Evaluation of Coagulation Status of Pregnant Women in the Peripartum Period Using the Device Clotpro®

Coagulation and Hemorrhagic Disorders Clinical Trial

Official title:

Evaluation of Coagulation Status of Pregnant Women in the Peripartum Period Using the Device Clotpro®, a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935137
• Other study ID #: 01-120423/EK
• Status: Recruiting
• Start date: May 26, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: July 2023
• Source: Brno University Hospital
• Contact: Kamil Vrbica, MD
• Phone: 532232543
• Email: vrbica.kamil[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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), as well as the dependence of the parameters on the number of pregnancies, multiple pregnancies and smoking.

Description:

This is a prospective observational 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). 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), as well as the dependence of the parameters on the number of pregnancies, multiple pregnancies and smoking.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: October 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

GROUP: Pregnant woman

Inclusion Criteria:

• Age 18 - 45 years

• BMI 18.5 - 30.0

• Negative pregnancy test

• The patient is able to sign an informed consent

Exclusion Criteria:

• 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

• History of hemato-oncological disease

• Refusal of inclusion in the study by the patient

GROUP: Non-pregnant group

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coagulation and Hemorrhagic Disorders
• Hemorrhagic Disorders

Intervention

Diagnostic Test:
• Coagulation test on device ClotPro
The blood sample for coagulation test on device ClotPro will be take for both group and the test will be provided.

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Ondrej Hrdy

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

de 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/ae — View Citation

Escobar 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 recommend — View Citation

Kietaibl 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. — View Citation

Rossaint 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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT for Ex-test on ClotPro® device	Clotting time for Ex-test ClotPro® device	before the labor
Primary	CT for In-test on ClotPro® device	Clotting time for In-test ClotPro® device	before the labor
Primary	CT for Fib-test on ClotPro® device	Clotting time for Fib-test ClotPro® device	before the labor
Primary	CFT for Ex-test on ClotPro® device	Clot formation time for Ex-test ClotPro® device	before the labor
Primary	CFT for In-test on ClotPro® device	Clot formation time for In-test ClotPro® device	before the labor
Primary	CFT for Fib-test on ClotPro® device	Clot formation time for Fib-test ClotPro® device	before the labor
Primary	A5 for Ex-test on ClotPro® device	Maximum clot firmness in 5th minute for Ex-test ClotPro® device	before the labor
Primary	A5 for In-test on ClotPro® device	Maximum clot firmness in 5th minute for In-test ClotPro® device	before the labor
Primary	A5 for Fib-test on ClotPro® device	Maximum clot firmness in 5th minute for Fib-test ClotPro® device	before the labor
Primary	A10 for Ex-test on ClotPro® device	Maximum clot firmness in 10th minute for Ex-test ClotPro® device	before the labor
Primary	A10 for In-test on ClotPro® device	Maximum clot firmness in 10th minute for In-test ClotPro® device	before the labor
Primary	A10 for Fib-test on ClotPro® device	Maximum clot firmness in 10th minute for Fib-test ClotPro® device	before the labor
Primary	A20 for Ex-test on ClotPro® device	Maximum clot firmness in 20th minute for Ex-test ClotPro® device	before the labor
Primary	A20 for In-test on ClotPro® device	Maximum clot firmness in 20th minute for In-test ClotPro® device	before the labor
Primary	A20 for Fib-test on ClotPro® device	Maximum clot firmness in 20th minute for Fib-test ClotPro® device	before the labor
Primary	MCF for Ex-test on ClotPro® device	Maximum clot firmness for Ex-test ClotPro® device	before the labor
Primary	MCF for In-test on ClotPro® device	Maximum clot firmness for In-test ClotPro® device	before the labor
Primary	MCF for Fib-test on ClotPro® device	Maximum clot firmness for Fib-test ClotPro® device	before the labor
Primary	ML for Ex-test on ClotPro® device	Maximum lysis for Ex-test ClotPro® device	before the labor
Primary	ML for In-test on ClotPro® device	Maximum lysis for In-test ClotPro® device	before the labor
Primary	ML for Fib-test on ClotPro® device	Maximum lysis for Fib-test ClotPro® device	before the labor
Primary	Hemoglobin level	Hemoglobin level	before the labor
Primary	Hematocrite level	Hematocrite level	before the labor
Primary	Platelet level	Platelet level	before the labor
Primary	Leucocytes level	Leucocytes level	before the labor
Primary	Fibrinogen level	Fibrinogen level	before the labor
Primary	Prothrombin time	Prothrombin time	before the labor
Primary	activated Partial thromboplastin time	activated Partial thromboplastin time	before the labor
Primary	INR	INR	before the labor
Primary	Thrombin time	Thrombin time	before the labor
Secondary	Age	Age	before the labor
Secondary	Weight	Weight	before the labor
Secondary	Weight	Weight	before pregnancy
Secondary	Height	Height	before the labor
Secondary	BMI	BMI	before the labor
Secondary	BMI	BMI	before pregnancy
Secondary	Number of pregnancies	Number of pregnancies	before the labor
Secondary	Multiplicity of pregnancy	Multiplicity of pregnancy	before the labor
Secondary	Smoking	Smoking	before the labor
Secondary	Blood loss	Blood loss	immediately after the labor
Secondary	Type of labour	spontaneous labor or cesarian section	immediately after the labor
Secondary	Term of delivery	Term of delivery	immediately after the labor
Secondary	Comparison of fibrinogen level and Fib-test	Comparison of fibrinogen level and Fib-test	before the labor
Secondary	Comparison of Prothrombin time and CT in Ex-test	Camparison of Prothrombin time and CT in Ex-test	before the labor
Secondary	Comparison of activated Partial thromboplastin time and In-test	Comparison of activated Partial thromboplastin time and In-test	before the labor
Secondary	Comparison of BMI with Fib-test	Comparison of BMI with Fib-test	before the labor
Secondary	Comparison of BMI with Ex-test	Comparison of BMI with Ex-test	before the labor
Secondary	comparison of blood loss and Fib-test	determining the dependence between blood loss and Fib-test	immediately after the labor
Secondary	comparison of blood loss and Ex-test	determining the dependence between blood loss and Ex-test	immediately after the labor