Autopsy and Photon Counting Computed Tomography to Evaluate Thromboses Related to Central Venous Catheters

NCT06417541 | Recruiting

• 1 other identifier: PHOTO CAT
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Central venous (CVC) is essential in modern healthcare but unfortunately associated with complications, including thrombosis. In a recently published study, it was showed that 12 out of 12 deceased patients had subclinical CVK-related thrombosis (Rockholt et al.). To shed light on this problem, the current studies were designed. In sub-study 1, deceased patients with CVC who are referred for clinical autopsy are included. Before the autopsy, the deceased will be examined with a photon-counting computed tomography (CT) scan and the results will be compared. In sub-study 2, living patients with CVC who are referred for various CT scans without contrast, are included. After informed consent, the patient will be examined with the photon-counting CT, whose reliability has been validated in Part 1 and the incidence of subclinical CVC-related thrombosis will be reported.

Conditions

Central Venous Catheter Thrombosis

Keywords

central venous catheter; thrombosis; photon counting ct

Outcome Measures

Primary Outcomes (4)

• The incidence of venous thrombosis related to a central venous catheter in diseased patients

  Venous thrombosis related to a central venous catheter detected at autopsy

  At autopsy

• The performance of the photon counting CT on diseased patients

  The performance of the photon counting CT will be evaluated by comparing the findings from the CT with the findings from the autopsy

  After death. The CT scan and the autopsy will be performed within 1 week after death

• The incidence of venous thrombosis related to a central venous catheter in living patients

  The incidence of venous thrombosis related to a central venous catheter in living patients detected with a photon counting CT

  At CT scan

• The performance of ultrasound compared to the photon counting CT

  The performance of ultrasound compared to the photon counting CT in detecting enous thrombosis related to central venous catheters

  Ultrasound will be performed ±24 hours from the CT

Study Arms (2)

Diseased patients with an indwelling central venous catheter

Sub study 1, Diseased patients with an indwelling central venous catheter

Diagnostic Test: Diseased patients with an indwelling central venous catheter who is referred to autopsy

Living patients with an indwelling central venous catheter

Living patients with an indwelling central venous catheter who are referred to a CT-scan without intravenous contrast

Radiation: Living patients with an indwelling central venous catheter referred to a CT scan without iv contrast

Interventions

Living patients with an indwelling central venous catheter referred to a CT scan without iv contrast RADIATION

Patients will be investigated using a photon counting CT. Prior to the investigation patients will be investigated with ultrasound. The results from the two modalities will be compared

Living patients with an indwelling central venous catheter

Diseased patients with an indwelling central venous catheter who is referred to autopsy DIAGNOSTIC_TEST

Photon counting CT is performed and the results are compared to the results of the autopsy

Diseased patients with an indwelling central venous catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Substudy 1: Diseased patients with an indwelling central venous catheter and a clinical indication for autopsy Substudy 2: Living patients with an indwelling central venous catheter who are referred to a CT scan without iv contrast

You may qualify if:

• Diseased patients with an indwelling central venous catheter and a clinical indication for autopsy
• Informed and signed consent from next of kind

You may not qualify if:

• None
• Living patients with an indwelling central venous catheter who are referred to a CT scan without iv contrast
• Informed and signed consent from the patient
• \- GFR \<15 mL/min/1.73 m2

Sponsors & Collaborators

• Thomas Kander: lead

Study Sites (1)

Intensive and Perioperative Care. Skåne University Hospital. Lund

Lund, Skåne County, 22185, Sweden

RECRUITING

Related Publications (3)

• Forauer AR, Theoharis C. Histologic changes in the human vein wall adjacent to indwelling central venous catheters. J Vasc Interv Radiol. 2003 Sep;14(9 Pt 1):1163-8. doi: 10.1097/01.rvi.0000086531.86489.4c.

  PMID: 14514808 BACKGROUND

• Wichmann D, Heinemann A, Zahler S, Vogel H, Hopker W, Puschel K, Kluge S. Prospective study of device-related complications in intensive care unit detected by virtual autopsy. Br J Anaesth. 2018 Jun;120(6):1229-1236. doi: 10.1016/j.bja.2018.02.031. Epub 2018 Apr 4.

  PMID: 29793590 BACKGROUND

• Rockholt MM, Naddi L, Badri AM, Englund E, Kander T. Macro- and microscopic changes in veins with short-term central venous catheters: an observational autopsy study. BMC Anesthesiol. 2024 Jan 2;24(1):5. doi: 10.1186/s12871-023-02380-x.

  PMID: 38166620 BACKGROUND

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis; Thrombosis

Interventions

Contrast Media

Condition Hierarchy (Ancestors)

Venous Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Thomas Kander

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Kander, PhD

CONTACT

+4646171163; thomas.kander@med.lu.se

Emilia Ängeby Eriksson, MD

CONTACT

+4646175155; emilia.angeby@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor investigator

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: January 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After the publication of the study up to 3 years after the publication of the study
• Access Criteria: Researchers may submit requests through the specified channel, detailing the purpose and proposed analyses. Approved applicants will sign a data access agreement, ensuring responsible and transparent use of the data.

Locations

SE (1)