Evaluation of Hemostatics in coagulation inhibited human blood with viscoelastic testing (ROTEM)

Not Applicable

• Conditions: R58; D68.9; Haemorrhage, not elsewhere classified; Coagulation defect, unspecified

• Registration Number: DRKS00015034
• Lead Sponsor: Bundeswehrkrankenhaus UlmKlinik für Anästhesie und IntensivmedizinSektion Notfallmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-26
• Study Completion: 2022-03-19
• Results First Posted: 2023-03-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Control group:
- Healthy, especially concerning coagulation
- Informed consent

Intervention group:
- Regular medication of one of the following medications: Phenprocoumon, Enoxaparin, acetylsalicylic acid and Ticagrelor (combination), Dabigatran, Apixaban
- Informed consent
- Heparin Group: surgery with a mandatory heparin application during surgery

Exclusion Criteria

Control group:
- Bleeding disorders (e.g. haemophilia, factor 5 Leiden mutation)
- Medications within the last 10 days
- Regular medication
- Missing informed consent
- Malignancies of the haematopoietic system
- Status after diseases which caused a stay at hospital or doctor’s consultation during the last 14 days
- HES > 1,5 l during the past 4 weeks

Intervention group:
- Regular medication of more than one of the following: Phenprocoumon, Enoxaparin, acetylsalicylic acid and Ticagrelor, Dabigatran, Apixaban, acetylsalicylic acid
- Medications not at effective level
- No intake of the mentioned medications
- Intake of medications which influence coagulation but are not analyzed in this study
- Bleeding disorders (e.g. haemophilia, factor 5 Leiden mutation)
- Malignancies of the haematopoietic system
- Surgery in the past 14 days
- Stent implantation in the past 3 days
- Sepsis in the past 14 days
- HES > 1,5 l during the past 4 weeks
- Missing informed consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint is the clot formation, measured via thromelastometry (ROTEM Delta). <br><br>The measurement ist performed for 60 minutes. The measurement starts (in the intervention group) directly after incubation with the haemostyptic agent. <br><br>CT, CFT, MCF, ML, LI 30, LI 45, LI 60, alpha angle, A10, A20, AUC are determined. With the help of these data<br>- time until clot formation,<br>- speed of clot formation,<br>- clot firmness as well as<br>- clot lysis <br>can be estimated.<br><br><br><br>