Personalized bleeding management using viscoelastic testing in liver surgery, neurosurgery, and obstetrics
Personalized ViscoElastic Testing-guided Bleeding Management In Liver Surgery, Neurosurgery and Obstetrics - a Prospective Comparison of the Novel ClotPro With ROTEM and TEG
Medical University of Vienna · NCT06635564
This study is testing a new blood testing device called ClotPro to see if it can better help manage bleeding during liver surgery, cesarean sections, and brain surgery compared to other devices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna (other) |
| Locations | 1 site (Vienna, Austria) |
| Trial ID | NCT06635564 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of the ClotPro analyzer, a viscoelastic testing device, in assessing blood coagulation in three patient cohorts: those undergoing liver surgery, pregnant women having elective cesarean sections, and patients undergoing elective intracranial neurosurgery. The study aims to compare ClotPro results with those from other viscoelastic testing devices, ROTEM delta and TEG 6s, to determine their agreement and predictive ability for perioperative bleeding and thromboembolic events. Additionally, it seeks to explore whether cohort-specific reference ranges for ClotPro are necessary and to identify any sex-specific differences in coagulation management. The findings could lead to a personalized approach to perioperative coagulation management.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing elective liver surgery, pregnant women scheduled for cesarean sections, and individuals requiring elective intracranial neurosurgery.
Not a fit: Patients not undergoing any of the specified surgical procedures or those with acute bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance personalized bleeding management strategies, potentially reducing perioperative complications for patients.
How similar studies have performed: While viscoelastic testing has been explored in various contexts, this specific comparative approach with ClotPro is novel and has not been extensively tested in these patient cohorts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Vulnerable patient cohorts
* Patients undergoing elective liver surgery defined as one of the following invasive procedures:
* Liver resection (anatomic or non-anatomic segmental resection, right or left hepatectomy, right or left extended hepatectomy),
* Orthotopic liver transplantation,
* Pregnant women undergoing an elective caesarean section, and
* Patients undergoing an elective intracranial neurosurgery.
2. Written informed consent
Exclusion Criteria:
none
Where this trial is running
Vienna, Austria
- Medical University of Vienna — Vienna, Austria, Austria (RECRUITING)
Study contacts
- Principal investigator: Johannes Gratz, PhD MD — Medical University of Vienna
- Study coordinator: Nikolaus Hofmann, MD
- Email: nikolaus.hofmann@meduniwien.ac.at
- Phone: 00436645379719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thrombelastography, Liver Transplant, Postpartum Hemorrhage, Bleeding Disorder, Intracranial Hemorrhages, Viscoelastic testing, personalized bleeding management