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

Evaluation of Hemostatics in coagulation inhibited human blood with viscoelastic testing (ROTEM) - HemPIC (Hemostatics in Patients with Inhibited Coagulation)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015034

Enrollment

Registered

2018-10-26

Start date

2018-06-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R58 D68.9

Interventions

Group 1: Part 1 of the Study represents the control group with a physiologic coagulation, no medication in medical history. After clarification of all questions and obtaining a written consent the pa

Eligibility

Sex/Gender

Male

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Germany

Contacts

Public ContactMartin Kulla

Bundeswehrkrankenhaus UlmKlinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie

martin.kulla@uni-ulm.de0049 151 65613966

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026