Thyroid HEmorrhage DetectOr Study (HEDOS)

• ClinicalTrials.gov Identifier: NCT04845867
• Recruitment Status: Not yet recruiting
• First Posted: April 15, 2021
• Last Update Posted: April 15, 2021
• Sponsor: ISAR-M GmbH
• Collaborator: CRI-The Clinical Research Institute GmbH
• Information provided by (Responsible Party): ISAR-M GmbH

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Thyroid	Device: ISAR-M THYRO

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 1470 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 1 Month
• Official Title: Thyroid HEmorrhage DetectOr Study
• Estimated Study Start Date: July 1, 2021
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: August 31, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Measurement and digital documentation; continuous measurement and digital documentation with alarms and display off	Device: ISAR-M THYRO; A diagnostic device for early detection of haemorrhage following thyroid surgery

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Secondary Outcome Measures :

1. 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
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Contacts

Contact: Olivia Fedunik-Brehm; +491735667761; olivia.fedunik-brehm@isar-m.com

Contact: Sabrina Koschel; +49 89 9901649975; hedos@cri-muc.eu

Sponsors and Collaborators

ISAR-M GmbH

CRI-The Clinical Research Institute GmbH

Investigators

• Study Chair: Ulrich Wirth, Dr.; Clinic for General, Visceral, Vascular and Transplant Surgery - Großhadern Campus,

More Information

• Responsible Party: ISAR-M GmbH
• ClinicalTrials.gov Identifier: NCT04845867
• Other Study ID Numbers: HEDOS-2021
• First Posted: April 15, 2021
• Last Update Posted: April 15, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Thyroid Diseases; Hemorrhage; Pathologic Processes; Endocrine System Diseases