Central Venous Catheter-Related Thrombosis in Critically Ill Patients

NCT06573112 | Completed

• 1 other identifier: #3299
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to identify catheter-related thrombosis (CRT) and determine its incidence, associated factors, and outcomes. The eligible patients will undergo daily ultrasound just distal to the central venous catheter insertion site for CRT. A staff radiologist will review all positive cases. These cases will be monitored by daily ultrasound examination till three days after the removal of the catheter or till the patient stays in the intensive care unit (ICU). The patient demographics, ICU treatment details, and outcomes will be noted. The data will be then analyzed. A preventive strategy will be prepared and disseminated to the department personnel to improve the quality of care.

Conditions

Catheter Related Complication

Keywords

central venous catheter thrombosis; incidence; complications; length of stay

Outcome Measures

Primary Outcomes (1)

• Incidence of Catheter-related thrombosis (CRT)

  Incidence of CRT in critically ill patients

  one year approximately

Secondary Outcomes (4)

• Rate of cases developing ischemic complications

  one year approximately

• Presence of factors associated with the development of CRT

  one year approximately

• Mortality at 28 and 90 days

  one year approximately

• Length of stay in ICU

  one year approximately

Study Arms (1)

Cetral venous catheter group

ICU patients with a new central venous catheter.

Diagnostic Test: ultrasound assessment for catheter-related thrombosis.

Interventions

ultrasound assessment for catheter-related thrombosis. DIAGNOSTIC_TEST

Patients with newly inserted central venous catheter will be assessed with vascular ultrasound for the presence of catheter-related thrombosis

Cetral venous catheter group

Eligibility Criteria

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

Study Population

All adult patients (\>18 years) admitted to the ICU who receive a new CVC placement in the ICU or just before admission to the ICU in the emergency department of the tertiary hospital specified will be considered potential candidates for the study. Once they fulfill the inclusion criteria, those whose surrogates or patients themselves consent to the study will be included in the study.

You may qualify if:

• Adult patients (\>18 years of age) undergoing Central Venous Catheter (CVC) placements in the ICU or emergency department while waiting for admission to the ICU.

You may not qualify if:

• Pre-existing deep vein thrombosis (DVT),
• Pre-existing CVC at ICU admission (other than placement in the emergency department)
• Refusal to consent.

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, Muḩāfaz̧at Masqaţ, 123, Oman

Location

Related Publications (7)

• Geerts W. Central venous catheter-related thrombosis. Hematology Am Soc Hematol Educ Program. 2014 Dec 5;2014(1):306-11. doi: 10.1182/asheducation-2014.1.306. Epub 2014 Nov 18.

  PMID: 25696870 BACKGROUND

• Evans NS, Ratchford EV. Catheter-related venous thrombosis. Vasc Med. 2018 Aug;23(4):411-413. doi: 10.1177/1358863X18779695. Epub 2018 Jun 28. No abstract available.

  PMID: 29952254 BACKGROUND

• Wu C, Zhang M, Gu W, Wang C, Zheng X, Zhang J, Zhang X, Lv S, He X, Shen X, Wei W, Wang G, Lu Y, Chen Q, Shan R, Wang L, Wu F, Shen T, Shao X, Cai J, Tao F, Cai H, Lu Q; Study Group of Central Venous Catheter-related Thrombosis. Daily point-of-care ultrasound-assessment of central venous catheter-related thrombosis in critically ill patients: a prospective multicenter study. Intensive Care Med. 2023 Apr;49(4):401-410. doi: 10.1007/s00134-023-07006-x. Epub 2023 Mar 9.

  PMID: 36892598 BACKGROUND

• Andrews K, Fitzgerald M. Cutaneous flexion reflex in human neonates: a quantitative study of threshold and stimulus-response characteristics after single and repeated stimuli. Dev Med Child Neurol. 1999 Oct;41(10):696-703. doi: 10.1017/s0012162299001425.

  PMID: 10587047 BACKGROUND

• Grant JD, Stevens SM, Woller SC, Lee EW, Kee ST, Liu DM, Lohan DG, Elliott CG. Diagnosis and management of upper extremity deep-vein thrombosis in adults. Thromb Haemost. 2012 Dec;108(6):1097-108. doi: 10.1160/TH12-05-0352. Epub 2012 Oct 23.

  PMID: 23093319 BACKGROUND

• Linenberger ML. Catheter-related thrombosis: risks, diagnosis, and management. J Natl Compr Canc Netw. 2006 Oct;4(9):889-901. doi: 10.6004/jnccn.2006.0074.

  PMID: 17020667 BACKGROUND

• Raziuddin S, Elawad ME, Benjamin B. T-cell abnormalities in antibody deficiency syndromes. Scand J Immunol. 1989 Oct;30(4):419-24. doi: 10.1111/j.1365-3083.1989.tb02445.x.

  PMID: 2814365 BACKGROUND

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Jyoti Burad, MD EDIC FICM

  Sultan Qaboos University Hospital, University Medical City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Specialist

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 27, 2024
• Study Start: July 21, 2024
• Primary Completion: March 21, 2025
• Study Completion: April 30, 2025
• Last Updated: May 18, 2025

Record last verified: 2024-08

Locations

OM (1)