Coagulation and Hemorrhagic DisordersNCT05935137
Evaluation of Coagulation Status of Pregnant Women in the Peripartum Period Using the Device Clotpro®
An observational study of Coagulation and Hemorrhagic Disorders, run by Ondrej Hrdy at 1 site in Czechia.
Trial summary
The primary aim of the study is to determine the physiological parameters of the coagulation status of pregnant women in the peripartum period (PWPP) for the ClotPro® device - Ex-test (CT, CFT, MCF, A5, A10, A20, ML), In-test (CT, CFT, MCF, A5, A10, A20, ML) and Fib-test (CT, CFT, MCF, A5, A10, A20, ML) and based on… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Coagulation and Hemorrhagic Disorders
- What is being tested?
- Coagulation test on device ClotPro
- How many people
- 175 participants
- Where
- 1 siteCzechia
- Study dates
- 26 May 2023to 17 Jan 2024
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: GROUP: Pregnant woman Population of pregnant women fulfilling all inclusion criteria and none of exclusion criteria. GROUP: Non-pregnant group Population of non-pregnant women fulfilling all inclusion criteria and none of exclusion criteria.
Who may be able to join
- Age 18 - 45 years
- BMI 18.5 - 30.0
- Negative pregnancy test
- The patient is able to sign an informed consent
- A pregnant woman admitted to Department of gynecology and obstetrics for the labor at the physiological term (38th week (38+0) and more)
- Age 18 - 45 years
Show all 9Show fewer
- BMI 18.5 - 30.0 (before pregnancy)
- Blood samples are indicated for standard blood samples before labor
- The patient is able to sign an informed consent at the time of admission
Who cannot join
- Antiplatelet treatment
- Anticoagulation treatment
- Hereditary or acquired coagulopathy
- History of thrombosis or pulmonary embolism
- Acute or chronic inflammation (fever, septic condition, autoimmune disease)
- Active bleeding
Show all 23Show fewer
- History of hemato-oncological disease
- Refusal of inclusion in the study by the patient
- GROUP: Non-pregnant group
- Antiplatelet treatment
- Anticoagulation treatment
- Hereditary or acquired coagulopathy
- History of thrombosis or pulmonary embolism
- Acute or chronic inflammation (fever, septic condition, autoimmune disease)
- Active bleeding
- Preeclampsia
- Eclampsia
- Gestational diabetes
- Abruption of the placenta
- HELLP syndrome
- History of hemato-oncological disease
- Pregnancy in last 6 months
- Refusal of inclusion in the study by the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Coagulation Status of Pregnant Women in the Peripartum Period Using the Device Clotpro®, a Prospective Observational Study
The primary aim of the study is to determine the physiological parameters of the coagulation status of pregnant women in the peripartum period (PWPP) for the ClotPro® device - Ex-test (CT, CFT, MCF, A5, A10, A20, ML), In-test (CT, CFT, MCF, A5, A10, A20, ML) and Fib-test (CT, CFT, MCF, A5, A10, A20, ML) and based on these results, establish ClotPro® reference ranges in parturients. The secondary aim is to compare the difference in coagulation parameters between pregnant women in the peripartum period and a control group of non-pregnant women (NPW) on the ClotPro® device. Furthermore, a comparison with the physiological parameters of pregnant women in the peripartum period intended for ROTEM® and TEG® devices (they are already known).
Read the detailed description
This is a prospective observational cross-sectional study with a control group whose task is to describe the physiological parameters of the coagulation status of pregnant women in the peripartum period measured on the ClotPro® device. The study is monocentric and will take place at the Brno University Hospital. The study will evaluate a group of pregnant women in the peripartum period who come to give birth at the Brno University Hospital and fulfill the inclusion criteria, the target number is 120 patients. A control group of non-pregnant patients who fulfill the inclusion criteria to verify the difference between pregnant patients in the peripartum period and non-pregnant patients will also be included, the target number is 40 patients. For the participant the study is completed after obtaining the results from the ClotPro® device, there will be no reaction to result. The study is an academic research project, not sponsored by a private entity, and data will not be provided to a private entity.
The primary aim of the study is to determine the physiological parameters of the coagulation status of pregnant women in the peripartum period (PWPP) for the ClotPro® device - Ex-test (CT, CFT, MCF, A5, A10, A20, ML), In-test (CT, CFT, MCF, A5, A10, A20, ML) and Fib-test (CT, CFT, MCF, A5, A10, A20, ML) and based on these results, establish ClotPro® reference ranges in parturients. The secondary aim is to compare the difference in coagulation parameters between pregnant women in the peripartum period and a control group of non-pregnant women (NPW) on the ClotPro® device. Furthermore, a comparison with the physiological parameters of pregnant women in the peripartum period intended for ROTEM® and TEG® devices (they are already known).
- Conditions
- Coagulation and Hemorrhagic Disorders
- Being tested
- Coagulation test on device ClotPro
- Keywords
- Blood coagulation, Fibrinogen, Viscoelastic method, Pregnancy, Labor
- Medical subject headings
- Thrombosis, Hemorrhagic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coagulation test on device ClotProDiagnostic test
The blood sample for coagulation test on device ClotPro will be take for both group and the test will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | It is a group of pregnant women after finished 37th week of gestation. We will take blood sample for a coagulation test on the device ClotPro.There is no more intervention. Receives: Diagnostic Test: Coagulation test on device ClotPro | |
| Non-pregnant women | It is a control group - non-pregnant women. We will take blood samples for blood count and coagulation status and a coagulation test on the device ClotPro.There is no more intervention. Receives: Diagnostic Test: Coagulation test on device ClotPro |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT for Ex-test on ClotPro® device
Clotting time for Ex-test ClotPro® device
Measured: before the labor
CT for In-test on ClotPro® device
Clotting time for In-test ClotPro® device
Measured: before the labor
CT for Fib-test on ClotPro® device
Clotting time for Fib-test ClotPro® device
Measured: before the labor
CFT for Ex-test on ClotPro® device
Clot formation time for Ex-test ClotPro® device
Measured: before the labor
CFT for In-test on ClotPro® device
Clot formation time for In-test ClotPro® device
Measured: before the labor
CFT for Fib-test on ClotPro® device
Clot formation time for Fib-test ClotPro® device
Measured: before the labor
A5 for Ex-test on ClotPro® device
Maximum clot firmness in 5th minute for Ex-test ClotPro® device
Measured: before the labor
A5 for In-test on ClotPro® device
Maximum clot firmness in 5th minute for In-test ClotPro® device
Measured: before the labor
A5 for Fib-test on ClotPro® device
Maximum clot firmness in 5th minute for Fib-test ClotPro® device
Measured: before the labor
A10 for Ex-test on ClotPro® device
Maximum clot firmness in 10th minute for Ex-test ClotPro® device
Measured: before the labor
A10 for In-test on ClotPro® device
Maximum clot firmness in 10th minute for In-test ClotPro® device
Measured: before the labor
A10 for Fib-test on ClotPro® device
Maximum clot firmness in 10th minute for Fib-test ClotPro® device
Measured: before the labor
A20 for Ex-test on ClotPro® device
Maximum clot firmness in 20th minute for Ex-test ClotPro® device
Measured: before the labor
A20 for In-test on ClotPro® device
Maximum clot firmness in 20th minute for In-test ClotPro® device
Measured: before the labor
A20 for Fib-test on ClotPro® device
Maximum clot firmness in 20th minute for Fib-test ClotPro® device
Measured: before the labor
MCF for Ex-test on ClotPro® device
Maximum clot firmness for Ex-test ClotPro® device
Measured: before the labor
MCF for In-test on ClotPro® device
Maximum clot firmness for In-test ClotPro® device
Measured: before the labor
MCF for Fib-test on ClotPro® device
Maximum clot firmness for Fib-test ClotPro® device
Measured: before the labor
ML for Ex-test on ClotPro® device
Maximum lysis for Ex-test ClotPro® device
Measured: before the labor
ML for In-test on ClotPro® device
Maximum lysis for In-test ClotPro® device
Measured: before the labor
ML for Fib-test on ClotPro® device
Maximum lysis for Fib-test ClotPro® device
Measured: before the labor
Hemoglobin level
Hemoglobin level
Measured: before the labor
Hematocrite level
Hematocrite level
Measured: before the labor
Platelet level
Platelet level
Measured: before the labor
Leucocytes level
Leucocytes level
Measured: before the labor
Fibrinogen level
Fibrinogen level
Measured: before the labor
Prothrombin time
Prothrombin time
Measured: before the labor
activated Partial thromboplastin time
activated Partial thromboplastin time
Measured: before the labor
INR
INR
Measured: before the labor
Thrombin time
Thrombin time
Measured: before the labor
Establish ClotPro® reference ranges in parturients
Reference ranges will be established according to IFCC guidelines, based on physiological coagulation parameters measured in parturient women using the ClotPro® device.
Measured: before the labor
Secondary outcomes (15)
Age
Age
Measured: before the labor
Weight
Weight
Measured: before the labor
Weight
Weight
Measured: before pregnancy
Height
Height
Measured: before the labor
BMI
BMI
Measured: before the labor
BMI
BMI
Measured: before pregnancy
Number of pregnancies
Number of pregnancies
Measured: before the labor
Multiplicity of pregnancy
Multiplicity of pregnancy
Measured: before the labor
Smoking
Smoking
Measured: before the labor
Blood loss
Blood loss
Measured: immediately after the labor
Type of labour
spontaneous labor or cesarian section
Measured: immediately after the labor
Term of delivery
Term of delivery
Measured: immediately after the labor
Comparison of fibrinogen level and Fib-test
Comparison of fibrinogen level and Fib-test
Measured: before the labor
Comparison of Prothrombin time and CT in Ex-test
Camparison of Prothrombin time and CT in Ex-test
Measured: before the labor
Comparison of activated Partial thromboplastin time and In-test
Comparison of activated Partial thromboplastin time and In-test
Measured: before the labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start26 May 2023
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coagulation and Hemorrhagic DisordersStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondrej Hrdy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ondrej Hrdy, Brno University Hospital
- Investigators
- Roman Gal, prof, Study director, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935137
- Sponsor's protocol ID
- 01-120423/EK
- Status last verified
- Apr 2025
- First submitted
- 25 May 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
PubMed 25103301Escobar MF, Nassar AH, Theron G, Barnea ER, Nicholson W, Ramasauskaite D, Lloyd I, Chandraharan E, Miller S, Burke T, Ossanan G, Andres Carvajal J, Ramos I, Hincapie MA, Loaiza S, Nasner D; FIGO Safe Motherhood and Newborn Health Committee. FIGO recommendations on the management of postpartum hemorrhage 2022. Int J Gynaecol Obstet. 2022 Mar;157 Suppl 1(Suppl 1):3-50. doi: 10.1002/ijgo.14116. No abstract available.
PubMed 35297039Kietaibl S, Ahmed A, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Godier A, Haas T, Jacob M, Lance MD, Llau JV, Meier J, Molnar Z, Mora L, Rahe-Meyer N, Samama CM, Scarlatescu E, Schlimp C, Wikkelso AJ, Zacharowski K. Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care: Second update 2022. Eur J Anaesthesiol. 2023 Apr 1;40(4):226-304. doi: 10.1097/EJA.0000000000001803.
PubMed 36855941Rossaint R, Afshari A, Bouillon B, Cerny V, Cimpoesu D, Curry N, Duranteau J, Filipescu D, Grottke O, Gronlykke L, Harrois A, Hunt BJ, Kaserer A, Komadina R, Madsen MH, Maegele M, Mora L, Riddez L, Romero CS, Samama CM, Vincent JL, Wiberg S, Spahn DR. The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition. Crit Care. 2023 Mar 1;27(1):80. doi: 10.1186/s13054-023-04327-7.
PubMed 36859355de Lange NM, van Rheenen-Flach LE, Lance MD, Mooyman L, Woiski M, van Pampus EC, Porath M, Bolte AC, Smits L, Henskens YM, Scheepers HC. Peri-partum reference ranges for ROTEM(R) thromboelastometry. Br J Anaesth. 2014 May;112(5):852-9. doi: 10.1093/bja/aet480. Epub 2014 Jan 31.
PubMed 24486836
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Coagulation Status of Pregnant Women in the Peripartum Period Using the Device Clotpro®, a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05935137
- Acronym / sponsor ID
- 01-120423/EK
- Conditions
- Coagulation and Hemorrhagic Disorders
- Keywords
- Blood coagulation, Fibrinogen, Viscoelastic method, Pregnancy, Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Ondrej HrdyUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 7 Jul 2023 (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.
The primary aim of the study is to determine the physiological parameters of the coagulation status of pregnant women in the peripartum period (PWPP) for the ClotPro® device - Ex-test (CT, CFT, MCF, A5, A10, A20, ML), In-test (CT, CFT, MCF, A5, A10, A20, ML) and Fib-test (CT, CFT, MCF, A5, A10, A20, ML) and based on these results, establish ClotPro® reference ranges in parturients. The secondary aim is to compare the difference in coagulation parameters between pregnant women in the peripartum period and a control group of non-pregnant women (NPW) on the ClotPro® device. Furthermore, a comparison with the physiological parameters of pregnant women in the peripartum period intended for ROTEM® and TEG® devices (they are already known).
Detailed description
This is a prospective observational cross-sectional study with a control group whose task is to describe the physiological parameters of the coagulation status of pregnant women in the peripartum period measured on the ClotPro® device. The study is monocentric and will take place at the Brno University Hospital. The study will evaluate a group of pregnant women in the peripartum period who come to give birth at the Brno University Hospital and fulfill the inclusion criteria, the target number is 120 patients. A control group of non-pregnant patients who fulfill the inclusion criteria to verify the difference between pregnant patients in the peripartum period and non-pregnant patients will also be included, the target number is 40 patients. For the participant the study is completed after obtaining the results from the ClotPro® device, there will be no reaction to result. The study is an academic research project, not sponsored by a private entity, and data will not be provided to a private entity.
The primary aim of the study is to determine the physiological parameters of the coagulation status of pregnant women in the peripartum period (PWPP) for the ClotPro® device - Ex-test (CT, CFT, MCF, A5, A10, A20, ML), In-test (CT, CFT, MCF, A5, A10, A20, ML) and Fib-test (CT, CFT, MCF, A5, A10, A20, ML) and based on these results, establish ClotPro® reference ranges in parturients. The secondary aim is to compare the difference in coagulation parameters between pregnant women in the peripartum period and a control group of non-pregnant women (NPW) on the ClotPro® device. Furthermore, a comparison with the physiological parameters of pregnant women in the peripartum period intended for ROTEM® and TEG® devices (they are already known).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Diagnostic Test: Coagulation test on device ClotProIt is a group of pregnant women after finished 37th week of gestation. We will take blood sample for a coagulation test on the device ClotPro.There is no more intervention. |
| Non-pregnant women | – | Diagnostic Test: Coagulation test on device ClotProIt is a control group - non-pregnant women. We will take blood samples for blood count and coagulation status and a coagulation test on the device ClotPro.There is no more intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- GROUP: Pregnant woman Population of pregnant women fulfilling all inclusion criteria and none of exclusion criteria. GROUP: Non-pregnant group Population of non-pregnant women fulfilling all inclusion criteria and none of exclusion criteria.
Key inclusion criteria (9 listed)
- Age 18 - 45 years
- BMI 18.5 - 30.0
- Negative pregnancy test
- The patient is able to sign an informed consent
- A pregnant woman admitted to Department of gynecology and obstetrics for the labor at the physiological term (38th week (38+0) and more)
Key exclusion criteria (23 listed)
- Antiplatelet treatment
- Anticoagulation treatment
- Hereditary or acquired coagulopathy
- History of thrombosis or pulmonary embolism
- Acute or chronic inflammation (fever, septic condition, autoimmune disease)
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 test on device ClotProThe blood sample for coagulation test on device ClotPro will be take for both group and the test will be provided. | Diagnostic test | Non-pregnant women, Pregnant women |
Primary outcome
CT for Ex-test on ClotPro® device
Time frame: before the labor
Clotting time for Ex-test ClotPro® device
CT for In-test on ClotPro® device
Time frame: before the labor
Clotting time for In-test ClotPro® device
CT for Fib-test on ClotPro® device
Time frame: before the labor
Clotting time for Fib-test ClotPro® device
CFT for Ex-test on ClotPro® device
Time frame: before the labor
Clot formation time for Ex-test ClotPro® device
CFT for In-test on ClotPro® device
Time frame: before the labor
Clot formation time for In-test ClotPro® device
CFT for Fib-test on ClotPro® device
Time frame: before the labor
Clot formation time for Fib-test ClotPro® device
A5 for Ex-test on ClotPro® device
Time frame: before the labor
Maximum clot firmness in 5th minute for Ex-test ClotPro® device
A5 for In-test on ClotPro® device
Time frame: before the labor
Maximum clot firmness in 5th minute for In-test ClotPro® device
A5 for Fib-test on ClotPro® device
Time frame: before the labor
Maximum clot firmness in 5th minute for Fib-test ClotPro® device
A10 for Ex-test on ClotPro® device
Time frame: before the labor
Maximum clot firmness in 10th minute for Ex-test ClotPro® device
A10 for In-test on ClotPro® device
Time frame: before the labor
Maximum clot firmness in 10th minute for In-test ClotPro® device
A10 for Fib-test on ClotPro® device
Time frame: before the labor
Maximum clot firmness in 10th minute for Fib-test ClotPro® device
A20 for Ex-test on ClotPro® device
Time frame: before the labor
Maximum clot firmness in 20th minute for Ex-test ClotPro® device
A20 for In-test on ClotPro® device
Time frame: before the labor
Maximum clot firmness in 20th minute for In-test ClotPro® device
A20 for Fib-test on ClotPro® device
Time frame: before the labor
Maximum clot firmness in 20th minute for Fib-test ClotPro® device
MCF for Ex-test on ClotPro® device
Time frame: before the labor
Maximum clot firmness for Ex-test ClotPro® device
MCF for In-test on ClotPro® device
Time frame: before the labor
Maximum clot firmness for In-test ClotPro® device
MCF for Fib-test on ClotPro® device
Time frame: before the labor
Maximum clot firmness for Fib-test ClotPro® device
ML for Ex-test on ClotPro® device
Time frame: before the labor
Maximum lysis for Ex-test ClotPro® device
ML for In-test on ClotPro® device
Time frame: before the labor
Maximum lysis for In-test ClotPro® device
ML for Fib-test on ClotPro® device
Time frame: before the labor
Maximum lysis for Fib-test ClotPro® device
Hemoglobin level
Time frame: before the labor
Hemoglobin level
Hematocrite level
Time frame: before the labor
Hematocrite level
Platelet level
Time frame: before the labor
Platelet level
Leucocytes level
Time frame: before the labor
Leucocytes level
Fibrinogen level
Time frame: before the labor
Fibrinogen level
Prothrombin time
Time frame: before the labor
Prothrombin time
activated Partial thromboplastin time
Time frame: before the labor
activated Partial thromboplastin time
INR
Time frame: before the labor
INR
Thrombin time
Time frame: before the labor
Thrombin time
Establish ClotPro® reference ranges in parturients
Time frame: before the labor
Reference ranges will be established according to IFCC guidelines, based on physiological coagulation parameters measured in parturient women using the ClotPro® device.
15 secondary outcomes
Age
Time frame: before the labor
Weight
Time frame: before the labor
Weight
Time frame: before pregnancy
Height
Time frame: before the labor
BMI
Time frame: before the labor
BMI
Time frame: before pregnancy
Number of pregnancies
Time frame: before the labor
Multiplicity of pregnancy
Time frame: before the labor
Smoking
Time frame: before the labor
Blood loss
Time frame: immediately after the labor
Type of labour
Time frame: immediately after the labor
Term of delivery
Time frame: immediately after the labor
Comparison of fibrinogen level and Fib-test
Time frame: before the labor
Comparison of Prothrombin time and CT in Ex-test
Time frame: before the labor
Comparison of activated Partial thromboplastin time and In-test
Time frame: before the labor
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 24 Apr 2025.
- Results publication: PubMed 25103301Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
- Results publication: PubMed 35297039Escobar MF, Nassar AH, Theron G, Barnea ER, Nicholson W, Ramasauskaite D, Lloyd I, Chandraharan E, Miller S, Burke T, Ossanan G, Andres Carvajal J, Ramos I, Hincapie MA, Loaiza S, Nasner D; FIGO Safe Motherhood and Newborn Health Committee. FIGO recommendations on the management of postpartum hemorrhage 2022. Int J Gynaecol Obstet. 2022 Mar;157 Suppl 1(Suppl 1):3-50. doi: 10.1002/ijgo.14116. No abstract available.
- Results publication: PubMed 36855941Kietaibl S, Ahmed A, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Godier A, Haas T, Jacob M, Lance MD, Llau JV, Meier J, Molnar Z, Mora L, Rahe-Meyer N, Samama CM, Scarlatescu E, Schlimp C, Wikkelso AJ, Zacharowski K. Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care: Second update 2022. Eur J Anaesthesiol. 2023 Apr 1;40(4):226-304. doi: 10.1097/EJA.0000000000001803.
- Results publication: PubMed 36859355Rossaint R, Afshari A, Bouillon B, Cerny V, Cimpoesu D, Curry N, Duranteau J, Filipescu D, Grottke O, Gronlykke L, Harrois A, Hunt BJ, Kaserer A, Komadina R, Madsen MH, Maegele M, Mora L, Riddez L, Romero CS, Samama CM, Vincent JL, Wiberg S, Spahn DR. The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition. Crit Care. 2023 Mar 1;27(1):80. doi: 10.1186/s13054-023-04327-7.
- Results publication: PubMed 24486836de Lange NM, van Rheenen-Flach LE, Lance MD, Mooyman L, Woiski M, van Pampus EC, Porath M, Bolte AC, Smits L, Henskens YM, Scheepers HC. Peri-partum reference ranges for ROTEM(R) thromboelastometry. Br J Anaesth. 2014 May;112(5):852-9. doi: 10.1093/bja/aet480. Epub 2014 Jan 31.
- Individual participant dataSharing planned: No
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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.
Roman Gal, prof study director
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 Coagulation and Hemorrhagic Disorders, run by Ondrej Hrdy 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 9 inclusion and 23 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 24 Apr 2025. 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?
CT for Ex-test on ClotPro® device (time frame: before the labor). The study lists 31 primary outcomes in all. 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 NCT05935137, which also lists 5 linked publications.
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 24 Apr 2025.