Murnau Am Staffelsee

This research aims to evaluate the effects of TAK-330 compared to standard four-factor prothrombin complex concentrate 4F-PCC in adults treated with Factor Xa inhibitors who need urgent surgery or invasive procedures. The study focuses on reversing anticoagulation caused by Factor Xa inhibitors and is a Phase 3, randomized, triple-blind trial sponsored by Takeda. Participants will be randomly assigned to receive either TAK-330 or the standard 4F-PCC. TAK-330 is given as a single intravenous infusion dose of 25 IUkg before surgery, with an optional additional 25 IUkg dose during surgery if needed, not exceeding a total of 50 IUkg or 5,000 IU. The standard 4F-PCC dose and infusion speed follow local protocols, with an additional dose allowed during surgery under the same maximum limits. These treatments are administered during hospitalization prior to surgery. During the study, participants will be hospitalized for the surgery and treatment administration, with assessments of hemostasis effectiveness at surgery end and 24 hours after treatment. Researchers will monitor blood product use, adverse events including thrombotic events, and participant survival up to 30 days after surgery. Follow-up will also include contact via telehealth or phone 30 days post-surgery to evaluate safety and outcomes. Total participation duration covers the hospital stay and the 30-day post-surgery monitoring period.

Researchers are evaluating the safety, tolerability, and pharmacokinetics of NG004, a human monoclonal antibody administered intrathecally, in patients with acute incomplete cervical spinal cord injury SCI. This first-in-human, multicenter, open-label trial aims to determine the maximum tolerated dose of NG004 through multiple ascending doses. The study focuses on individuals with acute cervical SCI classified as ASIA impairment scale C-D, within 4 to 28 days after injury. Participants will receive repeated intrathecal injections of NG004 across four different dose regimens. The trial does not include a placebo group and involves sequential dosing to assess safety and drug behavior in the body. Treatment monitoring will continue up to 6 months after the last injection to measure drug levels and half-life. Throughout the study, participants will be closely observed for adverse events, serious adverse events, and reactions related to NG004 starting from treatment initiation up to 6 months. Blood samples will be taken at specific times after injections to analyze drug concentration and how long it stays in the bloodstream. The trial will include patients aged 18 to 70 years who are hemodynamically stable and do not require full mechanical ventilation. The total study duration for each participant extends through the treatment and follow-up periods.

Researchers are conducting a multicentre phase III clinical trial involving adults and adolescents aged 12 years and older who have severe burns. The study aims to confirm the effectiveness and function of denovoSkin, an autologous dermo-epidermal skin substitute, in achieving wound closure and reducing scarring for patients with deep partial and full-thickness burns compared to the standard treatment of split-thickness skin grafts. Participants receive either the experimental treatment with denovoSkin applied to one burn area or the standard split-thickness skin graft STSG applied to another area. The study uses an intra-patient randomized design where one location is treated with denovoSkin and the other with STSG, with the roles of locations A and B switched among participants. This design allows direct comparison of the two treatments in the same patient. During the trial, participants are monitored for wound closure and scar quality six months after grafting, which is the primary outcome. Secondary outcomes include assessment of graft take, epithelialization, scar contracture, and donor site healing at various time points up to 24 months post-grafting. Participants will undergo regular evaluations to measure these outcomes and ensure safety, with the study lasting until 2029.