Clinical Trials Logo

Clinical Trial Summary

This is a 3-phase mixed methods study design. A literature review (Phase 1) has been completed to determine the areas of exploration and to identify challenges faced and the impact of the blood disorder on pediatric patients. Based on Phase 1, Phases 2 and 3, as proposed in this study, will be completed and will include interviews of patients diagnosed with bleeding and thrombotic disorders (phase 2). The interviews will be individual, semi-structured, and consist of open-ended questions to elicit unbiased and in-depth responses to gain an understanding of participant's perspectives on themes predetermined in the study design phase.


Clinical Trial Description

The purpose of this study is to explore the experiences of pediatric patients with blood disorders, specifically thrombotic, including venous thromboembolism (VTE), and hemostatic or bleeding disorders. The information gleaned from this study will help identify specific challenges faced by patients with hemostatic and thrombotic disorders - information that is necessary to develop impactful, evidence-based solutions to support patients with hemostatic and thrombotic disorders cope with the physical, emotional, and psychological impact of blood disorders. Participants with blood disorders in this study will participate in open-ended, semi-structured interviews with a study investigator focusing on the psychosocial experiences of patients with diagnosis and treatment of their underlying disorder and the understanding of their diagnosis. Female participants additionally will be asked questions about the unique effects of heavy menstrual bleeding, either from their underlying blood disorder or secondary to anticoagulation, on similar aspects of the impact of having a blood disorder. Validated questionnaires will be completed to obtain concurrent quantitative data. The interviews will be recorded and transcribed. Participation is complete after the interview has finished; participants will continue to receive standard of care treatment during and beyond the study period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04600609
Study type Observational
Source University of Texas Southwestern Medical Center
Contact Ayesha Zia, MD
Phone 214-456-7000
Email Ayesha.Zia@utsouthwestern.edu
Status Recruiting
Phase
Start date November 9, 2020
Completion date December 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05347550 - Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients N/A
Enrolling by invitation NCT05794165 - Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism Phase 2
Completed NCT02379806 - The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study Phase 3
Recruiting NCT03691753 - Safety and Efficacy Study of Fitaya Vena Cava Filter N/A
Completed NCT02197416 - Safety of Dabigatran Etexilate in Blood Clot Prevention in Children Phase 3
Recruiting NCT05378035 - DOAC in Chinese Patients With Atrial Fibrillation
Recruiting NCT05171075 - A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE Phase 3
Completed NCT01895777 - Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE) Phase 3
Completed NCT05897697 - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Completed NCT04736719 - Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data
Completed NCT04735523 - Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
Completed NCT04736420 - Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data
Completed NCT02829957 - RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding Phase 2/Phase 3
Completed NCT02746185 - Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban Phase 3
Completed NCT02912234 - Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants Phase 1
Completed NCT02334007 - Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery Phase 1/Phase 2
Completed NCT02223260 - Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age Phase 2
Completed NCT02661568 - Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES) N/A
Completed NCT01431456 - Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery Phase 3
Completed NCT01976988 - Prospective Study on Preoperative Versus Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery Phase 3