Perioperative Management of Temperature in Children and Influence of Hypothermia on Blood Clotting in Children.

NCT03273894 | Completed DMC

• 1 other identifier: Temperature KDAR 2017
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perioperative Hypothermia

Keywords

Hypothermia, temperature management

Outcome Measures

Primary Outcomes (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

  Perioperatively

Secondary Outcomes (1)

• Temperature management

  Perioperatively

Study Arms (1)

Paediatric patients undergoing surgery in general anesthesia

Paediatric patients undergoing surgery in general anesthesia with the expected duration over 30 minutes

Diagnostic Test: Coagulation testing

Interventions

Coagulation testing DIAGNOSTIC_TEST

* 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).

Also known as: Coagulation status

Paediatric patients undergoing surgery in general anesthesia

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Paediatric patients undergoing surgery in general anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University hospital Brno

Brno, Jihomoravská Kraj, 62500, Czechia

Location

Related Publications (1)

• 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.

  PMID: 40589964 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be tested for coagulation abnormalities - routine coagulation tests and ROTEM

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Petr Štourač, prof.MD.Ph.D

  Brno University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doc.MD.Ph.D

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 6, 2017
• Study Start: May 1, 2017
• Primary Completion: August 27, 2021
• Study Completion: February 24, 2023
• Last Updated: November 21, 2024

Record last verified: 2023-02

Locations

CZ (1)