Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-27 @ 5:45 PM
Study NCT ID:
NCT06937450
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2024-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traumatic Hemothorax Drainage and Daily Lavage: Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006491', 'term': 'Hemothorax'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004322', 'term': 'Drainage'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a single arm interventional pilot study comparing groups of trauma hemothorax-diagnosed patients. There will be 2 treatment groups and 2 historical control groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remaining Hemothorax Volume at 72 hours', 'timeFrame': '72 hours', 'description': 'Assessed by CT and Mergo Formula'}], 'secondaryOutcomes': [{'measure': 'Number of patients requiring intervention for retained hemothorax (excluding those who require intervention for other treatment)', 'timeFrame': 'Through hospital discharge or 30 days', 'description': 'All interventions focused on resolving any remaining hemothorax'}, {'measure': 'Patient Tolerability - Numerical Rating Scale (NRS) Perception Experience (IPE)', 'timeFrame': '1 hour, 24 hours, 48 hours', 'description': "Patient perception of the drainage and lavage procedure. Did this Drainage and Lavage procedure resolve, lessen or worsen the patient's symptoms?"}, {'measure': 'Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE)', 'timeFrame': '1 hour', 'description': "Patient perception of the chest tube insertion procedure.\n\n1. = It was okay, I can tolerate it, I can do it again.\n2. = It was okay, but I don't want to go through this again.\n3. = It was a bad experience for me.\n4. = It was a worse experience for me.\n5. = It was the worst experience of my life!"}, {'measure': 'Ease of CLR System Use - Industry-Standard System Usability Scale (SUS)', 'timeFrame': '1 hour, 24 hours, 48 hours', 'description': 'By physician who used the CLR Irrigator System. 5-point Likert scale from strongly disagree (low) to strongly agree (high).'}, {'measure': 'Chest Tube Placement Duration', 'timeFrame': 'Through discharge or 30 days', 'description': 'Length of time the chest tube remained in the patient'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Through discharge or 30 days', 'description': 'Length of hospital stay'}, {'measure': 'Aggregate Hospital Charges for Patient Stay', 'timeFrame': 'Through discharge or 30 days', 'description': 'Estimated cost of patient care at hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hemothorax; Traumatic']}, 'descriptionModule': {'briefSummary': 'This HTX treatment study evaluates the effects of chest tube size and the benefits of daily irrigations on acute HTX. 20 acutely injured but stable trauma patients requiring a chest tube for HTX will be enrolled. Patients will be assigned a 28Fr or 14 Fr chest tube with serial lavage and drainage. The endpoints will be HTX volume (by CT scan), complications, additional interventions, hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.', 'detailedDescription': 'This hemothorax (HTX) treatment study will evaluate the effects of chest tube size and daily lavage on HTX management outcomes. A total of 20 stable trauma patients requiring a chest tube for HTX will be recruited and consented. These patients will then undergo either 28Fr or 14Fr chest tube placement, depending on the preference of the treatment team at the time of placement. The study will include 10 patients with each type of chest tube (28Fr and 14Fr). Daily lavage will then be performed at 24h and 48h post-placement. Patients will be compared to historical control patients from the trauma registry who received either 28Fr or 14Fr chest tube placement followed by an initial lavage only. The primary endpoint will be the need for additional interventions such as tPA, additional chest tubes, thoracoscopic surgery (VATS), or thoracotomy. Secondary endpoints will include X-ray appearance at 72 hours, volume of HTX on CT at 72 hours, procedural complications, development of empyema (safety endpoint), development of delayed bleeding (safety endpoint), hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to provide consent for the research study\n2. More than 15 years of age\n3. Presence of acute traumatic HTX or HTX-PTX diagnosed on chest CT scan within 24 hours of injury and clinical indication for drainage (hemothorax of moderate or large size greater then 300 mL)\n4. Hemodynamic stability (heart rate 120 beats per minute; systolic blood pressure 90 mmHg)\n5. Bilateral or unilateral hemothorax of greater than 300 mL HTX by Mergo Formula from chest CT\n6. Able to complete the entire study including randomization, tube placement, lavages and final CT Scan.\n\nExclusion Criteria:\n\n1. Less than 15 years of Age\n2. Prisoner\n3. Pregnant due to the risk of CT scans\n4. HTX or HTX-PTX not requiring drainage or drainage performed prior to randomization/enrollment\n5. Patients undergoing operative intervention (i.e. thoracotomy) as initial management of hemothorax (6) Persistent hemodynamic instability after initial resuscitation and CT imaging'}, 'identificationModule': {'nctId': 'NCT06937450', 'acronym': 'HTXDLYLAVGE', 'briefTitle': 'Traumatic Hemothorax Drainage and Daily Lavage: Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Traumatic Hemothorax Treatment With 14-Fr Pigtail Catheters or Large Bore (~28Fr) Chest Tubes With Daily Irrigation: A Pilot Single-Arm Intervention Study', 'orgStudyIdInfo': {'id': '855480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage', 'description': 'Open Tube Thoracostomy with Daily Lavage and Drainage', 'interventionNames': ['Device: CLR Irrigator', 'Procedure: Serial Lavage and Drainage', 'Device: 28 Fr Open Chest Tube']}, {'type': 'EXPERIMENTAL', 'label': 'Percutaneous 14-Fr Catheter with Daily Lavage and Drainage', 'description': 'Percutaneous 14-Fr Catheter with Daily Lavage and Drainage', 'interventionNames': ['Device: CLR Irrigator', 'Procedure: Serial Lavage and Drainage', 'Device: Percutaneous 14Fr Chest Tube']}], 'interventions': [{'name': 'CLR Irrigator', 'type': 'DEVICE', 'description': 'All enrolled patients will have their hemothorax treated with a CLR device that allows for easy suction and irrigation through indwelling catheters,', 'armGroupLabels': ['Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage', 'Percutaneous 14-Fr Catheter with Daily Lavage and Drainage']}, {'name': 'Serial Lavage and Drainage', 'type': 'PROCEDURE', 'description': 'The current protocol is to do a singular lavage and drainage, this study will investigate the benefits of daily lavage.', 'armGroupLabels': ['Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage', 'Percutaneous 14-Fr Catheter with Daily Lavage and Drainage']}, {'name': '28 Fr Open Chest Tube', 'type': 'DEVICE', 'description': 'Patients will have a standard 28 Fr open chest tube or a percutaneous 14Fr chest tube placed.', 'armGroupLabels': ['Open 28 Fr Tube Thoracostomy with Daily Lavage and Drainage']}, {'name': 'Percutaneous 14Fr Chest Tube', 'type': 'DEVICE', 'description': 'Patients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed.', 'armGroupLabels': ['Percutaneous 14-Fr Catheter with Daily Lavage and Drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Penn Presbyterian Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Jeremy W Cannon, MD', 'role': 'CONTACT', 'email': 'jeremy.cannon@pennmedicine.upenn.edu', 'phone': '215-66-27320'}, {'name': 'Phillp Kemp Bohan, MD', 'role': 'CONTACT', 'email': 'Phillip.Kempbohn@Pennmedicine.upenn.edu', 'phone': '267-909-3573'}], 'overallOfficials': [{'name': 'Jeremy Cannon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share Individual Participant Data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'CLR Medical', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Trauma Program Medical Director and Section Chief of Trauma', 'investigatorFullName': 'Jeremy Cannon', 'investigatorAffiliation': 'University of Pennsylvania'}}}}