- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04845867
Thyroid HEmorrhage DetectOr Study (HEDOS)
April 13, 2021 updated by: ISAR-M GmbH
After thyroid surgery, 0.6 to 4% of patients develop postoperative bleeding.
90% of this postoperative bleeding occurs within the first 48 hours.
Most of the time, the complications are rapidly progressing and require immediate attention.
Up to 0.6% of patients with postoperative bleeding die.
In a clinical study with postoperative pressure measurements it could be shown that postoperative bleeding without interruption leads to a continuous increase in pressure in the neck, as is observed when coughing and pressing.
Systematic invasive pressure measurement in the thyroid compartment after surgery might detect a continuous increase in pressure which is often caused by a growing haematoma, indicating serious post-surgery bleeding at a much earlier time compared to state of the art diagnostic workflow.
n routine clinical care, detection of serious haemorrhage depends on the patients alerting symptoms even if post-operative intermittent monitoring of vital parameters and wound conditions is performed according to current medical guidelines [18] and local instructions.
Device-based, continuous haemorrhage detection within 36 to 48 hours after surgery would allow to objectively measure an increase in cervical pressure before symptoms occur, i.e. early detection of risk leading to timely therapeutic actions.
Thus, the risk of serious complications like hypoxic brain damage and death caused by post-operative haemorrhage is minimized.
In addition, the intervention team would be able to fine-tune necessary actions during the rescue procedure based on objective pressure values, e.g. the decision to open cutaneous sutures immediately or later in the operation theatre, and therefore reduce additional perioperative morbidity and increase patients' safety.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
1470
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Olivia Fedunik-Brehm
- Phone Number: +491735667761
- Email: olivia.fedunik-brehm@isar-m.com
Study Contact Backup
- Name: Sabrina Koschel
- Phone Number: +49 89 9901649975
- Email: hedos@cri-muc.eu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
HEDOS will enrol and measure presumably 1,470 eligible adult patients and follow each of them for 1 month, assuming that 22 cases of clinically relevant haemorrhage within 48 hours following thyroid surgery will be observed.
It will be conducted in Germany and Austria with about 50 clinical sites participating.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Measurement and digital documentation
continuous measurement and digital documentation with alarms and display off
|
A diagnostic device for early detection of haemorrhage following thyroid surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity
Time Frame: within 48 hours following thyroid surgery
|
detection of clinically relevant haemorrhage compared to the gold standard of detection in routine clinical care using 15 mmHg as cut-off
|
within 48 hours following thyroid surgery
|
Sensitivity and specificity
Time Frame: within 48 hours following thyroid surgery
|
Sensitivity and specificity of detection of clinically relevant haemorrhage within 48 hours following thyroid surgery compared to the gold standard of routine clinical care detection in a three-level decision system using 10 and 20 mmHg as cut-offs
|
within 48 hours following thyroid surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specificity
Time Frame: within 48 hours following thyroid surgery
|
Specificity as well as positive and negative predictive values of detection of clinically relevant haemorrhage within 48 hours following thyroid surgery compared to the gold standard of detection in routine clinical care using the two-level and the three-level decision system.following
thyroid surgery compared to the gold standard of routine clinical care detection in routine clinical care using the two-level and three-level decision system
|
within 48 hours following thyroid surgery
|
Safety of the use of ISAR-M THYRO
Time Frame: 1 month
|
Safety of the use of ISAR-M THYRO by means of adverse events within 1 month following thyroid surgery
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Ulrich Wirth, Dr., Clinic for General, Visceral, Vascular and Transplant Surgery - Großhadern Campus,
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2021
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
August 31, 2022
Study Registration Dates
First Submitted
April 13, 2021
First Submitted That Met QC Criteria
April 13, 2021
First Posted (Actual)
April 15, 2021
Study Record Updates
Last Update Posted (Actual)
April 15, 2021
Last Update Submitted That Met QC Criteria
April 13, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEDOS-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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