Thyroid HEmorrhage DetectOr Study

Thyroid Clinical Trial

— HEDOS  

Official title:

Thyroid HEmorrhage DetectOr Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04845867
• Other study ID #: HEDOS-2021
• Status: Not yet recruiting
• Start date: July 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: April 2021
• Source: ISAR-M GmbH
• Contact: Olivia Fedunik-Brehm
• Phone: +491735667761
• Email: olivia.fedunik-brehm[@]isar-m.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1470
• Est. completion date: August 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Thyroid
• Thyroid Diseases

Intervention

Device:
• ISAR-M THYRO
A diagnostic device for early detection of haemorrhage following thyroid surgery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ISAR-M GmbH	CRI-The Clinical Research Institute GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity	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
Primary	Sensitivity and specificity	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	Specificity	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
Secondary	Safety of the use of ISAR-M THYRO	Safety of the use of ISAR-M THYRO by means of adverse events within 1 month following thyroid surgery	1 month