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Double-Blind, Randomized, Placebo-Controlled, Study To Evaluate The Safety And Efficacy Of HRX215 In Participants After Major Hepatectomy, Preceded By Two Open Pilot Parts In Participants After Minor And After Major Hepatectomy Due To Colon Carcinoma Metastases
Rochester, MN
The goal of this clinical trial is to learn if HRX215 is safe, tolerable and active in adults who have undergone liver resection due to colorectal carcinoma metastases.
The objectives are:
1. to learn about the safety and tolerability of HRX215
2. to learn about how the body absorbs, distributes, and gets rid of HRX215.
3. to learn about clinical activity of HRX215
Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to investigate safety, tolerability and clinical activity in participants taking HRX215.
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The HeLiX (Hemorrhage During Liver Resection: TraneXamic Acid) Trial: Tranexamic Acid (TXA) Versus Placebo To Reduce Perioperative Blood Transfusion In Patients Undergoing Liver Resection: A Randomized Controlled Trial
Rochester, MN
The purpose of this study is to evaluate the impact of tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver resection. The rationale for this study includes: (1) experimental evidence supporting the use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons, anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient study design; and (5) the importance of the question: incidence of blood transfusion in patients undergoing liver resection is high, and the consequences serious. Participants enrolled in the prior Vanguard study will proceed directly into the RCT.
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