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).
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NEWS HIGHLIGHTS
Published Studies Related to Fragmin (Dalteparin)
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.
Long-term effect of dalteparin in the prevention of neovascularization of iris in recent-onset central retinal vein occlusion. [2008.09]
BACKGROUND: To compare the long-term effect of dalteparin in the prevention of neovascularization of iris in recent-onset central retinal vein occlusion with that of aspirin... CONCLUSION: Patients treated with dalteparin within 30 days of the onset of central retinal vein occlusion were less likely to develop neovascularization of iris. There was also a significant difference in the visual acuity between two groups.
Xa inhibition and coagulation activity--the influence of prolonged dalteparin treatment and gender in patients with acute coronary syndrome and healthy individuals. [2008.03]
BACKGROUND: We evaluated coagulation activity in relation to gender in patients with acute coronary syndromes and in healthy individuals of similar age, and related coagulation activity to levels of Xa inhibition during dalteparin treatment... CONCLUSIONS: Despite weight-adjusted dosing, female patients reached higher anti-Xa levels, suggesting increased sensitivity to dalteparin treatment. Healthy women and female patients also had higher coagulation activity, which might increase the risk of thrombus formation. The large proportion of patients with subtherapeutic anti-Xa during prolonged dalteparin treatment may reflect poor compliance and could thus contribute to the gradual loss of clinical efficacy.
Long-term dalteparin in pregnancy not associated with a decrease in bone mineral density: substudy of a randomized controlled trial. [2007.08]
Background: The risk of decreased bone mineral density (BMD) with prophylactic dose long-term low-molecular-weight heparin (LMWH) is unknown. Objectives: We sought to determine whether long-term prophylactic dalteparin in pregnancy leads to loss of BMD... Conclusions: Our results suggest that the use of long-term prophylactic dalteparin in pregnancy is not associated with a significant decrease in BMD.
Prolonged thromboprophylaxis with Dalteparin during immobilization after ankle fracture surgery: a randomized placebo-controlled, double-blind study. [2007.08]
BACKGROUND: Skeletal trauma and immobilization are well-known risk factors for deep vein thrombosis (DVT) and pulmonary embolism (PE). While prophylaxis against thromboembolic complications has become routine after major orthopedic surgery, whether or not prophylaxis after minor surgery and lower limb immobilization is necessary is still under debate...
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.
Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT) [Completed]
The investigators' primary research objective is:
- To determine the safety of dalteparin prophylaxis, 5,000 IU once-daily, in Intensive
Care Unit (ICU) patients based on:
- the proportion of patients with trough anti-Xa > 0. 40 IU/mL during dalteparin
prophylaxis after 3 + 1 days, 10 + 1 days, and 17 + 1 days of dalteparin
prophylaxis;
- the risk of major bleeding during the treatment period.
The investigators' secondary research objectives are:
- To determine the pharmacokinetic properties of dalteparin prophylaxis in ICU patients
with severe renal insufficiency;
- To identify clinical and laboratory factors that predict an excessive anticoagulant
effect (anti-Xa > 0. 10 IU/mL);
- To estimate the relationship between trough anti-Xa levels and bleeding.
The DIRECT Pilot Study:
Before embarking on a large trial of low molecular weight heparin (LMWH) versus standard
unfractionated heparin (UFH), the DIRECT Study is needed to observe whether bioaccumulation
of LMWH occurs in ICU patients with moderate to severe renal insufficiency, and to address
potential problems with protocol implementation.
Outpatient Treatment Of Deep Venous Thrombosis (DVT) Using Subcutaneous Dalteparin (Fragmin) In Low Risk Cancer Patients [Terminated]
Study Plan: Adult cancer patients who have a low risk profile and present with DVT will
receive dalteparin 200 IU/kg subcutaneously daily (based on actual body weight with a maximum
dose of 18,000 IU). Eligible patients who have signed the informed consent will be
instructed on injection technique, will give themselves their first subcutaneous injection
under supervision of the physician or the nurse and will be observed for a minimum of 1-2
hours prior to discharge. Patients may be admitted to an observation unit for up to 24 hours
prior to discharge if medically necessary. Those patients without complications during the
observation period will be given discharge instructions and an outpatient schedule to see one
of the physician investigators daily for their subcutaneous injection of dalteparin, routine
lab work and initiation of oral anticoagulation therapy.
Patients that are proficient in administering their own injection with dalteparin will be
evaluated every other day by the physician investigator. On days of home injection, the
study nurse will call the patient to check on the patient’s status and to remind the patient
of his/her daily injection. Patients will undergo a physical examination every other day by
the physician investigator directed towards the clinically affected areas until a therapeutic
response (INR 2-3) on oral warfarin has been achieved or the patient’s clinical condition
warrants modification of therapy with or without hospitalization. Patients will remain on
study for a minimum of 5 days with at least 1 day of therapeutic oral anticoagulation.
The quality of life of the patients enrolled will be assessed by using the Modified Medical
Outcome Study Short Form-20. An adapted version of the Rotterdam Symptom Checklist will be
used to specifically assess patients with thrombosis. Patients will complete these two
instruments at study entry, day 3, day 5 and at the end of study if different from day 5.
Fragmin in Ovarian Cancer: Utility on Survival (FOCUS) [Recruiting]
Epithelial ovarian carcinoma (EOC) is the 5th leading cause of death among women. Long-term
survival is poor for the majority of women with EOC because many present with advanced
disease. Chemotherapy and cytoreductive surgery produces a 50% - 60% response rate but
relapse is not uncommon. Adding more systemic agents has failed to show a clear benefit in
survival and is associated with unacceptable toxicity. This phase II, dose-finding, open
label trial will enrol women with newly diagnosed EOC and randomize them to receive one of 3
doses of a LMWH dalteparin in conjunction with standard adjuvant taxane- and platinum-based
chemotherapy. The primary outcome is disease response, measured according to Gynaecologic
Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 response criteria. Secondary outcomes
include symptomatic venous thromboembolism, bleeding, and compliance. The dose of dalteparin
associated with the best response will be tested further in a phase III randomized clinical
trial in the same patient population.
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients [Recruiting]
To see the effect of Fragmin on the healing of diabetic foot ulcers by determining the
number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.
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