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Study on the Effectiveness of Apixaban and Enoxaparin Sodium in Preventing Blood Clots in Patients with Autoimmune Hemolytic Anemia

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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 studying the effectiveness of a treatment for patients with Autoimmune Hemolytic Anemia (AIHA), a condition where the immune system mistakenly attacks and destroys red blood cells. The study aims to prevent a condition called Venous Thromboembolism (VTE), which includes blood clots in veins, by using a combination of medications. Initially, patients will receive Enoxaparin Sodium, an anticoagulant given as a subcutaneous injection, during their hospital stay. This will be followed by taking Eliquis (also known as Apixaban), an oral anticoagulant, twice daily.

The purpose of the study is to evaluate if this treatment approach can effectively prevent VTE in patients with AIHA. The study will last for a total of 24 weeks. During the first 12 weeks, patients will receive the specified medications, starting with Enoxaparin Sodium and then transitioning to Eliquis. The remaining 12 weeks will involve monitoring the patients to see if the treatment successfully prevents the occurrence of VTE.

Participants will be observed for any signs of VTE, such as deep vein thrombosis or pulmonary embolism, and any side effects from the medications. The study will also look at other health factors that might be related to the risk of developing blood clots. This research is important for understanding how to better prevent serious complications in patients with AIHA.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial hospitalization
Upon joining the study, the patient is hospitalized. During this period, the patient receives a medication called enoxaparin sodium.
The medication is administered as a subcutaneous injection at a dose of 4000 IU per day. This treatment continues throughout the hospitalization period.
Step 2
Transition to oral medication
After the hospitalization phase, the patient transitions to an oral medication regimen.
The patient takes apixaban, which is provided in the form of Eliquis 2.5 mg film-coated tablets.
The dosage is 2.5 mg taken twice daily, once in the morning and once in the evening.
Step 3
Treatment duration
The oral medication with apixaban continues for a total of 12 weeks.
The primary goal during this period is to prevent the occurrence of venous thromboembolic events, such as deep vein thrombosis or pulmonary embolism.
Step 4
Follow-up and monitoring
Throughout the 24-week study period, the patient is monitored for any signs of venous thromboembolic events.
Regular assessments are conducted to check for any adverse events, including bleeding or other complications.
Step 5
End of study
At the end of the 24-week period, the study concludes.
The final assessments are conducted to evaluate the overall effectiveness of the treatment and to document any outcomes related to the patient's health condition.

Who can join the trial?

7 criteria

Patient who has given free, written, and informed consent to participate.
Patient is **18 years or older**.
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Patient has a diagnosis of **autoimmune hemolytic anemia (AIHA)**, which is a condition where the immune system attacks and destroys red blood cells. This can be primary or secondary to other conditions like infections or blood diseases. The diagnosis is confirmed by:
- **Hemoglobin** level less than 12 grams per deciliter (g/dL). Hemoglobin is a protein in red blood cells that carries oxygen.
- **Haptoglobin** level less than 0.4 grams per liter (g/L). Haptoglobin is a protein that binds free hemoglobin in the blood.
- Positive **direct antiglobulin test** (also known as the direct Coombs test), which checks for antibodies attached to red blood cells. This test may show IgG with or without C3d.
- Patient is either newly diagnosed or has a **relapse** of AIHA. A relapse means a decrease in hemoglobin levels associated with AIHA, meeting the criteria mentioned above, and the doctor believes it is necessary to start specific treatment for AIHA.
- Patient has an estimated **life expectancy of more than 6 months**.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with **autoimmune hemolytic anemia**. This is a condition where the body's immune system mistakenly attacks and destroys its own red blood cells.
Patients who are not within the specified age range for the study. The study includes certain age groups, so those outside these groups cannot participate.
Patients who are part of a vulnerable population. This means groups of people who might need special protection or care, such as children or the elderly, are not included.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Besancon University Hospital Center
Besançon, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France

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Investigated drugs

Heparin
is a medication used to prevent blood clots. In this trial, it is given as an injection under the skin to help reduce the risk of developing blood clots during hospitalization. It is used for a short period as part of the initial treatment phase.
Apixaban
is a medication taken by mouth to prevent blood clots. In this trial, it is used after the initial treatment with heparin to continue preventing blood clots over a longer period. It helps reduce the risk of venous thromboembolism in patients with autoimmune hemolytic anemia.

What is already known about the treatment

Enoxaparin
This medication is administered subcutaneously, meaning it is injected under the skin. It is currently used in clinical trials to assess its effectiveness in preventing venous thromboembolism in patients with autoimmune hemolytic anemia. Enoxaparin is primarily indicated for preventing blood clots. It works by inhibiting certain factors in the blood clotting process, thus reducing the formation of clots. It belongs to the pharmacological class of anticoagulants, specifically low molecular weight heparins.
Apixaban
This medication is taken orally, typically in the form of a tablet. It is being studied in clinical trials for its role in preventing venous thromboembolism in patients with autoimmune hemolytic anemia. Apixaban is used to prevent blood clots and works by blocking a specific protein involved in blood clotting, thereby reducing the risk of clot formation. It is classified as an anticoagulant, specifically a direct oral anticoagulant.

Investigated diseases

Autoimmune Hemolytic Anemia – This is a condition where the immune system mistakenly attacks and destroys the body's own red blood cells, leading to a shortage of these cells. The disease can cause symptoms such as fatigue, shortness of breath, and a rapid heartbeat due to the reduced oxygen-carrying capacity of the blood. It can occur suddenly or develop gradually, and the severity of symptoms can vary widely among individuals. The condition may be triggered by infections, medications, or other autoimmune disorders. In some cases, it can lead to complications such as an enlarged spleen or liver. The disease is considered rare and can be classified into different types based on the temperature at which the antibodies are most active, such as warm-type or cold-type.