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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Czechia1 site
  • University hospital Brno

    Brno, Jihomoravská Kraj, 62500

Other trials in Czechia

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
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 groups in NCT03273894
Study groupRoleWhat they receive
Paediatric patients undergoing surgery in general anesthesiaPaediatric 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.

  1. 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)
  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.

  1. First posted6 Sep 2017
  2. Study start1 May 2017
  3. Primary completion27 Aug 2021
  4. Study completion24 Feb 2023

Resources

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)
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

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.

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