Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

AcTIVE - ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis: a randomized Trial

This research, called AcTIVE, aims to find the best emergency treatment for people who cough up blood, a condition known as hemoptysis. The study is comparing two existing medicines, tranexamic acid and terlipressin, to a simple salt water solution. We want to see how well these treatments stop the bleeding completely or reduce it significantly within three days, without needing other medical procedures like a special treatment to block blood vessels. The study will also look at how quickly people recover, if they need other treatments, how safe the medicines are, and how many people have the bleeding return within 30 days. It's for adults aged 18 and over, regardless of gender, who are experiencing hemoptysis from any cause except cystic fibrosis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

315

Start

09 Oct 2024

Hemoptysis whatever the cause with the exception of cystic fibrosis

What is this study about?

Imagine you're coughing up blood – it can be a really frightening experience. Doctors call this 'hemoptysis'. This study, named AcTIVE, is designed to help find the best emergency treatment for people who are experiencing this, no matter what's causing it (except for a specific lung condition called cystic fibrosis).

The main goal of the research is to see if two different medicines, called tranexamic acid and terlipressin, can help stop the bleeding more effectively than a simple salt water solution. The research team wants to find out which treatment helps people recover without needing other medical procedures, like a special procedure to block blood vessels. They'll be looking closely to see if the bleeding stops completely or reduces greatly within three days of starting treatment.

Ultimately, this study aims to improve the care for people who cough up blood. By comparing these treatments, the researchers hope to give doctors clearer guidance on how to best manage this emergency situation, helping patients feel better and recover faster.

Key takeaways

Study compares two medicines (tranexamic acid and terlipressin) for coughing up blood.
Aims to find which treatment stops bleeding best in an emergency.
Compares treatments to a salt water solution (a 'placebo').
Focuses on adults with hemoptysis from various causes.
Monitors how well bleeding stops within 3 days.
Looks at safety and recovery over 30 days.

Who may be eligible?

To take part in this study, you need to be an adult, at least 18 years old. Both men and women are welcome to participate.

You must be currently experiencing hemoptysis, which means coughing up blood. The cause of your hemoptysis doesn't usually matter for this study, for example, it could be due to an infection or another lung problem.

However, if you have hemoptysis because of a condition called cystic fibrosis, this particular study isn't suitable for you. The researchers are focusing on other causes of coughing up blood.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently coughing up blood?
Is your hemoptysis NOT caused by cystic fibrosis?
Are you open to receiving one of three possible treatments (two medicines or a salt water solution)?
Are you able to stay in the hospital for close monitoring if needed?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given one of three treatments: tranexamic acid, terlipressin, or a salt water solution (which acts as a comparison). You won't know which one you're receiving, and neither will your doctors, to ensure fair results. The medicines will be given to you in the hospital as part of your emergency care.

During your hospital stay, the medical team will closely monitor your condition, especially for the first three days, to see if the bleeding stops or reduces. They'll also check if you need any other procedures. You'll have regular checks by doctors and nurses, and they'll ask you about how you're feeling and any symptoms you have. We'll also be tracking your recovery for the first 30 days after you start treatment.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this study, a potential benefit is that you might receive a treatment that proves to be more effective for your condition. However, there's no guarantee it will work for everyone, and you might receive the salt water solution, which is not an active drug. There is a possibility of side effects from the medicines, which the research team will explain fully. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is hemoptysis?

Hemoptysis is the medical term for coughing up blood. It can be a scary experience, and this study aims to find better ways to treat it.

What are tranexamic acid and terlipressin?

These are medicines that doctors sometimes use to help stop bleeding. This study is comparing them to see how well they work for hemoptysis.

Will I know which treatment I'm getting?

No, you won't know whether you're getting tranexamic acid, terlipressin, or the salt water solution. This helps the study be as fair and accurate as possible.

How long will I be in the study?

Your condition will be closely watched for the first 3 days after treatment, and your recovery will be monitored for 30 days in total.

Can I leave the study if I change my mind?

Yes, absolutely. You can decide to leave the study at any point, and it won't affect the medical care you receive.