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Fragmin (Dalteparin Sodium) - Summary

 
 



SPINAL/EPIDURAL HEMATOMAS

When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.

The risk of these events is increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.

Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

The physician should consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (also see WARNINGS, Hemorrhage and PRECAUTIONS, Drug Interactions).

 

FRAGMIN SUMMARY

FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin.

FRAGMIN Injection is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy (as described in CLINICAL TRIALS, Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction).

FRAGMIN is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):

  • In patients undergoing hip replacement surgery;
  • In patients undergoing abdominal surgery who are at risk for thromboembolic complications;
  • In medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.


See all Fragmin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Fragmin (Dalteparin)

PRODIGE: a randomized placebo-controlled trial of dalteparin low-molecular-weight heparin thromboprophylaxis in patients with newly diagnosed malignant glioma. [2010.09]
BACKGROUND AND OBJECTIVES: Venous thromboembolism (VTE) occurs in 20-30% of patients with malignant glioma per year of survival. We tested the efficacy of long-term dalteparin low-molecular-weight heparin (LMWH) for prevention of VTE in these patients... CONCLUSIONS: Trends suggesting reduced VTE and increased intracranial bleeding were seen in the LMWH thromboprophylaxis group. The role of long-term anticoagulant thromboprophylaxis in patients with brain tumors remains uncertain. (c) 2010 International Society on Thrombosis and Haemostasis.

Weight-adjusted dalteparin for prevention of vascular thromboembolism in advanced pancreatic cancer patients decreases serum tissue factor and serum-mediated induction of cancer cell invasion. [2010.07]
The aim of the present study was to assess the role of tissue factor and serum-induced cell invasion in patients with advanced pancreatic cancer (APC). A cohort of 39 patients with APC, without thrombosis, receiving chemotherapy, were entered in a randomized controlled trial (ISRCTN = 76464767) of thromboprevention with weight-adjusted dalteparin (WAD)...

PRODIGE: a randomized placebo-controlled trial of dalteparin low molecular weight heparin (LMWH) thromboprophylaxis in patients with newly diagnosed malignant glioma. [2010.06.28]
Summary Background and Objectives: Venous thromboembolism (VTE) occurs in 20-30% of patients with malignant glioma per year of survival. We tested the efficacy of long-term dalteparin low molecular weight heparin (LMWH) for prevention of VTE in these patients.The role of long-term anticoagulant thromboprophylaxis in patients with brain tumors remains uncertain.

Early and short-term acenocumarine or dalteparin for the prevention of central vein catheter-related thrombosis in cancer patients: a randomized controlled study based on serial venographies. [2009.12]
BACKGROUND: We evaluated efficacy and safety of early and short-term prophylaxis with acenocumarine or dalteparin in the prevention of non-occlusive or occlusive central vein catheter-related thrombosis (CVCrT)... CONCLUSIONS: In this study of early and short-term prophylaxis, acenocumarine was more effective than dalteparin on non-occlusive and asymptomatic CVCrT events. The first days following CVC insertion represent the highest risk for CVCrT.

Dalteparin for the prevention of recurrence of placental-mediated complications of pregnancy in women without thrombophilia: a pilot randomized controlled trial. [2009.01]
BACKGROUND: The role of anticoagulants for the prevention of placental-mediated pregnancy complications is uncertain. OBJECTIVES: Our aim was to investigate the effectiveness of dalteparin, a low-molecular-weight heparin, in preventing the recurrence of these complications in women without thrombophilia... CONCLUSION: In this pilot study, dalteparin is effective in decreasing the recurrence of placental-mediated complications in women without thrombophilia. Our results require confirmation in further randomized trials.

more studies >>

Clinical Trials Related to Fragmin (Dalteparin)

Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients [Enrolling by invitation]
To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.

The Clinical Utility of Thrombelastography in Guiding Prophylaxis of Venous Thromboembolism Following Trauma [Recruiting]
This study plans to learn more about how to prevent blood clots in the veins of your extremities. You are at risk of forming these clots after a major injury and when you have had surgery and are hospitalized on bed rest.

Usually, patients in the SICU at Denver Health who are at risk for blood clots receive preventative treatment with a FDA-approved medicine called Fragmin. Fragmin is intended to prevent blood clots from forming but, with the way it is generally used, some patients may still develop blood clots. All patients treated with Fragmin to prevent blood clots at Denver Health, currently receive the same Fragmin dose. This treatment is called the "standard of care".

So far, in the US, there has not been a commonly available test that can tell us:

- if the standard dose of Fragmin is enough to prevent blood clots for everyone, or

- if different patients need different doses, or

- if other blood clot preventing medicines, that work in a different way, should be used

in addition to Fragmin.

The ability of your blood to clot and the strength of the clot formed can be described by a FDA-approved blood test called thrombelastography, referred to as TEG. TEG may provide us with answers to each of the questions above. Our preliminary data indicate that it is helpful in assessing both clotting and bleeding tendencies and may prove useful in guiding treatment for the prevention of blood clots.

The aim of this study is to determine if a treatment plan using Fragmin, and, if indicated, one or two additional FDA-approved medicines called anti-platelet drugs, guided by the results of TEG testing, may be better at preventing blood clots than our current standard of care.

Dalteparin and Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic or Unresectable Kidney Cancer [Recruiting]
This phase I trial is studying the side effects and best dose of dalteparin when given together with sunitinib malate in treating patients with metastatic or unresectable kidney cancer. Anticoagulants, such as dalteparin, help prevent blood clots and have been shown to increase survival in patients with cancer. Anticoagulants may also prevent the formation of new blood vessels. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by inhibiting new blood vessels and blocking blood flow to the tumor. Giving dalteparin together with sunitinib malate may starve tumors and kill more tumor cells

Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients [Recruiting]
The goal of this clinical research study is to learn if dalteparin can lower the risk of venous thromboembolism (VTE) occurring in the legs and lungs. This will be tested in patients with pancreatic cancer who are going to receive chemotherapy. Some patients will receive dalteparin and some will receive no study drug.

The safety of dalteparin will also be studied.

Dalteparin, Lenalidomide, and Low-Dose Dexamethasone in Treating Patients With Previously Untreated Multiple Myeloma [Recruiting]
This randomized pilot phase II trial studies how well giving dalteparin, lenalidomide, and low-dose dexamethasone together works in treating patients with previously untreated multiple myeloma. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with lenalidomide and dexamethasone for multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dalteparin, lenalidomide, and dexamethasone together may be an effective treatment for multiple myeloma

more trials >>

Reports of Suspected Fragmin (Dalteparin) Side Effects

Pulmonary Embolism (15)Pancytopenia (10)Liver Injury (9)Cerebral Infarction (9)Vascular Occlusion (8)Diarrhoea (8)Colitis (8)Drug Interaction (7)Cerebral Haemorrhage (7)Neoplasm Malignant (6)more >>


Page last updated: 2011-12-09

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