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

NCT06683157 | Recruiting DMC

• 1 other identifier: ICVT
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Embolism and Thrombosis of Calf Muscular Vein

Keywords

Isolated Calf Vein Thrombosis; ultrasound surveillance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

not drug DIAGNOSTIC_TEST

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.

Also known as: ultrasound surveillance

serial ultrasound 3

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

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stadtisches Klinikum Dresden: lead

Study Sites (1)

Städtisches Klinikum Dresden

Dresden, Saxony, 01067, Germany

RECRUITING

Central Study Contacts

Sebastian M. Schellong, Prof. Dr.

CONTACT

+493514801000; sebastian.schellong@klinikum-dresden.de

Mirko Brudzinski

CONTACT

+493514803888; mirko.brudzinski@klinikum-dresden.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. S.M. Schellong

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: November 12, 2024
• Study Start: September 18, 2017
• Primary Completion: November 14, 2024
• Study Completion: December 31, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

DE (1)