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Study on Argipressin and Sodium Chloride to Reduce Blood Loss in Liver Surgery for Patients with Liver Cancer or Tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients undergoing surgery to remove part of the liver, a procedure known as hepatic resection. This surgery may be necessary due to conditions such as primary liver cancer, liver metastasis, or benign liver tumors. The study is investigating the effects of a medication called Argipressin on reducing blood loss during this type of surgery. Argipressin, also known as arginine vasopressin, is a solution given through an intravenous infusion, which means it is administered directly into the bloodstream.

The purpose of the study is to determine if using Argipressin during liver surgery can help reduce the amount of blood lost compared to a placebo. Participants in the study will receive either Argipressin or a placebo during their surgery. The study is designed to be double-blinded, meaning neither the participants nor the medical staff will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, various health indicators will be monitored, including blood loss during surgery, the need for blood transfusions, and levels of certain blood components and proteins. The study will also track the participants' recovery, including their hospital stay and any complications that may arise after surgery. The trial aims to provide valuable information on whether Argipressin can be an effective treatment to minimize blood loss during liver surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after signing an informed consent form. Eligibility includes being 18 years or older, scheduled for liver surgery, and classified as ASA class I-III.
Step 2
Pre-surgery preparation
Before surgery, preparation involves standard medical assessments to ensure readiness for the procedure.
Step 3
Surgery and medication administration
During liver surgery, an infusion of argipressin or a placebo is administered intravenously. The goal is to assess the effect on blood loss.
The medication used is Empressin (40 IE/2 ml) as a solution for infusion. Sodium chloride is also used as a solution for injection.
Step 4
Immediate post-surgery monitoring
Blood loss is measured at the end of surgery. Blood transfusion needs are assessed immediately and on postoperative days 1, 2, or 5.
Various blood levels, including white blood cells and proteins, are monitored from the end of surgery through postoperative day 5.
Step 5
Extended post-surgery monitoring
Additional tests include monitoring of inflammatory markers and kidney function on specific postoperative days.
Heart function and blood pressure are assessed at the end of surgery and on postoperative day 1.
Step 6
Hospital stay and recovery
The length of hospital stay and any complications are documented up to 30 days after surgery.

Who can join the trial?

4 criteria

The participant must be scheduled for a **hepatic resection**, which is a surgery to remove part of the liver. This can be done through an open surgery or a laparoscopic surgery, which is a less invasive method using small cuts.
The participant must be **18 years old or older**.
The participant must be classified as **American Society of Anaesthesiologists (ASA) class I-III**. This is a system used by doctors to assess the fitness of patients before surgery. Class I means a healthy patient, Class II means a patient with mild systemic disease, and Class III means a patient with severe systemic disease.
The participant must have signed an **informed consent form**, which means they have been informed about the study and agree to participate.

Who cannot join the trial?

5 criteria

Patients who are not undergoing hepatic resection surgery. This is a surgery to remove part of the liver.
Patients who are not having the surgery due to a primary malignant disease (a type of cancer that starts in the liver), metastasis (cancer that has spread to the liver from another part of the body), or a benign tumour (a non-cancerous growth).
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not considered part of the vulnerable population selected for the study.

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Verified sites

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Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
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Gothenburg, Sweden

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Investigated drugs

Argipressin is being studied to see if it can reduce blood loss during liver surgery. It is given to patients through an infusion during the operation. The trial aims to find out if using Argipressin can help control bleeding better than not using it.

What is already known about the treatment

Argipressin – Argipressin is administered intravenously, typically during surgical procedures. It is currently being studied in clinical trials to assess its effectiveness in reducing blood loss during liver resection surgeries. The main therapeutic indication for Argipressin in this context is to manage blood loss in patients undergoing hepatic resection due to primary malignant disease, metastasis, or benign tumors. At the molecular level, Argipressin works by constricting blood vessels, which helps to reduce bleeding. It is classified pharmacologically as a vasopressin analog, which is a type of medication that mimics the action of the natural hormone vasopressin.

Investigated diseases

Primary Malignant Liver Disease
This condition involves the growth of cancerous cells originating in the liver. It typically progresses as these malignant cells multiply and form tumors, potentially affecting liver function. Over time, the cancer may spread to other parts of the body, a process known as metastasis. Symptoms can include jaundice, abdominal pain, and weight loss. The progression can vary greatly depending on the type and stage of the cancer.
Liver Metastasis
This occurs when cancer cells spread to the liver from another part of the body. The progression involves the growth of secondary tumors in the liver, which can impair its function. Symptoms may include fatigue, abdominal swelling, and jaundice. The rate of progression can depend on the primary cancer's type and how aggressively it spreads.
Benign Liver Tumor
These are non-cancerous growths in the liver that generally do not spread to other parts of the body. They often grow slowly and may not cause symptoms unless they become large. In some cases, they can cause discomfort or pain in the abdomen. The progression is usually stable, but monitoring is often recommended to ensure they do not cause complications.