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Dalteparin Sodium

Dalteparin Sodium, also known by the brand name Fragmin, is a low molecular weight heparin (LMWH) that has been the subject of several clinical trials. These studies aim to evaluate its effectiveness and safety in preventing and treating various conditions, including blood clots, venous thromboembolism (VTE), and complications in patients with diabetes and traumatic brain injuries. This article summarizes key findings from recent clinical trials using Dalteparin Sodium.

Table of Contents

What is Dalteparin Sodium?

Dalteparin sodium, also known by the brand name Fragmin, is a type of medication called a low molecular weight heparin (LMWH)[1]. It is an anticoagulant, which means it helps prevent blood clots from forming[2]. Dalteparin sodium is derived from heparin, a naturally occurring substance in the body that helps prevent blood clotting.

What is Dalteparin Sodium Used For?

Dalteparin sodium is used to treat and prevent various conditions related to blood clots, including:

  • Venous thromboembolism (VTE): This includes deep vein thrombosis (DVT), which are blood clots in the deep veins of the legs, and pulmonary embolism (PE), which are blood clots in the lungs[1][3].
  • Prevention of VTE in cancer patients: Dalteparin can be used to prevent blood clots in patients with cancer who are at high risk[1].
  • Prevention of VTE after surgery or in bedridden patients: It can help prevent blood clots in patients who have had surgery or are confined to bed due to illness[4].
  • Treatment of acute coronary syndromes: This includes conditions like unstable angina and heart attacks[5].
  • Prevention of pregnancy complications: In some cases, dalteparin may be used to prevent blood clot-related complications during pregnancy in women with certain risk factors[6].
  • Treatment of superficial thrombophlebitis: This is inflammation of veins just below the skin’s surface[7].

How Does Dalteparin Sodium Work?

Dalteparin sodium works by enhancing the effect of a natural substance in the body called antithrombin III. This substance helps to inactivate certain clotting factors in the blood, particularly Factor Xa. By boosting the action of antithrombin III, dalteparin sodium helps to prevent the formation of new blood clots and stops existing clots from growing larger[1].

How is Dalteparin Sodium Administered?

Dalteparin sodium is typically administered as a subcutaneous injection, which means it is injected just under the skin. The dosage and frequency of administration can vary depending on the condition being treated and individual patient factors. Some common dosing regimens include:

  • For VTE prevention in cancer patients: 5000 IU (international units) once daily[1].
  • For treatment of acute VTE: 200 IU/kg of body weight once daily[3].
  • For prevention of VTE after surgery: 5000 IU once daily[4].

Your healthcare provider will determine the appropriate dose for your specific situation.

Effectiveness of Dalteparin Sodium

Clinical trials have shown dalteparin sodium to be effective in various scenarios:

  • In cancer patients, it has been shown to reduce the risk of VTE without significantly increasing the risk of bleeding[1].
  • For treating acute DVT, dalteparin has been found to be effective in resolving clots and preventing their recurrence[3].
  • In patients with diabetic foot ulcers, dalteparin may help improve healing rates, although more research is needed in this area[5].

Potential Side Effects

Like all medications, dalteparin sodium can cause side effects. The most common and important side effects to be aware of include:

  • Bleeding: This is the most significant risk. It can range from minor bleeding (like nosebleeds or bruising easily) to major bleeding events[1][5].
  • Pain or irritation at the injection site
  • Allergic reactions: These are rare but can occur
  • Thrombocytopenia: A decrease in blood platelets, which can increase the risk of bleeding[8].

It’s important to report any unusual symptoms or side effects to your healthcare provider promptly.

Use in Special Populations

Dalteparin sodium may be used in certain special populations, but requires careful consideration and monitoring:

  • Pregnant women: In some cases, dalteparin may be used to prevent pregnancy complications in women with certain risk factors. However, its use during pregnancy should be carefully evaluated by a healthcare provider[6].
  • Elderly patients: Older adults may be at higher risk of bleeding complications and may require dose adjustments.
  • Patients with kidney problems: The dosage may need to be adjusted in patients with impaired kidney function.
  • Patients with traumatic brain injury: The use of dalteparin in these patients is being studied to determine if it can safely prevent blood clots without increasing the risk of brain bleeding[9].

Always inform your healthcare provider about all your medical conditions and medications you’re taking before starting dalteparin sodium treatment.

Study Focus Key Findings Patient Population Dosage
Venous Thromboembolism Prevention Dalteparin showed potential in preventing VTE in various patient groups Trauma patients, postpartum women, medical patients 5,000 IU daily to 200 IU/kg daily
Pregnancy Complications Under investigation for preventing complications in thrombophilic pregnant women Pregnant women with thrombophilia 5,000 IU daily, increasing to twice daily later in pregnancy
Diabetic Foot Ulcers Showed potential in improving healing of neuroischaemic foot ulcers Diabetic patients with foot ulcers 5,000 IU daily
Traumatic Brain Injury Being studied for VTE prevention in severe TBI patients Patients with severe traumatic brain injury 5,000 IU daily for 7 days
Superficial Thrombophlebitis Compared to ibuprofen for treating superficial thrombophlebitis Patients with superficial thrombophlebitis 200 units/kg on day one, followed by 10,000 units daily for six days

FAQ

  • What is Dalteparin Sodium used for in clinical trials? Dalteparin Sodium is being studied for various uses, including prevention of blood clots after surgery or injury, treatment of deep vein thrombosis and pulmonary embolism, prevention of pregnancy complications in women with thrombophilia, and treatment of diabetic foot ulcers.
  • How is Dalteparin Sodium administered in these trials? In most trials, Dalteparin Sodium is administered through subcutaneous injections. The dosage and frequency vary depending on the condition being treated, ranging from once daily to twice daily injections.
  • Are there any side effects associated with Dalteparin Sodium use? The main side effect monitored in these trials is bleeding. Researchers carefully track both major and minor bleeding events. Other potential side effects include pain at the injection site and, rarely, a decrease in platelet count.
  • How long do patients typically receive Dalteparin Sodium in these trials? The duration of treatment varies widely depending on the condition and study design. Some trials administer Dalteparin Sodium for as short as 7 days, while others continue treatment for several months, especially in pregnancy-related studies.
  • What are some of the key outcomes measured in Dalteparin Sodium clinical trials? Key outcomes often include the incidence of blood clots or VTE, healing of ulcers in diabetic patients, pregnancy complications, bleeding events, and quality of life measures. Some studies also look at long-term outcomes such as mortality rates and functional neurological outcomes.

Ongoing Clinical Trials on Dalteparin Sodium

  • Study on Clopidogrel and Dalteparin Sodium for Preventing Blood Clots in Pancreatic Cancer Patients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway

  • Evaluation of enoxaparin, dalteparin, nadroparin, tinzaparin and human albumin in adults admitted to intensive care unit with acute critical illness

    Recruiting

    1 1 1 1
    Investigated drugs:
    Denmark Finland Iceland The Netherlands Sweden

  • Study on Dalteparin Sodium and Enoxaparin Sodium for Preventing Blood Clots in Patients Undergoing Liver Surgery

    Recruiting

    1 1 1 1
    Investigated drugs:
    Norway

  • Study on Venous Thromboembolism Prevention with Enoxaparin Sodium and Drug Combination for Patients Undergoing Total Hip or Knee Replacement

    Recruiting

    1 1 1 1
    Investigated drugs:
    The Netherlands

  • Study Comparing Rivaroxaban and Drug Combination for Preventing Blood Clots in Patients with Lower Limb Injuries Requiring Immobilization

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Best Antithrombotic Therapy for Patients with Acute Venous Thromboembolism Using Tinzaparin Sodium and Drug Combination

    Recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Study on Preventing Blood Clots in Patients with Advanced Germ Cell Tumors Using Cisplatin and a Drug Combination

    Recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Testing a Drug Combination for Personalized Sepsis Treatment in Children and Adults with Severe Blood Infection

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Abelacimab and Dalteparin for Preventing Blood Clots in Patients with Gastrointestinal or Genitourinary Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia France Germany Hungary Ireland +6

  • Study on Tinzaparin and Dalteparin for Patients with Venous Thromboembolism

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Venous Thromboembolism (VTE): A condition where blood clots form in the veins, typically in the legs (deep vein thrombosis) or lungs (pulmonary embolism).
  • Low Molecular Weight Heparin (LMWH): A type of anticoagulant medication derived from heparin, used to prevent and treat blood clots. Dalteparin Sodium is a type of LMWH.
  • Subcutaneous: A method of administering medication by injecting it under the skin.
  • Thrombophilia: A condition where the blood has an increased tendency to form clots.
  • Pulmonary Embolism (PE): A blockage in one of the pulmonary arteries in the lungs, often caused by blood clots that travel from the legs or other parts of the body.
  • Deep Vein Thrombosis (DVT): A blood clot that forms in a deep vein, usually in the leg.
  • Neuroischaemic Foot Ulcer: A type of foot ulcer in diabetic patients caused by poor blood circulation and nerve damage.
  • Placebo: A substance with no active therapeutic effect, used as a control in clinical trials to test the effectiveness of a drug.
  • Randomized Controlled Trial: A type of scientific experiment where participants are randomly assigned to different treatment groups to compare outcomes.
  • Anticoagulant: A medication that helps prevent blood clots from forming or growing larger.

References

  1. https://clinicaltrials.gov/study/NCT00952380
  2. https://clinicaltrials.gov/study/NCT01050153
  3. https://clinicaltrials.gov/study/NCT00480636
  4. https://clinicaltrials.gov/study/NCT00655122
  5. https://clinicaltrials.gov/study/NCT00662831
  6. https://clinicaltrials.gov/study/NCT00967382
  7. https://clinicaltrials.gov/study/NCT00264381
  8. https://clinicaltrials.gov/study/NCT01274637
  9. https://clinicaltrials.gov/study/NCT03559114