Natural History of Isolated Calf Vein Thrombosis - A Prospective Cohort Under Ultrasound Surveillance

The treatment of ICVT is still controversial as conflicting international guideline strategies show. Evidence suggests that propagation rates of ICVT without risk factors are low. Unless ICVT propagates to proximal veins anticoagulation can safely been withheld, thereby avoiding a bleeding risk for the patient. However, the impact of different risk factors on propagation rates is not well understood. This gap in knowledge can only be filled by a natural history study of ICVT without anticoagulation. Since patients are safe as long as no propagation occurs close ultrasound surveillance is an adequate safety umbrella for the natural history study period. In addition, it provides an objective outcome measure to define the impact of risk factors.

Study Overview

• Status: Recruiting
• Conditions: Acute Embolism and Thrombosis of Calf Muscular Vein
• Intervention / Treatment: Diagnostic test: not drug

Detailed Description

For the purpose of this study, ICVT is defined as any thrombus being present in the calf muscle veins and/or in the deep paired calf veins as long as they do not affect the confluence (trifurcation) area or the popliteal vein.

Patients presenting with symptomatic ICVT will be examined by CCUS for both legs (V1). Inclusion/exclusion criteria will be checked, and patients will be informed about the nature of the study. In case patients provide informed consent, no anticoagulation therapy is given. Compression stockings at the calf length will be prescribed for 30 days.

CCUS will be repeated on day 5±2 (V2), day 10±2 (V3), and day 30±4 (V4). If the ICVT has propagated into the trifurcation area, the popliteal vein, or into more proximal veins therapy will be implemented according to current guidelines for proximal DVT. If no propagation to proximal veins has occurred anticoagulation will be withheld further on

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Sebastian M. Schellong, Prof. Dr.; Phone Number: +493514801000; Email: sebastian.schellong@klinikum-dresden.de
• Study Contact Backup: Name: Mirko Brudzinski; Phone Number: +493514803888; Email: mirko.brudzinski@klinikum-dresden.de

Study Locations

• Germany
  • Sachsen
    • Dresden, Sachsen, Germany, 01067
      • Recruiting
      • Stadtisches Klinikum Dresden
      • Contact: Sebastian M Schellong, Prof. Dr.; Phone Number: +493514801000; Email: sebastian.schellong@klinikum-dresden.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with symptomatic ICVT will be examined by CCUS for both legs. Inclusion/exclusion criteria will be checked. No anticoagulation therapy is given.

Description

Inclusion Criteria:

• Presence of symptomatic ICVT proven by CCUS
• Absence of proximal DVT or PE
• Age of 18 or older
• Outpatient and inpatient status
• Written informed consent

Exclusion Criteria:

• Bedridden patients
• Prior unprovoked VTE
• Active malignancy (diagnosis within the last 6 months, and/or incomplete resection, and/or ongoing radiotherapy or chemotherapy, and/or metastatic disease).
• Pregnancy
• Therapeutic anticoagulation therapy for reasons other than VTE

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

serial ultrasound 3; CCUS will be repeated on day 5±2 , day 10±2 and day 30±4. If the ICVT has propagated into the trifurcation area, the popliteal vein, or into more proximal veins therapy will be implemented according to current guidelines for proximal DVT. If no propagation to proximal veins has occurred anticoagulation will be withheld further on.

Diagnostic test: not drug; Patients presenting with symptomatic ICVT will be examined by CCUS for both legs. Inclusion/exclusion criteria will be checked. No anticoagulation therapy is given. Compression stockings at the calf length will be prescribed for 30 days. CCUS will be repeated on day 5±2, day 10±2, and day 30±4. If the ICVT has propagated into the trifurcation area, the popliteal vein, or into more proximal veins therapy will be implemented according to current guidelines for proximal DVT. If no propagation to proximal veins has occurred anticoagulation will be withheld further on.; Other Names: ultrasound surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of proximal extension of DVT and / or pulmonary embolism, symptomatic or asymptomatic DVT	Proximal DVT has to be documented by CCUS as a new thrombus in the trifurcation area, the popliteal vein, or in more proximal deep veins. Non-fatal PE has to be documented as an intraluminal filling defect in CT pulmonary angiography, as an unequivocal perfusion defect in lung scintigraphy, preferably performed in SPECT technique, or, in case of hemodynamic compromise, by echocardiographic signs of right ventricular failure and/or direct thrombus visualization.	Day 30

Collaborators and Investigators

• Sponsor: Stadtisches Klinikum Dresden

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): November 14, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Isolated Calf Vein Thrombosis; ultrasound surveillance
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Thrombosis; Venous Thrombosis; Embolism; Embolism and Thrombosis
• Other Study ID Numbers: ICVT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No