#1 Clinical Trials Search in Europe

Blood And Related Products

This article explores a clinical trial investigating the use of andexanet alfa, a drug designed to reverse the anticoagulation effects of factor Xa inhibitors in patients requiring urgent surgery. The study aims to assess the safety and effectiveness of andexanet alfa compared to usual care in reducing bleeding risk during surgical procedures for patients taking anticoagulants like apixaban, rivaroxaban, or edoxaban.

Table of Contents

What Are Blood and Related Products?

Blood and related products are medical treatments derived from human blood or created to mimic components of blood[1]. These products are essential in various medical situations, particularly when a patient is experiencing bleeding or requires support for their blood system.

Uses of Blood and Related Products

Blood and related products are used in a wide range of medical scenarios, including:

  • Treating blood loss during surgery or after injury
  • Managing bleeding disorders
  • Supporting patients undergoing chemotherapy
  • Helping patients with certain chronic diseases
  • Reversing the effects of blood-thinning medications (anticoagulants)

Types of Blood and Related Products

There are several types of blood and related products, each serving specific medical purposes:

  1. Whole Blood: Contains all components of blood, including red blood cells, white blood cells, platelets, and plasma.
  2. Red Blood Cells: Also known as erythrocytes, these cells carry oxygen throughout the body[1].
  3. Plasma: The liquid portion of blood that contains important proteins for clotting and immunity.
  4. Platelets: Small cell fragments crucial for blood clotting.
  5. Clotting Factors: Proteins that help in the blood clotting process. Examples include:
    • Fibrinogen: A protein that forms blood clots[1].
  6. Antifibrinolytic Agents: Medications that help prevent the breakdown of blood clots. Examples include:
    • Tranexamic acid: Helps to slow down the dissolution of blood clots[1].
    • Aminocaproic acid: Similar to tranexamic acid in its function[1].
    • Aminomethylbenzoic acid: Another medication used to control bleeding[1].
  7. Other Blood Products: This category includes various specialized products used in specific medical situations[1].

Current Clinical Trial: ANNEXA-RS

A clinical trial called ANNEXA-RS is currently being conducted to study a medication called andexanet alfa[1]. This trial is important for patients who are taking certain blood-thinning medications (specifically, Factor Xa inhibitors like apixaban, rivaroxaban, or edoxaban) and need urgent surgery.

The main goals of this study are:

  • To see if andexanet alfa can effectively control bleeding during surgery
  • To determine if andexanet alfa can quickly reverse the effects of blood-thinning medications
  • To assess if andexanet alfa can maintain this reversal effect for a certain period after surgery

This trial compares andexanet alfa to usual care methods for managing these situations. The results could potentially improve care for patients on blood thinners who need emergency surgery.

Safety and Considerations

While blood and related products are essential in many medical situations, their use comes with some considerations:

  • These products must be carefully matched to the patient to avoid adverse reactions.
  • There’s a small risk of transmitting infections, although modern screening methods have made this extremely rare.
  • Some patients may have religious or personal objections to receiving certain blood products.
  • In some cases, alternatives to blood products may be considered, depending on the specific medical situation.

Always discuss any concerns or questions about blood products with your healthcare provider. They can provide information specific to your medical situation and help you make informed decisions about your care.

Aspect Details
Study Type Phase 3 Interventional trial
Main Objective Assess andexanet’s ability to achieve effective intraoperative hemostasis compared to usual care
Key Inclusion Criteria Patients on FXa inhibitors needing urgent surgery within 12 hours, high bleeding risk
Key Exclusion Criteria Acute life-threatening bleeding, bleeding disorders, recent andexanet alfa use
Treatment Groups Andexanet alfa group vs. Usual care group
Primary Endpoint Effective intraoperative hemostasis
Secondary Endpoints Changes in anti-FXa activity at surgery start and 2 hours post-start
Follow-up Period 4 visits over approximately 30 days, with possible additional test at 120 days

FAQ

  • What is the purpose of this clinical trial? The main purpose of this trial is to evaluate if andexanet alfa is safe and effective in limiting bleeding for patients who take factor Xa inhibitors and urgently need surgery. It compares andexanet alfa to usual care in achieving effective intraoperative hemostasis (control of bleeding during surgery).
  • Who can participate in this trial? Participants must be taking a factor Xa inhibitor (like apixaban, rivaroxaban, or edoxaban), require urgent surgery within 12 hours, and have a high risk of bleeding. They must have taken the anticoagulant within 15 hours or more before the surgery. Certain exclusions apply, such as having acute life-threatening bleeding or a history of bleeding disorders.
  • How is the study conducted? The study is randomized, meaning participants are divided into two groups: one receiving andexanet alfa as an IV bolus followed by an infusion, and the other receiving usual care based on the doctor's discretion and local guidelines. The study includes the surgery period and follow-up visits over approximately 30 days.
  • What are the main outcomes being measured? The primary outcome is effective intraoperative hemostasis, which means controlling bleeding during surgery. Secondary outcomes include changes in anti-FXa activity (a measure of blood thinning) from baseline to the start of surgery and 2 hours after surgery begins.
  • Are there any long-term follow-ups in this study? Yes, there are follow-up visits over approximately 30 days after the surgery. Additionally, if a patient shows a positive anti-andexanet antibody response at day 30, they will have another antibody test about 120 days after the surgery.

Ongoing Clinical Trials on Blood And Related Products

  • Study on Andexanet Alfa for Patients on Factor Xa Inhibitors (Apixaban, Rivaroxaban, Edoxaban) Needing Urgent Surgery to Reduce Bleeding Risk

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark Estonia +13

Glossary

  • Andexanet alfa: A medication designed to reverse the anticoagulation effects of factor Xa inhibitors, potentially reducing bleeding risk in patients needing urgent surgery.
  • Factor Xa inhibitors: A class of anticoagulant medications (including apixaban, rivaroxaban, and edoxaban) that work by blocking the action of factor Xa, a key component in blood clotting.
  • Hemostasis: The process that causes bleeding to stop, or the stopping of bleeding.
  • Intraoperative: Occurring or performed during a surgical operation.
  • Anti-FXa activity: A measure of the blood-thinning effect of factor Xa inhibitors in the body.
  • IV bolus: A single, large dose of medication given intravenously (through a vein) over a short period.
  • Anticoagulation: The process of hindering blood clot formation, often achieved through medication.
  • Thrombocytopenia: A condition characterized by abnormally low levels of platelets in the blood, which can lead to increased bleeding risk.
  • Coagulopathy: A condition affecting the blood's ability to form clots, which can lead to excessive bleeding or clotting.
  • Cardiogenic shock: A serious condition where the heart suddenly can't pump enough blood to meet the body's needs.

References

  1. http://clinicaltrials.eu/trial/study-on-andexanet-alfa-for-patients-on-factor-xa-inhibitors-apixaban-rivaroxaban-edoxaban-needing-urgent-surgery-to-reduce-bleeding-risk/