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Study on the Effects of Nadroparin Calcium in Patients with Subarachnoid Hemorrhage

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What is this study about?

This clinical trial is focused on studying the effects of a medication called nadroparin calcium in patients who have experienced a subarachnoid hemorrhage, which is a type of bleeding in the brain. The study aims to determine if patients treated with a therapeutic dose of nadroparin calcium have a lower risk of death within 30 days compared to those receiving a lower, prophylactic dose. Nadroparin calcium is administered as a solution for injection under the skin.

Participants in the study will receive either a therapeutic or prophylactic dose of nadroparin calcium. The study will monitor various outcomes, including the rate of death within 30 days, as well as other potential complications such as delayed cerebral ischemia, which is a condition where the brain does not get enough blood, and venous thrombo-embolic complications, which involve blood clots. The study will also look at the occurrence of bleeding complications, the need for additional medical procedures, and the overall quality of life and cognitive functioning of the participants.

The study will continue for several months, with follow-up assessments to evaluate the participants’ health and recovery. These assessments will include checking for any new or ongoing health issues, such as hydrocephalus, which is a condition where fluid builds up in the brain, and the participants’ ability to return to their normal daily activities. The study will also use MRI scans to check for any changes in the brain, such as small areas of tissue damage, at six months after the initial treatment. The goal is to gather comprehensive data on the effectiveness and safety of nadroparin calcium in improving outcomes for patients with subarachnoid hemorrhage.

1 joining the study

Participation begins after confirmation of a subarachnoid hemorrhage (SAH) through a CT scan or lumbar puncture, with the causative aneurysm confirmed by CT-A and/or DSA.

The aneurysm must be treated with coiling within 72 hours of the initial SAH.

Informed consent is required before the first administration of the study medication.

Participants must be adults, aged 18 years or older.

2 medication administration

The study involves the administration of nadroparin calcium, a medication given as a solution for injection.

The medication is administered subcutaneously, which means it is injected under the skin.

Two dosages are used: 5,700 IU in 0.6 mL and 2,850 IU in 0.3 mL, provided in pre-filled syringes.

The objective is to evaluate whether patients treated with a therapeutic dose of low molecular weight heparin (LMWH) have a lower 30-day mortality rate compared to those treated with a prophylactic dose.

3 monitoring and evaluation

The primary endpoint is the mortality rate at 30 days.

Secondary endpoints include delayed cerebral ischemia, venous thrombo-embolic complications, hemorrhagic complications, hydrocephalus, discharge location, quality of life, cognitive functioning, clinical outcome, rate of infarctions, and mortality at six months.

Participants will undergo assessments to monitor these outcomes throughout the study duration.

4 study duration

The estimated end date for the trial is December 31, 2026.

The recruitment for the study began on February 1, 2022.

Who Can Join the Study?

  • The patient must have a subarachnoid hemorrhage (SAH), which is bleeding in the space around the brain, confirmed by a CT scan (a type of detailed X-ray) or lumbar puncture (a procedure where fluid is taken from the spine).
  • The cause of the bleeding, an aneurysm (a bulge in a blood vessel), must be confirmed by CT-A (a special CT scan that looks at blood vessels) and/or DSA (a detailed imaging test of blood vessels).
  • The aneurysm must be treated by coiling (a procedure to block the aneurysm) within 72 hours of the initial bleeding.
  • The patient must give informed consent, meaning they agree to participate after understanding the study, before receiving the study medicine.
  • The patient must be an adult, which means they are 18 years old or older.
  • Both male and female patients can participate.

Who Cannot Join the Study?

  • Patients who are not diagnosed with a subarachnoid hemorrhage. This is a type of bleeding that occurs in the space around the brain.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a clinical trial group that is not included in this study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Awclwubkb Uzq Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.02.2022

Trial locations

Investigated drugs:

Nadroparin is a medication used in this clinical trial to help improve outcomes for patients who have experienced a subarachnoid hemorrhage, which is a type of bleeding in the brain. The trial is investigating whether using nadroparin at a therapeutic dose can reduce the 30-day mortality rate compared to using it at a prophylactic dose. Nadroparin is a type of low molecular weight heparin (LMWH) that helps prevent blood clots, which can be a complication after a brain hemorrhage.

Investigated diseases:

Subarachnoid Hemorrhage – Subarachnoid hemorrhage is a condition where bleeding occurs in the space between the brain and the surrounding membrane, known as the subarachnoid space. This bleeding can lead to a sudden and severe headache, often described as a “thunderclap” headache. As the condition progresses, it may cause symptoms such as neck stiffness, nausea, vomiting, and sensitivity to light. In some cases, individuals may experience confusion, seizures, or loss of consciousness. The bleeding can increase pressure on the brain, potentially leading to further complications. It is crucial to seek immediate medical attention if subarachnoid hemorrhage is suspected.

Trial ID:
2024-511679-14-00
NCT ID:
NCT04507178
Trial Phase:
Therapeutic exploratory (Phase II)

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