Coagulation Defect; BleedingNCT03699813
ROTEM Versus aPTT/PT in Pediatric Surgery
An observational study of Coagulation Defect; Bleeding, run by University Hospital, Motol.
Trial summary
Hemocoagulation management in perioperative bleeding is nowadays based on standard coagulation testing: activated partial thromboplastin time (aPTT), prothrombin time (PT), fibrinogen, D-dimers, platelets. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Coagulation Defect; Bleeding
- What is being tested?
- Comparison of two approaches to bleeding management
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2015to 15 Sep 2018
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients who underwent surgical scoliosis correction
Who may be able to join
- pediatric patients after surgical correction of scoliosis
Who cannot join
- patients older than 18 years
About this study
Official title: Use of Rotational Thromboelastometry (ROTEM) in Pediatric Perioperative Medicine and Its Comparison With Standard Coagulation Tests aPTT/PT
Hemocoagulation management in perioperative bleeding is nowadays based on standard coagulation testing: activated partial thromboplastin time (aPTT), prothrombin time (PT), fibrinogen, D-dimers, platelets. An interest about viscoelastic coagulation testing methods is rising - use of rotational thromboelastometry (ROTEM) is mentioned in the newest European guidelines for hemostasis management. ROTEM has more advantages then standard tests. However, both tests have only grade 1C recommendation, and most of trials have been done on adults. The goal of the study is to compare a relationship between standard tests and ROTEM in pediatric patients in perioperative period to find out which test has better correlation with clinical status, to compare therapeutic strategies and time necessary for gain both of tests and to compare the difference in blood loss and blood products consumption in group treated by ROTEM versus standard tests. Reduced blood loss and amount of blood products transfusion is expected to be found in ROTEM group, representing lowering risk for the patient, all due to early evaluation of hemocoagulation and targeted therapy guided by ROTEM.
Read the detailed description
Pediatric patients who underwent spine surgery (under 18 years old) will be recruited in our study.
Retrospective data will be analysed from these patient who underwent scoliosis surgery before ROTEM implementation to daily practice and after ROTEM implementation do daily practice in our department.
Time to available results of ROTEM versus aPTT/PT tests will be compared. Blood loss and blood products used in these both groups will be analysed and compared between 2 groups.
- Conditions
- Coagulation Defect; Bleeding
- Being tested
- Comparison of two approaches to bleeding management
- Keywords
- ROTEM, PT, aPTT
- Medical subject headings
- Hemostatic Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of two approaches to bleeding managementOther
| Study group | Role | What they receive |
|---|---|---|
| scoliosis bleeding management based on aPTT/PT | Bleeding and coagulopathy during surgery managed by clinical approach and aPTT/PT tests.
Blood loss, consumption of fresh frozen plasma (FFP), red blood cell units consumption and time to aPTT/PT tests result will be analysed. Receives: Other: Comparison of two approaches to bleeding management | |
| scoliosis bleeding management based on ROTEM | Bleeding and coagulopathy during surgery managed by ROTEM. Blood loss, consumption of fresh frozen plasma (FFP), red blood cell units consumption and time to aPTT/PT tests result will be analysed. Receives: Other: Comparison of two approaches to bleeding management |
What is being measured
The primary outcome is the main question the study is designed to answer.
analysing blood loss during surgery
blood loss during scoliosis surgery will analysed in both groups
Measured: 3 years
Secondary outcomes (2)
analysing blood transfusion units consumption
consumption of blood transfusion products will be analysed in both groups
Measured: 3 years
time to results of tests
time to available results of test ROTEM and aPTT/PT will be analysed and compared between both groups
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start2 Feb 2015
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
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 Coagulation Defect; BleedingStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Durila Miroslav MUDr. Ph.D., University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699813
- Sponsor's protocol ID
- 05102018
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data of study will be available in published paper
Publications
Jonas J, Durila M, Malosek M, Maresova D, Stulik J, Barna M, Vymazal T. Usefulness of perioperative rotational thrombelastometry during scoliosis surgery in children. J Neurosurg Spine. 2020 Jan 24;32(6):865-870. doi: 10.3171/2019.11.SPINE191137. Print 2020 Jun 1.
PubMed 31978886
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Rotational Thromboelastometry (ROTEM) in Pediatric Perioperative Medicine and Its Comparison With Standard Coagulation Tests aPTT/PT
- ClinicalTrials.gov ID
- NCT03699813
- Acronym / sponsor ID
- 05102018
- Conditions
- Coagulation Defect; Bleeding
- Keywords
- ROTEM, PT, aPTT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 9 Oct 2018 (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.
Hemocoagulation management in perioperative bleeding is nowadays based on standard coagulation testing: activated partial thromboplastin time (aPTT), prothrombin time (PT), fibrinogen, D-dimers, platelets. An interest about viscoelastic coagulation testing methods is rising - use of rotational thromboelastometry (ROTEM) is mentioned in the newest European guidelines for hemostasis management. ROTEM has more advantages then standard tests. However, both tests have only grade 1C recommendation, and most of trials have been done on adults. The goal of the study is to compare a relationship between standard tests and ROTEM in pediatric patients in perioperative period to find out which test has better correlation with clinical status, to compare therapeutic strategies and time necessary for gain both of tests and to compare the difference in blood loss and blood products consumption in group treated by ROTEM versus standard tests. Reduced blood loss and amount of blood products transfusion is expected to be found in ROTEM group, representing lowering risk for the patient, all due to early evaluation of hemocoagulation and targeted therapy guided by ROTEM.
Detailed description
Pediatric patients who underwent spine surgery (under 18 years old) will be recruited in our study.
Retrospective data will be analysed from these patient who underwent scoliosis surgery before ROTEM implementation to daily practice and after ROTEM implementation do daily practice in our department.
Time to available results of ROTEM versus aPTT/PT tests will be compared. Blood loss and blood products used in these both groups will be analysed and compared between 2 groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scoliosis bleeding management based on aPTT/PT | – | Other: Comparison of two approaches to bleeding managementBleeding and coagulopathy during surgery managed by clinical approach and aPTT/PT tests. Blood loss, consumption of fresh frozen plasma (FFP), red blood cell units consumption and time to aPTT/PT tests result will be analysed. |
| scoliosis bleeding management based on ROTEM | – | Other: Comparison of two approaches to bleeding managementBleeding and coagulopathy during surgery managed by ROTEM. Blood loss, consumption of fresh frozen plasma (FFP), red blood cell units consumption and time to aPTT/PT tests result will be analysed. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients who underwent surgical scoliosis correction
Key inclusion criteria (1 listed)
- pediatric patients after surgical correction of scoliosis
Key exclusion criteria (1 listed)
- patients older than 18 years
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 |
|---|---|---|
| Comparison of two approaches to bleeding management | Other | scoliosis bleeding management based on ROTEM, scoliosis bleeding management based on aPTT/PT |
Primary outcome
analysing blood loss during surgery
Time frame: 3 years
blood loss during scoliosis surgery will analysed in both groups
2 secondary outcomes
analysing blood transfusion units consumption
Time frame: 3 years
time to results of tests
Time frame: 3 years
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 11 Oct 2018.
- Derived from this study: PubMed 31978886Jonas J, Durila M, Malosek M, Maresova D, Stulik J, Barna M, Vymazal T. Usefulness of perioperative rotational thrombelastometry during scoliosis surgery in children. J Neurosurg Spine. 2020 Jan 24;32(6):865-870. doi: 10.3171/2019.11.SPINE191137. Print 2020 Jun 1.
- Individual participant dataSharing planned: Undecided. All data of study will be available in published paper
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation Defect; Bleeding, run by University Hospital, Motol.
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 1 inclusion and 1 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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
analysing blood loss during surgery (time frame: 3 years). 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 NCT03699813, 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 11 Oct 2018.