Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial
- Conditions
- Lung Cancer
- Interventions
- Procedure: Autologous Blood PatchProcedure: Standard of Care (per Physician)
- Registration Number
- NCT04954625
- Lead Sponsor
- Rush University Medical Center
- Brief Summary
A postoperative autologous blood patch (ABP) intervention trial for patients who underwent lung resection for cancer to examine its effectiveness in preventing a prolonged air leak.
AIM 1: To determine the safety and efficacy of autologous blood patch (ABP) as a means to reduce the rate of prolonged air leak (PAL) after lung cancer resection
AIM 2: To prospectively examine variation in morbidity and quality of life between patients with and without a PAL
- Detailed Description
The plan for this trial is to establish the safety and efficacy of ABP as a means of reducing PAL following lung cancer resection. Patients with an air leak on the morning of postoperative day 3 after elective lung resection for cancer will be randomized to ABP on postoperative day 3 and day 4 (if an air leak remains present), or standard care (n=60 per arm). This will be a multi-institutional randomized, controlled trial open for enrollment at centers in the United States and Canada. The study methods and design are compliant with the Consolidated Standards of Reporting Trials (CONSORT).
Subjects will be consented on postoperative day 3, with autologous blood patch intervention occurring on day 3 or day 4. If subjects are randomized to the ABP arm of the trial, they will receive 60-100 ml of autologous blood sterilely drawn from a peripheral vein and immediately instilled into the chest tube.
Subjects will then follow up either in clinic or via telephone to answer the questionnaire. If the subject is being seen in person, they will be handed a questionnaire form to complete. This form will be kept and stored as source documentation. If the patient is answering the questionnaire via telephone, the study team personnel will record their answers on the questionnaire form, indicating it was completed by the subject but recorded by study team personnel. A telephone encounter note will be recorded and stored as source with the completed questionnaire. Follow up occurs at 30 days (+/-5 days) postoperatively.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 60
- Patients who underwent elective wedge resection, segmentectomy, lobectomy, or bilobectomy for suspected non-small cell lung cancer
- Patients that have reviewed and signed the Informed Consent Form, had an opportunity to ask questions, and consent to have their de-identified data included in the study
- Patients who have an air leak on the morning of postoperative Day 3
- Age ≥18 years old
- Patients who undergo pneumonectomy, sleeve lobectomy, chest wall or diaphragm resection, or bilateral procedures.
- Age < 18 years old
- Women who are pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Autologous Blood Patch Autologous Blood Patch 60-120ml of patient's blood will be drawn and inserted into patient's chest tube. A minimum of 60ml of blood is required, with the optimal amount of blood being 120ml. Standard of Care (Per physician) Standard of Care (per Physician) Chest tube remains intact without blood patch.
- Primary Outcome Measures
Name Time Method Prolonged Air Leak >5 days Within 30 Days Definition of prolonged air leak: air leak present at 5 days or greater
30-day Mortality Within 30 Days Survival status within 30 days consent.
Readmission within 30 days Within 30 Days Determination of whether the patient was readmitted after discharge within 30 days.
Hospital Length of Stay Within 30 Days Number of days patient was admitted inpatient
In hospital mortality Within 30 Days Survival status while inpatient.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States