Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding

NCT04748393 | Terminated

• 1 other identifier: LUMC2017132
• Study Type: observational
• Target: 90
• Locations: 6 countries
• Sites: 7

Brief Summary

This study is an international, multicenter, academically sponsored, observational study, that focusses on fertile female patients with proven symptomatic deep vein thrombosis of the legs (DVT) or acute pulmonary embolism (PE). The incidence and severity of abnormal menstrual bleeding will be assessed for each menstrual period and correlated to quality of life. Causes of abnormal menstrual bleeding other than active anticoagulant treatment will be assessed. Treatment of abnormal menstrual bleeding (all within routine clinical care) will be evaluated for efficacy and safety.

Conditions

Venous Thromboembolism

Keywords

menorrhagia; anticoagulation

Outcome Measures

Primary Outcomes (1)

• Primary objective

  Rate of new-onset abnormal menstrual bleeding (PBAC \>100 ml), and its impact on quality of life

  3-month follow-up

Study Arms (1)

Study cohort

Consecutive female patients between the ages of 18 and 50 with child bearing potential and objectivated, symptomatic VTE, who fulfil all the inclusion criteria and meet none of the exclusion criteria, are eligible for inclusion.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: female patients within their fertile age, diagnosed with acute venous thromboembolism
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Consecutive female patients between the ages of 18 and 50 with child bearing potential and objectivated, symptomatic VTE, who fulfil all the inclusion criteria and meet none of the exclusion criteria, are eligible for inclusion.

You may qualify if:

• Ability of subject to understand the character and individual consequences of this clinical study;
• Signed and dated informed consent of the subject available before the start of any specific study procedures;
• Age ≥18 years and ≤ 50 years;
• Confirmed symptomatic first or recurrent VTE;
• DVT: incompressibility of proximal or distal veins of the affected leg by compression ultrasonography or venous filling defect on multi-detector computed tomography venography. The diagnosis of ipsilateral recurrent DVT is defined as a CUS that shows incompressibility of a different venous segment than at the reference CUS examination, or in case of a pronounced increase in vein diameter (≥4 mm) of a previous non-compressible venous segment, or by an abnormal signal of Magnetic resonance direct thrombus imaging (MRDTI);
• PE: both first and recurrent PE are diagnosed in case of at least one filling defect in the pulmonary artery tree on multi-detector computed tomography pulmonary angiography (CTPA) up to the subsegmental level, or high probability result of ventilation perfusion scintigraphy;
• Childbearing potential, i.e. with active menstrual cycle with or without hormonal regulation of any kind initiated for reasons of either contraception or for treatment of abnormal menstrual bleeding;

You may not qualify if:

• Woman between the ages of 18 and 50 who were subjected to hysterectomy or chemically induced menopause;
• Planned treatment with parenteral anticoagulation (and no switch to oral drugs);
• Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 6 months, or unwillingness to sign informed consent;
• Non-compliance or inability to adhere to the follow-up visits;
• Pregnancy or post-partum (first three months) associated VTE;
• Active in vitro fertilization (IVF) treatment or planned IVF treatment during the study period.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (7)

Medical University Hospital

Vienna, Austria

Location

Hôpital de la Cavale Blanche

Brest, France

Location

CHU Saint-Etienne

Saint-Etienne, France

Location

University Medical Centre Mannheim

Mannheim, Germany

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Geneva University Hospital

Geneva, Switzerland

Location

Guy's & St Thomas' Hospital

London, United Kingdom

Location

Related Publications (1)

• de Jong CMM, Blondon M, Ay C, Buchmuller A, Beyer-Westendorf J, Biechele J, Bertoletti L, Colombo G, Donadini MP, Hendriks SV, Jara-Palomares L, Nopp S, Ruiz-Artacho P, Stephan P, Tromeur C, Vanassche T, Westerweel PE, Klok FA. Incidence and impact of anticoagulation-associated abnormal menstrual bleeding in women after venous thromboembolism. Blood. 2022 Oct 20;140(16):1764-1773. doi: 10.1182/blood.2022017101.

  PMID: 35925686 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Menorrhagia

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• F.A. Klok

  LUMC Leiden

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: February 10, 2021
• Study Start: September 1, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

NL (1); GB (1); AU (1); CH (1); DE (1); FR (2)