Fibrinogen in Liver Transplant Subjects (FITS)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Amount of blood products (24-hours) [Time Frame: 24-hours after initial blood product administration]
研究概览
简要总结
The study is a prospective, multi-centered, unblinded, randomized controlled pilot study. The primary objective is to compare functional hemostatic capacity of two approved products Intercept Fibrinogen Complex (IFC) to Standard Cryoprecipitate Antihemophilic Factor (AHF) for liver transplant patients with bleeding and hypofibrinogenemia to determine impact of earlier access to a concentrated source of fibrinogen in a goal-directed manner.
详细描述
Fibrinogen is an important factor for hemostasis and when it is deficient or dysfunctional replacing it will improve hemostasis and reduce bleeding. Observational data indicates the use of cryoprecipitate as a source of fibrinogen may reduce bleeding and improve outcomes in patients with severe bleeding. Liver transplant patients often become hypofibrinogenemic and may benefit from early goal directed use of cryoprecipitate or IFC. IFC can be more readily available since it can be stored at room temperature compared to cryoprecipitate which requires thawing. As a result, IFC can be immediately available when indicated compared to the delay in administration of cryoprecipitate due to the need for it to be thawed. This trial will compare clinical outcomes for subjects randomized to either cryoprecipitate or IFC in bleeding liver transplant patients with reduced fibrinogen function.
There is no data comparing outcomes for subjects receiving IFC or cryoprecipitate in any patient population.
The rationale for this trial is to compare IFC to cryoprecipitate (cryo) to assist with the design of a future definitive multicenter trial. Potential advantages of IFC are that since it is stored at room temperature it can be made immediately available whereas with cryo the delay in treatment can be 30 to 40 min due to the need to thaw it from a frozen state. The reduced time to treatment of bleeding may improve outcomes with the use of IFC compared to cryo. In vitro data indicates similar hemostatic function between IFC and Cryo. IFC is pathogen reduced cryoprecipitate. The pathogen reduction methods are licensed for IFC and there has been no safety concerns regarding its use at the centers that are currently using it as their standard product (unpublished).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
N/A unblinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Scheduled to undergo cadaveric liver transplant
- •Meets at least one of the following criteria:
- •Baseline fibrinogen <200 mg/dL or clinically significant visoelastic testing,
- •Alcoholic cirrhosis,
- •Nonalcoholic Steatohepatitis (NASH),
- •HCV infection
排除标准
- •Living related donor transplant,
- •Known prothrombotic disorder,
- •Patient objection to blood transfusion,
- •Known severe allergic reaction to plasma-based products,
- •IgA deficiency with known hypersensitivity reaction to plasma,
- •Hepatocellular/cholangio carcinoma,
- •Primary biliary fibrosis
研究组 & 干预措施
Standard Antihemophilic Factor (AHF)
AHF is the standard of care fibrinogen product often used in liver transplant cases. The procedures to use AHF include requesting the order of this product and then waiting for the product to be thawed for use, which can take approximately 10-15 minutes. Subjects assigned to this group will receive all standard of care procedures, including the use of AHF if required during their scheduled surgery.
干预措施: Cryoprecipitate Antihemophilic Factor (AHF) (Biological)
Intercept Fibrinogen Complex (IFC)
IFC is an approved fibrinogen product that is not typically stored in the OR for liver transplant cases. Subjects assigned to this group will receive standard of care procedures, with the addition of IFC being readily available in their designated OR to eliminate any delay if they are to require the use of a fibrinogen product.
干预措施: Intercept Fibrinogen Complex (IFC) (Biological)
结局指标
主要结局
Amount of blood products (24-hours) [Time Frame: 24-hours after initial blood product administration]
时间窗: 24-hour
The amount of blood products (mL) administered will be collected at the 24-hour timepoint per intervention group and reported as the mean (mL).
次要结局
- Change in Visoelastic parameters [Time Frame: pre-intervention through 24 hours post intervention](pre intervention through 24 hours post intervention)
- Costs of blood products [Time Frame: 24 hours](24 hours post-surgery)
- Costs of IV hemostatic agents [Time Frame: 24 hours](24 hours post-surgery)