Trollhattan

Researchers are evaluating optimized pharmacologic treatments for patients with Takotsubo Syndrome, a condition often referred to as broken heart syndrome. This large randomized registry clinical trial aims to include 1000 participants registered in SWEDEHEART to better document effective treatments, as current data from large patient groups are lacking. The trial is a Phase 4 study sponsored by Vastra Gotaland Region and is designed as an open-label, multinational, multicenter trial. Participants are randomly assigned to different treatment groups. One group receives an adenosine infusion for 3 hours followed by oral dipyridamole twice daily until left ventricular function normalizes or up to about one month. Another group receives usual care per European Society of Cardiology recommendations. A separate randomization compares oral apixaban twice daily until normalization of heart function or about one month versus no anticoagulant therapy. The study monitors heart function with echocardiographic assessments at 48-96 hours and possibly later. During the study, participants undergo regular heart ultrasounds to assess wall motion and ejection fraction, along with monitoring for events such as death, cardiac arrest, heart failure, thromboembolic events, and bleeding. The trial collects data up to 30 days after treatment begins. Researchers also track heart rhythm problems and use standardized scoring to evaluate heart muscle movement. Safety and treatment outcomes are closely observed throughout the study period, which lasts until December 2028.

Researchers are studying patients who experience out-of-hospital cardiac arrest OHCA with ventricular fibrillation VF or ventricular tachycardia VT that do not respond to initial defibrillation. The study aims to evaluate whether using double sequential defibrillation DSD earlier, after the first failed standard defibrillation, can improve 30-day survival compared to continuing with standard defibrillation. This trial addresses important gaps in knowledge about optimal defibrillation strategies to increase survival in this critical condition. The trial compares two treatment groups one using early double sequential defibrillation, where a second defibrillator with pads placed in the anterior-posterior position is applied as soon as possible, delivering rapid sequential shocks from two devices and the other continuing with standard single defibrillation using one defibrillator with anterior-lateral pad placement. Both groups receive resuscitation until return of spontaneous circulation, resuscitation is stopped, or the patient is transported to the hospital. The study is randomized and open-label, involving ambulance units equipped with two study-specific defibrillators. Participants are adult OHCA patients with an initial shockable rhythm and at least one failed standard defibrillation. During the study, ambulance teams perform screening, randomization, treatment according to assigned group, and initial follow-up. The main outcome measured is survival at 30 days. Secondary outcomes include return of spontaneous circulation, survival to hospital admission and discharge, and neurological function at discharge. The study will continue monitoring these outcomes to assess the effectiveness of early DSD compared to standard defibrillation strategies.

Researchers are studying adults with Fontan circulation, a condition where the heart has a single ventricle pumping blood. This research aims to understand how this circulation affects reproductive health, fertility, pregnancy outcomes, parenthood experiences, fatigue, and cognitive functions. The study includes about 200 adults and their partners from Sweden and seeks to improve medical and psychosocial care for people living with complex congenital heart defects. Participants will provide data through questionnaires and functional tests. The study includes different groups males and females with Fontan circulation, their partners, and control groups without congenital heart disease. The study collects information on sexual dysfunction, infertility, pregnancy outcomes, delivery choices, complications, parenthood perceptions, fatigue, and cognitive abilities such as memory, attention, and executive functions. Participants will engage in data collection including medical records, obstetrical history, and responses to questionnaires. The study measures primary outcomes like sexual dysfunction and infertility prevalence, and secondary outcomes such as obstetric and cardiological variables, parenthood experiences, and cognitive function. The research involves multiple national centers in Sweden and aims to provide detailed insights over several hours of assessment and follow-up, enhancing care for adults living with Fontan circulation.

This research aims to determine if hip replacement surgery arthroplasty can reduce the need for additional operations compared to internal fixation in elderly patients with an undisplaced femoral neck fracture. Patients aged 75 years and older with this type of fracture will be included and randomly assigned to one of two treatments through the Swedish Fracture Register platform. The study focuses on combining reoperation rates and mortality into a single main outcome measure to evaluate which treatment offers better results. Participants will receive either arthroplasty, which may be hemi or total hip replacement depending on the patients condition and surgeons decision, or internal fixation using screws, pins, or a sliding hip screw device based on hospital routine. The study is a randomized controlled trial without blinding, comparing these two device-based treatments for hip fractures in elderly patients. During the study, researchers will monitor the combined rate of reoperations and mortality for 1 to 2 years after surgery. Additional outcomes include reoperation rates, short- and long-term mortality, and patient-reported physical function one year after surgery. Participants will be followed up to assess these outcomes, with care taken to track their progress and safety over the study period.

Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.

Preterm preeclampsia is a severe condition affecting both mother and baby, often requiring early delivery that leads to high rates of newborn complications and death. This trial investigates if metformin, a drug commonly used for diabetes, can help delay delivery, improve newborn weight, and reduce time spent in neonatal care in women with preterm preeclampsia in Nordic countries. The study builds on previous research suggesting metformin may modify the disease and improve outcomes. Participants will be randomly assigned to receive either metformin extended release ER tablets or placebo tablets taken orally three times daily. The dose starts at 500 mg three times a day and may increase to 1 gram three times daily as tolerated. Treatment continues until delivery, and dose adjustments may be made if side effects occur. The study is triple-blind, meaning neither participants nor researchers know who receives metformin or placebo. During the study, participants will keep a diary to record tablet intake, and their routine care for preeclampsia will continue without interference. Researchers will measure the length of pregnancy from randomization to delivery, newborn weight at birth, and the duration of neonatal care. Follow-up assessments of mothers and children will occur two years after birth. The study aims to improve outcomes while monitoring safety and treatment adherence.

Researchers are evaluating the safety of performing surgery on the parotid gland, which is the large salivary gland in front of the ear, without using a wound drain. This study aims to determine if skipping the drain, which is currently standard practice in Sweden and often requires an overnight hospital stay, is just as safe. The goal is to see if avoiding the drain can allow more patients to go home the same day and improve patients quality of life while also being cost-effective for healthcare. Participants will be randomly assigned to one of two groups during their surgery one group will receive the standard treatment with a wound drain placed to remove excess fluid, while the other group will have the surgery without a wound drain. Apart from this difference, all participants will receive the same surgical care. The surgical site will be closed using standard techniques, and postoperative monitoring will follow routine protocols. During the study, researchers will monitor the healing process and collect information on complications such as fluid build-up, bleeding, or infections, up to seven weeks after surgery. Participants will complete questionnaires about their health and symptoms at one week and six months post-surgery. Additional assessments will include facial nerve function, incidence of Freys syndrome, quality of life measurements, hospital stay length, and symptom-specific outcomes. The total study follow-up extends up to six months to evaluate both safety and patient well-being.

Researchers are conducting a prospective observational study to understand the long-term management of propionic aciduria PA and methylmalonic aciduria MMA using maintenance therapy with carglumic acid NCG. This study collects detailed data on treatment characteristics, clinical outcomes, and healthcare use among patients who have been treated with carglumic acid for more than six months. Additionally, qualitative interviews with adult patients and caregivers gather insights about the disease and treatment burden. The study includes up to 85 patients diagnosed with MMA or PA from several European countries who have used carglumic acid for at least six months. Data is collected at baseline, 12, 18, 36, and 54 months to track changes over time. Participants or their caregivers may also take part in one-on-one phone interviews to discuss symptoms, treatment experiences, preferences, and satisfaction. During the study, researchers review medical charts and record demographic and treatment history information through a web-based system. The interviews are audio-recorded, transcribed, and analyzed to identify patient experiences and treatment impacts. The main outcome measured is the change in the number and duration of metabolic decompensation events over 54 months, along with secondary outcomes like healthcare use, caregiver burden, satisfaction, and maintenance dosage. Participants remain involved for up to 54 months with ongoing data collection and interviews.

Researchers are evaluating a Scandinavian decision support tool designed to help manage children with mild and moderate head injuries who seek care in emergency departments. The study focuses on whether these guidelines can reliably identify children with important complications, such as bleeding in or around the brain, following head trauma. This is a prospective, multicenter observational study including hospitals in Sweden and Norway that routinely treat children with traumatic brain injuries. The study involves no changes to usual care all children receive standard management regardless of participation. Data is collected on patient history, symptoms, and treatment during the emergency visit and entered into electronic case report forms. Follow-up is conducted through medical records and electronic questionnaires sent to guardians at 1, 3, and 4 months after injury, with long-term outcomes assessed beyond 6 months. A sub-study will also explore blood and saliva biomarkers to predict brain injury in certain cases. Participants will be monitored through clinical examinations, CT scan results, and questionnaires about recovery. The study measures outcomes like clinically important brain injury within one week, need for neurosurgery, CT findings, hospital admission, and time to full recovery. Safety and long-term effects are followed for up to four years. Data is analyzed to assess how well the Scandinavian and other international guidelines predict outcomes for children with head trauma.