相关临床试验
19
4 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
2
10.5%
已完成
10
52.6%
尚未招募
2
10.5%
招募中
2
10.5%
终止
2
10.5%
撤回
1
5.3%
暂无批准数据
- Cerus Corporation received an additional $7.2 million contract amendment from the U.S. Department of Defense to develop lyophilized INTERCEPT Fibrinogen Complex for treating trauma-related bleeding. - The funding will support CRYO-FIRST, a 320-patient randomized study comparing pre-thawed IFC to conventional cryoprecipitated antihemophilic factor in trauma-associated hemorrhagic shock patients. - This award adds to approximately $18 million already provided under Cerus' DoD contract to develop room-temperature, shelf-stable fibrinogen products for military and civilian trauma care. - Initial patient enrollment for the CRYO-FIRST study is targeted for the first half of 2026, with the goal of improving early fibrinogen treatment in trauma patients.
- Cerus Corporation will present positive Phase 3 ReCePI study results for its INTERCEPT Blood System red blood cell treatment at the 35th ISBT Congress in Milan. - The presentations demonstrate broad clinical applicability of the INTERCEPT system across multiple blood components including platelets, plasma, and red blood cells. - Clinical data showcases reduced hemoglobin use in complex cardiac surgery and effective pathogen inactivation capabilities including California encephalitis virus. - The INTERCEPT system represents the only FDA-approved pathogen reduction technology for platelets and plasma globally.
- Cerus Corporation has received CE mark approval for its INT200, a next-generation LED-based illumination device for the INTERCEPT Blood System, enabling commercialization throughout the European Union. - The new INT200 device maintains compatibility with existing processing sets while offering enhanced physical design and improved user interface, providing blood centers with a more robust pathogen inactivation platform. - This regulatory milestone completes the authorization of the INTERCEPT Blood System for platelets and plasma under the EU Medical Device Regulation framework.
- Cerus Corporation presented data at the AABB Annual Meeting showcasing the benefits of INTERCEPT-treated blood products. - The ReCePI Phase 3 trial results indicated acute kidney injury outcomes following amustaline/glutathione pathogen-reduced red cells in cardiac surgery. - Studies highlighted the efficiency of INTERCEPT Fibrinogen Complex compared to traditional cryoprecipitate in laboratory settings. - Further research explored the implementation and impact of pathogen-reduced cryoprecipitate in managing postpartum hemorrhage and reducing operative transfusions.
- A prospective, cluster-randomized trial is underway to compare pathogen-reduced cryoprecipitate (IFC) with conventional cryoprecipitated AHF in cardiac surgery patients. - The primary goal is to assess whether IFC reduces the total number of non-cryo AHF/IFC blood components transfused during the first 30 days post-surgery. - Secondary outcomes include the number of cryo AHF/IFC units wasted, time to transfusion, length of stay, and adverse events, providing a comprehensive effectiveness analysis. - The study uses a pragmatic design, randomizing by month to reflect real-world clinical practice and minimize disruption to blood bank operations.
