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Procedure

Arm 1: First Occurrence for Primary Spontaneous Pneumothorax

N/A

Recruiting

Led By Brian Gulack, MD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with primary spontaneous pneumothorax (first occurrence) and meets criteria for chest tube placement or Diagnosed with recurrent primary spontaneous pneumothorax (recurrence) and meets criteria for blebectomy with a pleural procedure

Between the ages of 13-18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial showed that using a patient's own blood to close holes in the lungs can reduce the risk of prolonged air leaks and reduce hospital stay for those with Primary Spontaneous Pneumothorax.

Who is the study for?

This trial is for young individuals aged 13-18 who have had a collapsed lung (primary spontaneous pneumothorax) for the first time and need a chest tube, or those with recurrent lung collapse needing surgery to remove blisters on the lungs along with another procedure on the pleural space.Check my eligibility

What is being tested?

The study tests if using an autologous blood patch—a procedure that uses a patient's own blood to seal holes in their lungs—can reduce prolonged air leaks and shorten hospital stays after treating a collapsed lung.See study design

What are the potential side effects?

Possible side effects of an autologous blood patch may include discomfort at the injection site, risk of infection, allergic reactions, or failure to resolve the air leak leading to further medical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a collapsed lung for the first time or again and need specific treatments.

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I am between 13 and 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hospital Length of Stay

Secondary outcome measures

Incidence of Prolonged Air Leak (>48 hours)

Procedural Pain score

Other outcome measures

Incidence of Infectious Complications

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: RecurrenceExperimental Treatment1 Intervention

All patients who meet criteria and provide informed consent will be treated per institutional protocols with a thoracoscopic blebectomy and mechanical pleurodesis or pleurectomy. At the conclusion of the procedure, 2 ml/kg of whole blood (max 100 ml) obtained via venipuncture will be injected into the pleural space. The chest tube will be left clamped for 180 minutes post-procedure and then placed back to suction. During this period of clamping, the patient will be rotated from side to side intermittently to help the blood move around the extrapleural space.

Group II: Arm 1: First OccurrenceExperimental Treatment1 Intervention

All patients who meet criteria and consent to involvement will be treated per institutional protocols with a tube thoracostomy. Chest tube size will be determined by the physician of record. Once the chest tube is placed, it will be placed to suction for a minimum of two minutes to allow for lung re-expansion while 2 ml/kg of whole blood (max 100 ml) is obtained via venipuncture (preferably a previously established intravenous catheter). This blood will then be injected via the chest tube which will then be clamped for 180 minutes, before being returned to suction. During this period of clamping, the patient will be rotated from side to side intermittently to help the blood move around the extrapleural space.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,481 Total Patients Enrolled

Brian Gulack, MDPrincipal InvestigatorRush University Medical Center

1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total patient count of this clinical trial?

"Indeed, according to clinicaltrials.gov this medical trial is accepting participants. It was initially posted on the 1st of January 2024 and edited as recently as the 15th December 2023 with a total of 20 patients needed from one site."

Answered by AI

Is the age limitation for this clinical trial above 35 years?

"This trial has a cut-off age of 18 and will only accept participants that are at least 13 years old."

Answered by AI

To which demographic does enrollment in this experiment extend?

"This research requires the enrolment of 20 adolescents (age range 13-18) suffering from primary spontaneous pneumothorax. To qualify, patients must meet one or more of these conditions: aged between 13 and 18 with an initial occurrence that necessitates chest tube placement; recurrent cases where pleural ablation is necessary via blebectomy."

Answered by AI

Are there any available slots to participate in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this trial is still open for enrollment and was initially advertised on January 1st 2024. It has since been revised as recently as December 15th 2023 with a total of 20 patients being sought from one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autologous Blood Patch for Primary Spontaneous Pneumothorax

Brian Gulack 2024. "Autologous Blood Patch for Primary Spontaneous Pneumothorax". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06088901.