The overall objective of the study is investigate if it is possible to convert CV(+) patients to CV(-) patients with use of autologeous blood or alternatively blood derived products that closes the collateral channels. And thus to develop a…
ID
Bron
Verkorte titel
Aandoening
Chronic Obstructive Pulmonary Disease
Emphysema
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Feasibility: Evidence of targeted lung volume reduction (TLVR) on CT scan at 1 month Follow Up.
Achtergrond van het onderzoek
Title:
Study of proactive treatment of collateral ventilation in CV-positive emphysema patients before EBV treatment (MIND THE GAP)
Primary Objective:
1.To investigate the feasibility of injecting autologeous blood or blood derived products into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
Secondary Objectives:
2.To investigate the safety of injecting autologeous blood or blood derived products into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
3.To investigate the effectiveness of injecting autologeous blood or blood derived products into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
Study Design:
Prospective, single arm open label intervention study.
Study Population:
20 patients with heterogeneous emphysema and with 70-90% complete fissures detected on a CT scan.
Intervention:
The injection of autologeous blood or blood derived products into the interlobar collateral ventilation channels region to convert CV(+) lobes into CV(-) lobes.
Duration:
3 months follow-up, Study duration:24 months.
Primary endpoint:
Feasibility: Evidence of targeted lung volume reduction (TLVR) on CT scan at 1 month Follow Up.
Doel van het onderzoek
The overall objective of the study is investigate if it is possible to convert CV(+) patients to CV(-) patients with use of autologeous blood or alternatively blood derived products that closes the collateral channels. And thus to develop a bronchoscopic procedure for patients with heterogeneous emphysema who have collateral flow by combining the established EBV treatment with the injection of autologeous blood or blood derived products to close of the collateral channels.
Onderzoeksopzet
3 months follow-up after the procedure.
Onderzoeksproduct en/of interventie
The injection of autologeous blood or blood derived products into the interlobar collateral ventilation channels region to convert CV(+) lobes into CV(-) lobes.
Algemeen / deelnemers
University Medical Center Groningen<br>
PO Box 30001
D.J. Slebos
Groningen 9700 RB
The Netherlands
+31 (0)50 3612357
d.j.slebos@long.umcg.nl
Wetenschappers
University Medical Center Groningen<br>
PO Box 30001
D.J. Slebos
Groningen 9700 RB
The Netherlands
+31 (0)50 3612357
d.j.slebos@long.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1.Diagnosis of upper or lower lobe heterogeneous emphysema with a difference in heterogeneity of ¡Ý 25% in destruction at -950HU between ipsilateral lobes.
2.Subjects of both genders of at least 35 years of age at the time of the baseline visit.
3.Understand and voluntarily sign a patient informed consent form.
4.15 % predicted ¡Ü FEV1¡Ü 45% predicted.
5.RV >= 175% predicted, and TLC >= 100% predicted and RV/TLC >= 55% predicted.
6.6MWT >= 140 meters.
7.Dyspnea score of >= 2 on the mMRC scale of 0-4.
8.Non-smoker > 8 weeks prior to signing the informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1.Evidence of active pulmonary infection.
2.Evidence of clinically significant bronchiectasis.
3.History of more than 3 exacerbations with hospitalizations over the past 12 months.
4.Evidence of pulmonary hypertension (sPAP > 45mmHg).
5.Subject has DLCO <20% of predicted.
6.Myocardial infarction or other relevant cardiovascular events in the past 6 months.
7.Prior lung surgery, Lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy.
8.Prior endoscopic lung volume reduction.
9.Unstable pulmonary nodule requiring follow-up.
10.Pregnant or nursing women.
11.Hypercapnia defined by PaCO2 > 8.0kPa, or Hypoxemia defined by PaO2 < 6.0kPa, both measured on room air.
12.>20mg prednisolon (or equivalent) use/days.
13.Any disease with high probability of mortality within 24 months.
14.Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins).
15.Patient was involved in other pulmonary drug studies within 30 days prior to this study.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4905 |
| NTR-old | NTR5007 |
| CCMO | NL47731.042.14 |
| OMON | NL-OMON41669 |