NCT02352012

Brief Summary

The purpose of this study is to determine whether injecting autologous blood or putting bronchial plug through bronchoscope is effective in the treatment of refractory pneumothorax.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
269

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

November 18, 2014

Last Update Submit

January 4, 2016

Conditions

Pneumothorax

Keywords

Interventional TreatmentRefractory PneumothoraxBronchoscope

Outcome Measures

Primary Outcomes (1)

  • Duration of air leakage

    up to two weeks

Secondary Outcomes (1)

  • duration of pulmonary atelectasis

    up to two weeks

Other Outcomes (4)

  • Arterial blood gas

    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • complications

    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • hospital costs

    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • +1 more other outcomes

Study Arms (3)

Autologous blood group A

EXPERIMENTAL

Autologous blood was perfused to the target pulmonary segment

Other: Autologous blood

Bronchial plug group B

EXPERIMENTAL

Bronchial plug was placed to the target pulmonary segment

Device: Bronchial plug

control group

NO INTERVENTION

Control group was given to continuous negative pressure drainage

Interventions

Autologous bloodOTHER

Autologous blood was perfused to the target pulmonary segment

Autologous blood group A
Bronchial plugDEVICE

Bronchial plug was placed to the target pulmonary segment

Bronchial plug group B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spontaneous pneumothorax has been treating with thoracic closed drainage for 7 days, the patient has still persistent air leakage;
  • Patients informed consent to participate in this study and can complete the requirements of the follow-up visit

You may not qualify if:

  • Patients with severe abnormal gas exchange are defined as PaCO2\>50mmHg(6.6kPa) or PaO2\<45mmHg(6.0kPa) ;
  • Patients have systemic disease or cancer which affect the survival time ;
  • Patients have other serious diseases (the researchers think patient is not an appropriate candidate) which affect the evaluation or follow-up in research;
  • Patients are not suitable for or unable to tolerate bronchoscopy procedures;
  • Patients have active tuberculosis;
  • Patients have any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints including interference test of nerves or skeletal muscle disease;
  • Patients have demonstrated unwillingness or inability to complete screening or baseline data collection procedures;
  • Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study;
  • Female patient of childbearing potential has a positive result from a pregnancy test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Related Publications (8)

  • Gilbert CR, Toth JW, Osman U, Reed MF. Endobronchial valve placement as destination therapy for recurrent pneumothorax in the setting of advanced malignancy. Respir Care. 2015 Mar;60(3):e46-8. doi: 10.4187/respcare.03540. Epub 2014 Oct 21.

    PMID: 25336533BACKGROUND

  • Cundiff WB, McCormack FX, Wikenheiser-Brokamp K, Starnes S, Kotloff R, Benzaquen S. Successful management of a chronic, refractory bronchopleural fistula with endobronchial valves followed by talc pleurodesis. Am J Respir Crit Care Med. 2014 Feb 15;189(4):490-1. doi: 10.1164/rccm.201311-1965LE. No abstract available.

    PMID: 24528320BACKGROUND

  • Yamashita T, Urabe N. [Prolonged iatrogenic pneumothorax with refractory hepatic hydrothorax treated successfully with local anesthetic thoracoscopic talc poudrage]. Kyobu Geka. 2013 Jun;66(6):460-3. Japanese.

    PMID: 23917049BACKGROUND

  • Odaka M, Akiba T, Mori S, Asano H, Yamashita M, Kamiya N, Morikawa T. Thoracoscopic surgery for refractory cases of secondary spontaneous pneumothorax. Asian J Endosc Surg. 2013 May;6(2):104-9. doi: 10.1111/j.1758-5910.2012.00161.x. Epub 2012 Oct 29.

    PMID: 23107020BACKGROUND

  • Iyama S, Sato T, Murase K, Kikuchi S, Kamihara Y, Ono K, Takada K, Miyanishi K, Sato Y, Takimoto R, Kobune M, Obama T, Miyajima M, Watanabe A, Higami T, Hirayama Y, Kato J. Successful treatment by fibrin glue sealant for pneumothorax with chronic GVHD resistant to autologous blood patch pleurodesis. Intern Med. 2012;51(15):2011-4. doi: 10.2169/internalmedicine.51.7355. Epub 2012 Aug 1.

    PMID: 22864128BACKGROUND

  • Lin XM, Liu Y, Chi C, Lin CX, Yang Y. Efficacy of an absorbable polyglycolic acid patch in surgery for pneumothorax due to silicosis. J Cardiothorac Surg. 2012 Mar 6;7:18. doi: 10.1186/1749-8090-7-18.

    PMID: 22394587BACKGROUND

  • Lin XM, Lin CX, Chi C. [Application of absorbable Neoveil patch in operation on refractory pneumothorax in silicosis patients]. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2010 Jan;28(1):60-1. No abstract available. Chinese.

    PMID: 20426989BACKGROUND

  • Bialas RC, Weiner TM, Phillips JD. Video-assisted thoracic surgery for primary spontaneous pneumothorax in children: is there an optimal technique? J Pediatr Surg. 2008 Dec;43(12):2151-5. doi: 10.1016/j.jpedsurg.2008.08.041.

    PMID: 19040924BACKGROUND

Related Links

MeSH Terms

Conditions

Pneumothorax

Interventions

Blood Transfusion, Autologous

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeutics

Study Officials

  • Faguang Jin, MD & PhD

    Tang-Du Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wangping Li, MD

CONTACT

8618066620066; 8629-778526qxd25@163.com

Yun Li, MD

CONTACT

8618629675387littleyun@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

January 30, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2015

Study Completion

June 1, 2017

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

CN(1)