Observational study on detecting postoperative bleeding after thyroid surgery
Thyroid HEmorrhage DetectOr Study
ISAR-M GmbH · NCT04845867
This study is testing a new way to check for bleeding after thyroid surgery to help doctors find problems early and improve recovery for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1470 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ISAR-M GmbH (industry) |
| Locations | 1 site (Hausham) |
| Trial ID | NCT04845867 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a diagnostic medical product in detecting postoperative bleeding in patients who have undergone thyroid surgery. It focuses on the early identification of complications by systematically measuring pressure in the thyroid compartment, which may indicate the presence of a hematoma. The study is observational and will involve multiple centers, with participants monitored for signs of bleeding within the critical first 48 hours post-surgery. The goal is to improve patient outcomes by enabling earlier intervention for serious complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for thyroid surgery and can provide informed consent.
Not a fit: Patients who are intended to have drains placed post-surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of severe complications and mortality associated with postoperative bleeding in thyroid surgery patients.
How similar studies have performed: While similar approaches to monitoring postoperative complications have been explored, this specific method of systematic pressure measurement in the thyroid compartment is novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years. * Indication for thyroid surgery (e.g. total thyroidectomy, subtotal resection, partial resection or lobectomy) in routine clinical care according to applicable medical guidelines using all adequate surgical approaches. * Signed informed consent Exclusion Criteria: \- Intended use of drains
Where this trial is running
Hausham
- Krankenhaus Agatharied — Hausham, Germany (RECRUITING)
Study contacts
- Study coordinator: Olivia Fedunik-Brehm
- Email: olivia.fedunik-brehm@isar-m.com
- Phone: +491735667761
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: Thyroid