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

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). 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.

Study Overview

• Status: Recruiting
• Conditions: Coagulation and Hemorrhagic Disorders
• Intervention / Treatment: Diagnostic test: Coagulation test on device ClotPro

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 175

Contacts and Locations

• Study Contact: Name: Kamil Vrbica, MD; Phone Number: 00420 532232543; Email: vrbica.kamil@fnbrno.cz
• Study Contact Backup: Name: Ondrej Hrdy, MD; Phone Number: 00420 532232009; Email: hrdy.ondrej@fnbrno.cz

Study Locations

• Czechia
  • Brno, Czechia, 625 00
    • Recruiting
    • University Hospital Brno
    • Contact: Ondrej Hrdy, M.D.; Phone Number: +420 532232305; Email: hrdy.ondrej@fnbrno.cz
    • Sub-Investigator: Ondrej Hrdy, M.D.
    • Contact: Kamil Vrbica, M.D.; Phone Number: +420 532232543; Email: vrbica.kamil@fnbrno.cz
    • Principal Investigator: Kamil Vrbica, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT for Ex-test on ClotPro® device	Clotting time for Ex-test ClotPro® device	before the labor
CT for In-test on ClotPro® device	Clotting time for In-test ClotPro® device	before the labor
CT for Fib-test on ClotPro® device	Clotting time for Fib-test ClotPro® device	before the labor
CFT for Ex-test on ClotPro® device	Clot formation time for Ex-test ClotPro® device	before the labor
CFT for In-test on ClotPro® device	Clot formation time for In-test ClotPro® device	before the labor
CFT for Fib-test on ClotPro® device	Clot formation time for Fib-test ClotPro® device	before the labor
A5 for Ex-test on ClotPro® device	Maximum clot firmness in 5th minute for Ex-test ClotPro® device	before the labor
A5 for In-test on ClotPro® device	Maximum clot firmness in 5th minute for In-test ClotPro® device	before the labor
A5 for Fib-test on ClotPro® device	Maximum clot firmness in 5th minute for Fib-test ClotPro® device	before the labor
A10 for Ex-test on ClotPro® device	Maximum clot firmness in 10th minute for Ex-test ClotPro® device	before the labor
A10 for In-test on ClotPro® device	Maximum clot firmness in 10th minute for In-test ClotPro® device	before the labor
A10 for Fib-test on ClotPro® device	Maximum clot firmness in 10th minute for Fib-test ClotPro® device	before the labor
A20 for Ex-test on ClotPro® device	Maximum clot firmness in 20th minute for Ex-test ClotPro® device	before the labor
A20 for In-test on ClotPro® device	Maximum clot firmness in 20th minute for In-test ClotPro® device	before the labor
A20 for Fib-test on ClotPro® device	Maximum clot firmness in 20th minute for Fib-test ClotPro® device	before the labor
MCF for Ex-test on ClotPro® device	Maximum clot firmness for Ex-test ClotPro® device	before the labor
MCF for In-test on ClotPro® device	Maximum clot firmness for In-test ClotPro® device	before the labor
MCF for Fib-test on ClotPro® device	Maximum clot firmness for Fib-test ClotPro® device	before the labor
ML for Ex-test on ClotPro® device	Maximum lysis for Ex-test ClotPro® device	before the labor
ML for In-test on ClotPro® device	Maximum lysis for In-test ClotPro® device	before the labor
ML for Fib-test on ClotPro® device	Maximum lysis for Fib-test ClotPro® device	before the labor
Hemoglobin level	Hemoglobin level	before the labor
Hematocrite level	Hematocrite level	before the labor
Platelet level	Platelet level	before the labor
Leucocytes level	Leucocytes level	before the labor
Fibrinogen level	Fibrinogen level	before the labor
Prothrombin time	Prothrombin time	before the labor
activated Partial thromboplastin time	activated Partial thromboplastin time	before the labor
INR	INR	before the labor
Thrombin time	Thrombin time	before the labor

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age	before the labor
Weight	Weight	before the labor
Weight	Weight	before pregnancy
Height	Height	before the labor
BMI	BMI	before the labor
BMI	BMI	before pregnancy
Number of pregnancies	Number of pregnancies	before the labor
Multiplicity of pregnancy	Multiplicity of pregnancy	before the labor
Smoking	Smoking	before the labor
Blood loss	Blood loss	immediately after the labor
Type of labour	spontaneous labor or cesarian section	immediately after the labor
Term of delivery	Term of delivery	immediately after the labor
Comparison of fibrinogen level and Fib-test	Comparison of fibrinogen level and Fib-test	before the labor
Comparison of Prothrombin time and CT in Ex-test	Camparison of Prothrombin time and CT in Ex-test	before the labor
Comparison of activated Partial thromboplastin time and In-test	Comparison of activated Partial thromboplastin time and In-test	before the labor
Comparison of BMI with Fib-test	Comparison of BMI with Fib-test	before the labor
Comparison of BMI with Ex-test	Comparison of BMI with Ex-test	before the labor
comparison of blood loss and Fib-test	determining the dependence between blood loss and Fib-test	immediately after the labor
comparison of blood loss and Ex-test	determining the dependence between blood loss and Ex-test	immediately after the labor

Collaborators and Investigators

• Sponsor: Ondrej Hrdy
• Investigators: Study Director: Roman Gal, prof, University Hospital Brno

Publications and helpful links

General Publications

• 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.
• 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.
• 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 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.
• 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 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.
• 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/aet480. Epub 2014 Jan 31.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Estimated): August 31, 2023
• Study Completion (Estimated): October 31, 2023

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy; Labor; Fibrinogen; Blood coagulation; Viscoelastic method
• Additional Relevant MeSH Terms: Hematologic Diseases; Hemorrhagic Disorders
• Other Study ID Numbers: 01-120423/EK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No