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 study about?

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.

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.

2 pre-surgery preparation

Before surgery, preparation involves standard medical assessments to ensure readiness for the procedure.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	27.03.2022

Trial locations

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.

Investigated Diseases:

Post procedural complication

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.

Trial ID:

2024-514332-25-00

Protocol code:

ARG-01

NCT ID:

NCT05293041

Trial Phase:

Therapeutic exploratory (Phase II)

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