Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-14 @ 8:37 AM
Study NCT ID:
NCT03273894
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2017-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Management of Temperature in Children and Influence of Hypothermia on Blood Clotting in Children.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be tested for coagulation abnormalities - routine coagulation tests and ROTEM'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2017-09-04', 'studyFirstSubmitQcDate': '2017-09-04', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Influence of the hypothermia on the coagulation status', 'timeFrame': 'Perioperatively', 'description': 'Perioperative temperature management will be evaluated and the blood samples will be tested for possible coagulation abnormalities in patients undergoing surgery in general anesthesia'}], 'secondaryOutcomes': [{'measure': 'Temperature management', 'timeFrame': 'Perioperatively', 'description': 'Data will be evaluated and each perioperative temperature management method will be validated for the effectivity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypothermia, temperature management'], 'conditions': ['Perioperative Hypothermia']}, 'referencesModule': {'references': [{'pmid': '40589964', 'type': 'DERIVED', 'citation': 'Trckova A, Bonischova T, Zelinkova H, Stourac P. Perioperative temperature management and coagulation: effects of mild hypothermia in a prospective study. Front Med (Lausanne). 2025 Jun 16;12:1536782. doi: 10.3389/fmed.2025.1536782. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'Perioperative hypothermia carries high risk of associated complications. In the observational study, the standard perioperative temperature management will be evaluated and the influence of the hypothermia on the coagulation system according to routine coagulation testing in combination with ROTEM will be evaluated.', 'detailedDescription': "Perioperative hypothermia is one of the complications of surgical interventions in total or regional anaesthesia. It is defined as a drop in body core temperature under 36°C. It occurs as a result of combination of anaesthesia, effecting of central thermoregulation control, environment temperature (i.e. operating theatre) and unsufficient isolation combined with patient's unability to actively warm up. As the body temperature drop in patients under anaesthesia is very frequent, body temperature checks became part of surgical patients care optimalisation. Furthermore, it is associated with complications, such as higher incidency of surgical wound infection, elongated healing process, longer time spent in a hospital, cardiac complications, elongated effect of most of anaesthetics, immunity and blood clotting disorders. Hypothermia elongates the initial phase of coagulation and results in thrombocytes malfunction. Normothermia reduces blood loss.\n\nThis prospective observative study has two parts. In the first one, investigators will evaluate the perioperative management of temperature in paediatric patients in Department of children anaesthesia and intensive care, University hospital Brno, Czech republic, where is intended to involve 1,000 patients. In the second phase, the patients who, based on the first phase of the study, would be the most prone to perioperative hypothermia, will be examined for any change of coagulation parameters related to the hypothermia. Investigators intend to involve 100 consecutive patients of the original group. The examined parameters are standard coagulation tests, EXTEM, FIBTEM tests obtained from a rotational thromboelastometry, or other ROTEM test related to the particular pathology. Investigators will use a standardized method of fluid management to affect dilutional coagulopathy.\n\nStandard perioperative patient's monitoring - temperature sensor monitoring of body temperature, ECG, noninvasive blood pressure, oxygen saturation, EtCO2\n\nTemperature management:\n\n\\- the anaesthetist decides if some warming tools are needed and notes the used ones, which involve: warmed infusion, heating blanked, air warming system, infusion pipe heater, increasing of temperature in the operating theatre, covering the patient or another method of temperature management\n\nMonitored parameters in the first phase:\n\n* body temperature before the intervention (measured in the office previously), operating theatre's temperature at the beginning of anaesthesia\n* body temperature during the intervention including the way of measuring, marked each 15 minutes\n* body temperature at the end of the entire intervention, including signs of the patient's heat discomfort\n* body temperature during resting time in the after-surgery resting room\n\nMonitored parameters in the second phase:\n\n* monitored parameters in the first phase + following:\n* blood sampling for standard coagulation tests (following initial of general anaesthesia) + EXTEM, FIBTEM. In case of any pathology found here, more relevant test are run. The test is analysed by anaesthetist or ICU doctor, where the ROTEM machine is.\n* blood sampling for standard coagulation tests (prior to the end of the surgical intervention) + EXTEM, FIBTEM. In case of any pathology found here, more relevant test are run. The test is analysed by anaesthetist or ICU doctor, where the ROTEM machine is.\n* if body temperature is below 34°C, two sets of ROTEM tests are run: one at patient's body temperature, following by another one at a standard temperature (37°C).\n\nStatistic evaluation:\n\n* demographic - age, sex, type of surgery, duration of surgery, type of anaesthesia\n* changes of core temperature during the perioperative care and influence of used warming tools, side effects of changes of core temperature\n* laboratory tests - standard coagulation tests and ROTEM - EXTEM, FIBTEM test"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Paediatric patients undergoing surgery in general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* paediatric patients of age 0 - 18 years (+ 364 days) indicated to a surgical intervention with expected duration longer than 30 minutes\n* informed consent of the patient's legal representative to blood sampling in order to run the coagulation tests\n\nExclusion Criteria:\n\n* surgical intervention shorter than 20 minutes for the second phase:\n* disagreement of the patient and their legal representative\n* preexisting blood clotting disorder\n* potential damage on the patient caused by non-indicated blood sampling (newborns with low, very low or extremely low birth weight)"}, 'identificationModule': {'nctId': 'NCT03273894', 'acronym': 'Peritemp', 'briefTitle': 'Perioperative Management of Temperature in Children and Influence of Hypothermia on Blood Clotting in Children.', 'organization': {'class': 'OTHER', 'fullName': 'Brno University Hospital'}, 'officialTitle': 'Perioperative Management of Temperature in Children and Influence of Hypothermia on Blood Clotting in Children.', 'orgStudyIdInfo': {'id': 'Temperature KDAR 2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paediatric patients undergoing surgery in general anesthesia', 'description': 'Paediatric patients undergoing surgery in general anesthesia with the expected duration over 30 minutes', 'interventionNames': ['Diagnostic Test: Coagulation testing']}], 'interventions': [{'name': 'Coagulation testing', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Coagulation status'], 'description': "* body temperature before the intervention\n* body temperature during the intervention including the way of measuring, each 15 minutes\n* body temperature at the end of surgery, signs of the patient's heat discomfort\n* body temperature during resting time in the postanesthesia care\n* standard coagulation tests + EXTEM, FIBTEM - after anesthesia induction\n* blood sampling for standard coagulation tests (prior to the end of the surgical intervention) + EXTEM, FIBTEM.\n* if body temperature is below 34°C, two sets of ROTEM tests are run: one at patient's body temperature, following by another one at a standard temperature (37°C).", 'armGroupLabels': ['Paediatric patients undergoing surgery in general anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62500', 'city': 'Brno', 'state': 'Jihomoravská Kraj', 'country': 'Czechia', 'facility': 'University hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'overallOfficials': [{'name': 'Petr Štourač, prof.MD.Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Brno University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brno University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doc.MD.Ph.D', 'investigatorFullName': 'Petr Štourač, MD', 'investigatorAffiliation': 'Brno University Hospital'}}}}