Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-28 @ 12:47 PM
Study NCT ID:
NCT03791333
Status:
UNKNOWN
Last Update Posted:
2019-01-02
First Post:
2018-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-center Clinical Study on the Status of Trauma Evaluating Ability in Patients With Multiple Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009104', 'term': 'Multiple Trauma'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015601', 'term': 'Injury Severity Score'}], 'ancestors': [{'id': 'D015599', 'term': 'Trauma Severity Indices'}, {'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-31', 'studyFirstSubmitDate': '2018-12-31', 'studyFirstSubmitQcDate': '2018-12-31', 'lastUpdatePostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ISS score of third-level surgeons for the same patient', 'timeFrame': '3 years', 'description': 'ISS score of third-level surgeons for the same patient'}, {'measure': 'Scoring time', 'timeFrame': '3 years', 'description': 'Scoring spending time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Trauma/Injuries']}, 'referencesModule': {'references': [{'pmid': '5565650', 'type': 'BACKGROUND', 'citation': 'Kirkpatrick JR, Youmans RL. Trauma index. An aide in the evaluation of injury victims. J Trauma. 1971 Aug;11(8):711-4. No abstract available.'}, {'pmid': '3946860', 'type': 'BACKGROUND', 'citation': 'Koehler JJ, Baer LJ, Malafa SA, Meindertsma MS, Navitskas NR, Huizenga JE. Prehospital Index: a scoring system for field triage of trauma victims. Ann Emerg Med. 1986 Feb;15(2):178-82. doi: 10.1016/s0196-0644(86)80016-6.'}, {'type': 'BACKGROUND', 'citation': 'Jennett B. The Glasgow Coma Scale: History and current practice. Trauma, 2002, 4(2):91-103.'}, {'pmid': '4814394', 'type': 'BACKGROUND', 'citation': "Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. No abstract available."}]}, 'descriptionModule': {'briefSummary': 'Trauma is a major medical and public health problem facing all countries in the world today. Trauma is the leading cause of death worldwide for people under 45 years of age, and more than 5 million people die each year from severe trauma. According to the "China Injury Prevention Report" issued by the Ministry of Health in August 2007, about 200 million injuries occur annually in China, with 700,000 to 750,000 deaths, accounting for about 9% of the total number of deaths. Serious trauma has the characteristics of high mortality and disability rate, and often affects the main groups of young and middle-aged people of social labor force. It has a tremendous impact on social and economic development, and has brought a heavy burden to society and families. The treatment of severe trauma is extremely important, and its treatment process needs a standardized model. In many links of trauma treatment, accurate assessment of injury is the precondition of classification and grading of diagnosis and treatment, and also provides a good basis for the follow-up standardized treatment of patients. The accuracy and consistency of injury assessment are also the reflection of diagnosis and treatment ability. ISS score is an evaluation method for severe trauma and multiple trauma patients. It has been used by emergency personnel for a long time. It also plays a very good auxiliary role in the evaluation and treatment of patients\'injuries. However, there are still many problems in the clinical use of ISS scores: 1. Some hospitals do not attach importance to the application of ISS scores, and do not fully understand the scoring method; 2. Low frequency of use, inaccurate grasp of the method; 3. Three-level physicians have different valuations of ISS scores for the same kind of trauma; 4. Use AIS scoring table to calculate. It takes a long time to calculate the ISS score, which affects the normal first aid efficiency. To this end, our research team designed a questionnaire on the use of ISS score. The main purpose of the questionnaire is to assess and register the severity of injury in multiple trauma patients to understand the current use and proficiency of ISS score system by Chinese trauma surgeons, the difference of ISS score between three-level doctors and the same patient, and ISS score. The consistency between the software and AIS scoring table and the scoring time of the two methods are also discussed. This study hopes that through this survey, we can understand the current situation of the application of the scoring system in Chinese hospitals, in order to promote the standardization of severe trauma assessment and promote the use of the evaluation system in hospitals throughout the country, so as to provide optimized trauma treatment process for trauma patients.', 'detailedDescription': '1. Research Background and Basis for Project Establishment\\* Trauma is a major medical and public health problem facing all countries in the world today. Trauma is the leading cause of death worldwide for people under 45 years of age, and more than 5 million people die each year from severe trauma. According to the "China Injury Prevention Report" issued by the Ministry of Health in August 2007, about 200 million injuries occur annually in China, with 700,000 to 750,000 deaths, accounting for about 9% of the total number of deaths. Serious trauma has the characteristics of high mortality and disability rate, and often affects the main groups of young and middle-aged people of social labor force. It has a tremendous impact on social and economic development, and has brought a heavy burden to society and families. The treatment of severe trauma is extremely important, and its treatment process needs a standardized model. In many links of trauma treatment, accurate assessment of injury is the precondition of classification and grading of diagnosis and treatment, and also provides a good basis for the follow-up standardized treatment of patients. The accuracy and consistency of injury assessment are also the reflection of diagnosis and treatment ability. ISS score is an evaluation method for severe trauma and multiple trauma patients. It has been used by emergency personnel for a long time. It also plays a very good auxiliary role in the evaluation and treatment of patients\'injuries. However, there are still many problems in the assessment of severe trauma in various parts of China. It is difficult to adapt to the needs of the current medical and health system reform and to meet the needs of the society for the assessment of severe trauma. In the clinical use of ISS scoring, the main problems are as follows: 1. Some hospitals do not attach importance to the application of ISS scoring, and do not fully understand the scoring method; 2. The use of low frequency, inaccurate grasp of the method; 3. Three-level physicians have different evaluation of ISS scoring for the same kind of trauma; 4. Applying AIS scoring table to calculate ISS scoring. It takes a long time to share the time, which affects the normal first aid efficiency.\n2. Research purposes \\* By assessing and registering the severity of multiple trauma patients, we can understand and improve the ability of different hospitals and doctors at different levels in different regions to assess the severity of multiple trauma patients, and promote the use of ISS scoring system in national trauma centers. In order to improve the level of understanding of multiple trauma patients and lay a foundation for the establishment of scientific classification and sorting and treatment system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with multiple injuries who visited our research centers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Age not less than 18 years old; 2. Multiple trauma patients; 3. Complete auxiliary examination data of various trauma sites.\n\nExclusion Criteria:\n\n* Patients who died on the spot or came to hospital; pregnant and lying-in women.'}, 'identificationModule': {'nctId': 'NCT03791333', 'briefTitle': 'A Multi-center Clinical Study on the Status of Trauma Evaluating Ability in Patients With Multiple Trauma', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Multi-center Clinical Study on the Status of Trauma Evaluating Ability in Patients With Multiple Trauma', 'orgStudyIdInfo': {'id': 'PUPH20181127'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'multi trauma patients group', 'interventionNames': ['Other: injury severity score']}], 'interventions': [{'name': 'injury severity score', 'type': 'OTHER', 'description': 'injury severity score of multi trauma patients', 'armGroupLabels': ['multi trauma patients group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Peng ZHANG, Doctor', 'role': 'CONTACT', 'email': 'hcooh2001@163.com', 'phone': '13001061778'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'department of orthopaedic and trauma', 'investigatorFullName': 'wang tianbing', 'investigatorAffiliation': "Peking University People's Hospital"}}}}