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Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial

Sponsor
Rush University Medical Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04954625
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
37
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Autologous Blood Patch
  • Procedure: Standard of Care (per Physician)
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Autologous Blood Patch

Procedure: Autologous Blood Patch
All patients will be assessed on the morning of postoperative Day 3 and 4 for the presence of an air leak. If an air leak is present, 60-100 ml of autologous blood will be drawn from a peripheral vein and immediately instilled into the chest tube. The individual who draws blood is that the discretion of the site principal investigator. The tubing will be elevated over an IV pole while the patient remains in bed, moving position every 15 minutes for 1 hour to distribute the blood throughout the pleural cavity. The tubing support will then be removed, allowing the chest tube to drain. After ABP intervention, the chest tube will remain to water seal, as long as the patient tolerates it.
Active Comparator: Standard of Care (Per physician)

Procedure: Standard of Care (per Physician)
Patients randomized to Standard of Care will be treated as their surgeon would as routine. This may mean postoperative observation, of another type of intervention.

Outcome Measures

Primary Outcome Measures

  1. Prolonged Air Leak >5 days [Within 30 Days]

  2. Hospital Length of Stay [Within 30 Days]

  3. Readmission within 30 days [Within 30 Days]

  4. In hospital mortality [Within 30 Days]

  5. 30-day Mortality [Within 30 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who undergo pneumonectomy, sleeve lobectomy, chest wall or diaphragm resection, or bilateral procedures.

  • Age ≤ 18 years old

  • Women who are pregnant

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rush University Medical Center Chicago Illinois United States 60612

Sponsors and Collaborators

  • Rush University Medical Center

Investigators

  • Principal Investigator: Christopher Seder, MD, Rush University Medical Center
  • Study Director: Sebastien Gilbert, MD, University of Ottawa

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT04954625
Other Study ID Numbers:
  • 19072606
First Posted:
Jul 8, 2021
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rush University Medical Center
Surgery
Prolonged Air Leak
Autologous Blood Patch
Lung

Study Results

No Results Posted as of Jul 22, 2022