusion criteria 1) History of heparin hypersensitivity or history of thrombothytopenia. 2) History of hert failure, unstable angina (angina that developed or worsened within the last 6 months) or a myocardial infarction within 6 months. 3) History of cerebral infarction. 4) Poorly controlled diabetes mellitus (urin sugar >=10g / day or fasting blood sugar >=150mg / dl under the insulin use). 5) Need for preoperative heparinization to replace the preoperative anti-platelet or anti-coagulant drug administration. 6) Receiving continuous systemic administration (oral or intravenous) of steroids. 7) History of diseases with bleeding tendency or coagulation abnormality. 8) History for the treatment of refractory ulcer. 9) Female during pregnancy or lactation. 10) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make participation in the study difficult. 11) Patients jugded unsuitable for enrolling this study by research director. The second registration exclusion criteria 1) Surgical resection for pericardium, diaphragm, and chest wall 2) Bronchoplastic procedure or pulmonary vessel reconstruction 3) Intrapericardial procedure for pulmonary vein resection 4) Complete or extensive adhesion in the thoracic cavity 5) Patients jugded unsuitable for enrolling this study by research director

Design outcomes

Primary

MeasureTime frame
Frequency of the pulmonry vein stump thrombus after left side anatomical pulmonary resection.

Secondary

MeasureTime frame
Frequency of the systemic thromboembolic event including cerebral infarction at the early phase after surgical resection (within 30 day after surgery). Percentage of the shrinkage of pulmonary vein stump thrombus. Frequency of the pulmonry vein stump thrombus and frequency of the systemic thromboembolic event including cerebral infarction at the late phase after surgical resection (at 3,6,12 months after surgery). Safety analysis for postoperative heparin administration (duration of chest tube drainage, bleeding related complication, re-insertion of chest drainage tube). Respiratory related complications. Postoperative 30 day / 90 day mortaliry rate.

Contacts

Public ContactAritoshi Hattori

Juntendo Hospital, Juntendo University School of Medicine

ahattori@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

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