Study on the Safety and Effectiveness of Parecoxib and Sodium Chloride for Patients Hospitalized with Spontaneous Subarachnoid Hemorrhage

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What is this study about?

This clinical trial is focused on studying the effects of a medication called parecoxib in patients who have experienced a spontaneous subarachnoid hemorrhage, which is a type of bleeding in the brain. The study aims to evaluate the safety and effectiveness of parecoxib in these patients. Parecoxib is administered as a solution for injection. Another substance used in the study is sodium chloride, which is a common salt solution used for infusion.

The purpose of the study is to determine how well parecoxib works in improving the outcomes of patients with spontaneous subarachnoid hemorrhage. Participants in the study will receive either parecoxib or a placebo, and their progress will be monitored over a period of time. The study will assess various health outcomes, including the patients’ recovery and any side effects they may experience. The study will also look at other factors such as the length of hospital stay and any complications that may arise.

Throughout the study, patients will be closely observed to ensure their safety and to gather information on how parecoxib affects their condition. The results will help determine if parecoxib can be a beneficial treatment option for people with spontaneous subarachnoid hemorrhage. The study is designed to provide valuable insights into the potential benefits and risks of using parecoxib in this specific medical condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, weight, and diagnosis of spontaneous subarachnoid hemorrhage through brain imaging techniques such as CT, DSA, or MRI.

For women capable of becoming pregnant, adherence to a reliable contraceptive method is required for the duration of the study and three months after its completion.

2 randomization and treatment allocation

Participants are randomly assigned to either the experimental group receiving parecoxib or the placebo group. This process is double-blind, meaning neither the participants nor the researchers know which group the participants are in.

3 medication administration

The experimental group receives parecoxib administered intravenously as a solution for injection. The specific dosage and frequency are determined by the study protocol.

The placebo group receives a sodium chloride solution, also administered intravenously.

4 monitoring and assessments

Participants undergo regular monitoring to assess their clinical outcomes. This includes evaluations using the modified Rankin Scale (mRS) to determine if the outcome is favorable or unfavorable.

Secondary assessments include monitoring for vasospasms, delayed ischemic neurological deficits, and other health parameters such as fever, inflammation, and pain levels.

5 follow-up evaluations

Participants are evaluated at discharge, and follow-up assessments are conducted at three and six months after the first dose. These evaluations focus on clinical outcomes, quality of life, and any serious adverse events.

Who Can Join the Study?

You must provide a signed informed consent, which means you agree to participate in the study after understanding all the details.
Your age must be between 18 and 85 years old.
Your weight must be more than 50 kilograms.
You must have a spontaneous subarachnoid hemorrhage (SAH), which is bleeding in the space around the brain, diagnosed on a brain CT scan (a type of detailed X-ray) within 48 hours of the first symptoms. This must be due to a rupture of a bulge in one of the brain’s arteries, confirmed by DSA (a special type of X-ray) or CT angiography (a scan that shows blood vessels), with a Fisher grade between 1 and 4. Alternatively, you can have a spontaneous SAH without a source found by CT angiography, DSA, or MRI (a scan that uses magnets and radio waves to create images of the body) with a Fisher grade of 3 or 4.
If you are a woman who can become pregnant, you must use a highly reliable method of birth control for 3 months after the study ends. This can include not having sex, using birth control pills or injections that stop ovulation, using a non-hormonal or hormonal intrauterine device (IUD), having your fallopian tubes blocked, or having a partner who has had a vasectomy. Men must either not have sex or use a condom during sex for 3 months after the study ends.

Who Cannot Join the Study?

Patients who have a medical condition other than spontaneous subarachnoid hemorrhage. This is a type of bleeding in the space around the brain.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
University Hospital Olomouc	Olomouc	Czechia
University Hospital Ostrava	Ostrava	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	03.03.2025

Trial locations

Investigated drugs:

Sodium Chloride

Parecoxib is a medication being tested in this clinical trial. It is used to evaluate its safety and effectiveness in patients who have experienced a spontaneous subarachnoid hemorrhage, which is a type of bleeding in the brain. The trial aims to see if parecoxib can improve the clinical outcomes of these patients, as measured by a scale that assesses their recovery and ability to function in daily life.

Investigated diseases:

Subarachnoid haemorrhage

Spontaneous Subarachnoid Hemorrhage – This condition occurs when there is bleeding in the space between the brain and the surrounding membrane, known as the subarachnoid space. It often results from a ruptured aneurysm, which is a weakened area in a blood vessel. The bleeding can lead to increased pressure on the brain, causing sudden and severe headaches, neck stiffness, and sensitivity to light. As the condition progresses, it may result in confusion, seizures, or loss of consciousness. The bleeding can also cause complications such as vasospasm, where blood vessels narrow, potentially leading to reduced blood flow to the brain. Over time, patients may experience delayed neurological deficits or require interventions to manage complications like hydrocephalus, which is an accumulation of fluid in the brain.

Trial ID:

2024-519436-17-00

Protocol code:

PAR-FNUSA-2024

NCT ID:

NCT06579274

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Parecoxib and Sodium Chloride for Patients Hospitalized with Spontaneous Subarachnoid Hemorrhage

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?