Impact of COVID-19 After Autologous Hematopoietic Stem Cell Transplantation in Sweden
- Conditions
- Stem Cell Transplant ComplicationsMyeloma MultipleHematologic NeoplasmsMalignant LymphomaCovid19
- Interventions
- Other: Autologous stem cell transplantation
- Registration Number
- NCT04760184
- Lead Sponsor
- Uppsala University
- Brief Summary
This retrospective observational cohort study aims to describe the impact of COVID-19 in patients treated with autologous stem cell transplantation (ASCT) for malignant disease in terms of risk factors, morbidity, need for supportive care and mortality. All patients treated with ASCT in Sweden from 1st January 2020 until 31st December 2020 are eligible for this study. Patients who also has tested positive for SARS-CoV-2 from start of conditioning or later will be identified through the national registry of the Public Health Agency of Sweden and a systematic analysis of their medical records will be performed.
- Detailed Description
Research question How does infection with SARS-CoV-2 affect patients with hematological malignancies who are treated with autologous hematopoietic stem cell transplantation?
Study population All Swedish citizens treated with ASCT for malignant disease in Sweden from 1st January 2020 until 31st December 2020 are eligible for this study. There will be a minimum follow-up time of one month for all patients.
Data collection and storage Patients will be identified using local ASCT registers at the seven university hospitals, as there is no national register for ASCT-patients in Sweden. These seven university hospitals are the only sights to perform ASCT in Sweden. The Public Health Agency of Sweden (Folkhälsomyndigheten - FHM) has the national responsibility to surveil and control communicable disease. The FHM uses several different surveillance systems to monitor the spread of COVID-19. Since COVID-19 is subject to mandatory reporting under the Communicable Diseases Act, physicians and laboratories continuously supply data to be analyzed daily by the FHM. The coverage of this database is estimated to be very high, close to 100%. For this study the investigators will link the patients identified through the ASCT-centers with the register of SARS-Cov-2 positive patients (SmiNet) held by the FHM. Patients who has tested positive for SARS-CoV-2 on the day of start of conditioning or at any given time thereafter will be included in the study. Inclusion of positive SARS-CoV-2 tests will start from 1st January 2020 until 31st March 2021 to allow for 3 months of follow-up after transplantation. For every ASCT-patient that has tested positive for COVID-19 after ASCT a systematic analysis of their medical records will be performed to describe the circumstances, impact and outcome of the COVID-19.
All data collected will be stored in a deidentified data set on a secure server held by Dalarna Country Council where name and social security number have been erased and given a coded study number. Each patient will only be identified using a separately stored code key. All storage, correspondence and analysis with the code key and pseudonymized data set will adhere to current European General Data Protection Regulation (GDPR) guidelines. The code key will be destroyed as soon as data collection is completed, data quality is secured and the final report is published. The data set will be stored for 10 years and then be destroyed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Diagnosis of hematological cancer (C81-C96 according to the International Classification of Diseases 10th revision (ICD-10).
- Autologous hematopoietic stem cell transplantation performed 1 January 2020 until 31st December 2020 at a Swedish transplantation center.
- Positive RT-PCR test for SARS-CoV-2 performed in Sweden
- Age below 18 years and 0 months at the time of transplantation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID19 positives after autologous stem cell transplantation Autologous stem cell transplantation All Swedish citizens treated with ASCT for malignant disease in Sweden from 1st January 2020 until 31st December 2020 who has tested positive for SARS-CoV-2 from start of conditioning until the end of the study period 31st March 2021.
- Primary Outcome Measures
Name Time Method Overall survival 90 days Overall survival after infection with COVID-19
COVID-19 related mortality within 6 months after infection As classified by the WHO; a death resulting from a clinically compatible illness in a confirmed COVID-19 case, unless there is a clear alternative cause of death that cannot be related to COVID disease (e.g., trauma). There should be no period of complete recovery between the illness and death
- Secondary Outcome Measures
Name Time Method Occurence of venous thrombosis Up to 15 months Event of venous thrombosis
Occurence of cytokine release syndrome Up to 15 months Event of cytokine release syndrome
Time of COVID-19 infection Up to 15 months Time of SARS-CoV-2 infection in relation to autologous stem cell transplantation
Occurence of ARDS Up to 15 months Diagnosis of Acute respiratory distress syndrome (ARDS)
Occurence of arrhythmias Up to 15 months Event of recorded arrhythmias
Occurence of acute cardiac injury Up to 15 months Event of acute cardiac injury
Non-invasive ventilation Up to 15 months Duration of non-invasive ventilation (NIV)
Intensive care Up to 15 months Duration of care in intensive care unit
ECMO Up to 15 months Duration of extracorporeal membrane oxygenation (ECMO)
Previous disease modifying treatment Prior to autologous stem cell transplantation Description of previous disease modifying treatment prior to autologous stem cell transplantation
Elevated leukocyte count At autologous stem cell transplantation or up to 15 months Event of elevated leukocyte count at diagnosis of COVID-19
Hospitalization Up to 15 months Duration of hospitalization
Oxygen treatment Up to 15 months Duration of oxygen treatment
High-flow oxygen therapy Up to 15 months Duration of high-flow oxygen therapy
Invasive mechanical ventilation Up to 15 months Duration of Invasive mechanical ventilation
Occurence of arterial thrombosis Up to 15 months Event of arterial thrombosis
Comorbidities Prior to autologous stem cell transplantation Description of comorbidities prior to autologous stem cell transplantation
Elevated troponin At autologous stem cell transplantation or up to 15 months Event of elevated troponin at diagnosis of COVID-19
Occurence of secondary infection Up to 15 months Event of any secondary infection
Conditioning treatment At autologous stem cell transplantation Description of conditioning treatment prior to autologous stem cell transplantation
Time of infection At autologous stem cell transplantation or up to 15 months Time of COVID-19 in relation to autologous stem cell transplantation
Elevated CRP At autologous stem cell transplantation or up to 15 months Event of elevated C-reactive protein (CRP) at diagnosis of COVID-19
Disease status Prior to autologous stem cell transplantation Description of disease status prior to autologous stem cell transplantation
Neutropenia At autologous stem cell transplantation or up to 15 months Event of neutropenia at diagnosis of COVID-19
Lymphocytopenia At autologous stem cell transplantation or up to 15 months Event of lymphocytopenia at diagnosis of COVID-19
Elevated lactate dehydrogenase At autologous stem cell transplantation or up to 15 months Event of elevated lactate dehydrogenase at diagnosis of COVID-19
Elevated ferritin At autologous stem cell transplantation or up to 15 months Event of elevated ferritin at diagnosis of COVID-19
Prolonged aPTT At autologous stem cell transplantation or up to 15 months Event of prolonged activated partial thromboplastin time (aPTT) at diagnosis of COVID-19
Elevated liver enzymes At autologous stem cell transplantation or up to 15 months Event of elevated liver enzymes at diagnosis of COVID-19
Elevated d-dimer At autologous stem cell transplantation or up to 15 months Event of elevated d-dimer at diagnosis of COVID-19
Elevated creatinine At autologous stem cell transplantation or up to 15 months Event of elevated creatinine at diagnosis of COVID-19
Trial Locations
- Locations (1)
Uppsala Universitet
🇸🇪Uppsala, Sweden