Perioperative HypothermiaPeritempNCT03273894
Perioperative Management of Temperature in Children and Influence of Hypothermia on Blood Clotting in Children.
An observational study of Perioperative Hypothermia, run by Brno University Hospital at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Perioperative Hypothermia
- What is being tested?
- Coagulation testing
- How many people
- 102 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2017to 24 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Paediatric patients undergoing surgery in general anesthesia
Who may be able to join
- paediatric patients of age 0 - 18 years (+ 364 days) indicated to a surgical intervention with expected duration longer than 30 minutes
- informed consent of the patient's legal representative to blood sampling in order to run the coagulation tests
Who cannot join
- surgical intervention shorter than 20 minutes for the second phase:
- disagreement of the patient and their legal representative
- preexisting blood clotting disorder
- potential damage on the patient caused by non-indicated blood sampling (newborns with low, very low or extremely low birth weight)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
This 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.
Standard perioperative patient's monitoring - temperature sensor monitoring of body temperature, ECG, noninvasive blood pressure, oxygen saturation, EtCO2
Temperature management:
- 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
Monitored parameters in the first phase:
- body temperature before the intervention (measured in the office previously), operating theatre's temperature at the beginning of anaesthesia
- body temperature during the intervention including the way of measuring, marked each 15 minutes
- body temperature at the end of the entire intervention, including signs of the patient's heat discomfort
- body temperature during resting time in the after-surgery resting room
Monitored parameters in the second phase:
- monitored parameters in the first phase + following:
- 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.
- 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.
- 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).
Statistic evaluation:
- demographic - age, sex, type of surgery, duration of surgery, type of anaesthesia
- changes of core temperature during the perioperative care and influence of used warming tools, side effects of changes of core temperature
- laboratory tests - standard coagulation tests and ROTEM - EXTEM, FIBTEM test
- Conditions
- Perioperative Hypothermia
- Being tested
- Coagulation testing
- Keywords
- Hypothermia, temperature management
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coagulation testingDiagnostic test
Also called Coagulation status
- body temperature before the intervention
- body temperature during the intervention including the way of measuring, each 15 minutes
- body temperature at the end of surgery, signs of the patient's heat discomfort
- body temperature during resting time in the postanesthesia care
- standard coagulation tests + EXTEM, FIBTEM - after anesthesia induction
- blood sampling for standard coagulation tests (prior to the end of the surgical intervention) + EXTEM, FIBTEM.
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Paediatric patients undergoing surgery in general anesthesia | Paediatric patients undergoing surgery in general anesthesia with the expected duration over 30 minutes Receives: Diagnostic Test: Coagulation testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of the hypothermia on the coagulation status
Perioperative temperature management will be evaluated and the blood samples will be tested for possible coagulation abnormalities in patients undergoing surgery in general anesthesia
Measured: Perioperatively
Secondary outcomes (1)
Temperature management
Data will be evaluated and each perioperative temperature management method will be validated for the effectivity
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 May 2017
- Primary completion27 Aug 2021
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, prof.MD.Ph.D, Study chair, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273894
- Sponsor's protocol ID
- Temperature KDAR 2017
- Acronym
- Peritemp
- Status last verified
- Feb 2023
- First submitted
- 4 Sep 2017
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40589964
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Management of Temperature in Children and Influence of Hypothermia on Blood Clotting in Children.
- ClinicalTrials.gov ID
- NCT03273894
- Acronym / sponsor ID
- Peritemp / Temperature KDAR 2017
- Conditions
- Perioperative Hypothermia
- Keywords
- Hypothermia, temperature management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
This 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.
Standard perioperative patient's monitoring - temperature sensor monitoring of body temperature, ECG, noninvasive blood pressure, oxygen saturation, EtCO2
Temperature management:
- 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
Monitored parameters in the first phase:
- body temperature before the intervention (measured in the office previously), operating theatre's temperature at the beginning of anaesthesia
- body temperature during the intervention including the way of measuring, marked each 15 minutes
- body temperature at the end of the entire intervention, including signs of the patient's heat discomfort
- body temperature during resting time in the after-surgery resting room
Monitored parameters in the second phase:
- monitored parameters in the first phase + following:
- 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.
- 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.
- 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).
Statistic evaluation:
- demographic - age, sex, type of surgery, duration of surgery, type of anaesthesia
- changes of core temperature during the perioperative care and influence of used warming tools, side effects of changes of core temperature
- laboratory tests - standard coagulation tests and ROTEM - EXTEM, FIBTEM test
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paediatric patients undergoing surgery in general anesthesia | – | Diagnostic Test: Coagulation testingPaediatric patients undergoing surgery in general anesthesia with the expected duration over 30 minutes |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Paediatric patients undergoing surgery in general anesthesia
Key inclusion criteria (2 listed)
- paediatric patients of age 0 - 18 years (+ 364 days) indicated to a surgical intervention with expected duration longer than 30 minutes
- informed consent of the patient's legal representative to blood sampling in order to run the coagulation tests
Key exclusion criteria (4 listed)
- surgical intervention shorter than 20 minutes for the second phase:
- disagreement of the patient and their legal representative
- preexisting blood clotting disorder
- potential damage on the patient caused by non-indicated blood sampling (newborns with low, very low or extremely low birth weight)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coagulation testingAlso: Coagulation status* body temperature before the intervention * body temperature during the intervention including the way of measuring, each 15 minutes * body temperature at the end of surgery, signs of the patient's heat discomfort * body temperature during resting time in the postanesthesia care * standard coagulation tests + EXTEM, FIBTEM - after anesthesia induction * blood sampling for standard coagulation tests (prior to the end of the surgical intervention) + EXTEM, FIBTEM. * 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). | Diagnostic test | Paediatric patients undergoing surgery in general anesthesia |
Primary outcome
Influence of the hypothermia on the coagulation status
Time frame: Perioperatively
Perioperative temperature management will be evaluated and the blood samples will be tested for possible coagulation abnormalities in patients undergoing surgery in general anesthesia
1 secondary outcome
Temperature management
Time frame: Perioperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 40589964Trckova 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Štourač, prof.MD.Ph.D study chair
Brno University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Hypothermia, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of the hypothermia on the coagulation status (time frame: Perioperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03273894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.