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 (see also WARNINGS, Hemorrhage, and PRECAUTIONS, Drug Interactions).
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NEWS HIGHLIGHTSMedia Articles Related to Innohep (Tinzaparin)
Deep Vein Thrombosis (DVT) Source: MedicineNet Antiphospholipid Syndrome Specialty [2008.04.30] Title: Deep Vein Thrombosis (DVT) Category: Diseases and Conditions Created: 2/15/2000 10:55:00 PM Last Editorial Review: 4/30/2008
AHA: Rivaroxaban Cuts Risk of VTE in Joint Replacement (CME/CE) Source: MedPage Today Cardiovascular [2009.11.18] ORLANDO (MedPage Today) -- Rivaroxaban, an investigative oral factor Xa inhibitor, appears to reduce the risk of deep vein thrombosis by 50% among hip and knee replacement patients when compared with enoxaparin (Lovenox), researchers reported here.
Published Studies Related to Innohep (Tinzaparin)
The relationship between baseline blood pressure and computed tomography findings in acute stroke: data from the tinzaparin in acute ischaemic stroke trial (TAIST). [2009.01] BACKGROUND AND PURPOSE: High blood pressure (BP) is present in approximately 80% of patients with acute ischemic stroke and is independently associated with poor outcome. There are few data examining the relationship between admission BP and acute CT findings... CONCLUSIONS: Although high baseline BP is independently associated with a poor outcome after stroke, this was not shown to be through an association with increased hemorrhagic transformation, cerebral edema, or mass effect; trial design may be suboptimal to detect this. Higher SBP is associated with visible infarction on day 10 scans. The influence of changing BP in acute stroke on CT findings is still to be ascertained.
Sex differences in quality of life in stroke survivors: data from the Tinzaparin in Acute Ischaemic Stroke Trial (TAIST). [2007.11] BACKGROUND AND PURPOSE: Female sex is predictive of poor functional outcome in stroke, even after correction for prognostic factors. Poor quality of life (QoL) is observed in stroke survivors with lower scores seen in the most disabled patients. We used data from the Tinzaparin in Acute Ischaemic Stroke Trial (TAIST) to assess the relationship between sex and QoL after ischemic stroke... CONCLUSIONS: QoL, in particular physical function and mental health domains, is lower in female patients after stroke. This difference persists even after correction for known prognostic factors such as age and stroke severity.
Reduction of painful vaso-occlusive crisis of sickle cell anaemia by tinzaparin in a double-blind randomized trial. [2007.08] A randomized double-blind clinical trial was performed to test the safety and efficacy of a low-molecular-weight heparin, tinzaparin (Innohep), for the management of acute painful vasoocclusive crisis characteristic of sickle cell anemia (SCA). We studied 253 patients with acute painful crisis but with no other complications of SCA, randomized to treatment or control groups...
Tinzaparin and enoxaparin given at prophylactic dose for eight days in medical elderly patients with impaired renal function. A comparative pharmacokinetic study. [2007.04] Low-molecular-weight heparins (LMWHs) accumulate in patients with impaired renal function...
Stroke severity, early recovery and outcome are each related with clinical classification of stroke: data from the 'Tinzaparin in Acute Ischaemic Stroke Trial' (TAIST). [2007.03.15] INTRODUCTION: Baseline severity and clinical stroke syndrome (Oxford Community Stroke Project, OCSP) classification are predictors of outcome in stroke. We used data from the 'Tinzaparin in Acute Ischaemic Stroke Trial' (TAIST) to assess the relationship between stroke severity, early recovery, outcome and OCSP syndrome... CONCLUSIONS: Although functional outcome is related to baseline clinical syndrome (best with LACI, worst with TACI), patients who improve early have a more favourable functional outcome, irrespective of their OCSP syndrome. Hence, patients with a TACI syndrome may still achieve a reasonable outcome if early recovery occurs.
Clinical Trials Related to Innohep (Tinzaparin)
Tinzaparin in the Treatment of the Acute Pulmonary Embolism [Recruiting]
The purpose of this study is to evaluate the feasibility of the long-term treatment of
pulmonary embolism with tinzaparin compared to oral anticoagulants.
A Comparison of Dalteparin and Tinzaparin for Prevention of Blood Clots in Hemodialysis Patients on Oral Anticoagulants Having Surgery [Recruiting]
The purpose of this study is to better understand if either dalteparin or tinzaparin is a
better drug to use in dialysis patients on blood thinners who are at high risk of developing
blood clots and need surgery.
Use of Low Molecular Weight Heparin (Tinzaparin) to Treat Blood Clots in Patients With Kidney Failure [Recruiting]
Blood clots in the leg veins, known as deep vein thrombosis, are important because they may
travel to the lung (known as pulmonary embolism) and cause death. Blood clots are treated
with blood thinners, or anticoagulants. The preferred treatment is an anticoagulant known
as low molecular weight heparin (LMWH). LMWH is given by an injection under the skin, which
is convenient for patients because they can self-administer this medication at home, and no
blood testing is required. However, LMWH is cleared from the body through the kidneys, so
patients who have kidney failure are generally not treated with LMWH because they may be at
a higher risk of bleeding.
One type of LMWH, known as tinzaparin, may be less dependent on the kidneys for clearance
and may not increase in patients with kidney failure. The investigators would like to use
tinzaparin to treat patients who have deep vein thrombosis or pulmonary embolism, and who
also have kidney failure.
The purpose of this study is to determine whether the blood thinning effects of tinzaparin
build up, or accumulate, in patients with varying degrees of kidney failure compared to
patients without kidney failure. The blood thinning effects will be measured using a blood
test known as an anti-Xa level. Patients will be followed over the time they receive
tinzaparin and those patients who are found to have potentially high levels of tinzaparin
(based on the anti-Xa level) will have their tinzaparin dose adjusted. The investigators
believe that the levels of tinzaparin will not accumulate to potentially dangerous levels in
a significant number of patients with kidney failure.
Safety and Efficacy of Therapeutic Anticoagulation With Tinzaparin During Pregnancy Via Weight-Based Dosing [Recruiting]
The purpose of this study is to evaluate the safety and efficacy of therapeutic
anticoagulation with tinzaparin during pregnancy via weight-based dosing.
Effects of Tinzaparin on Cardio-Vascular Outcomes and on Blood Lipids in Diabetic Patients on Chronic Hemodialysis [Not yet recruiting]
Low molecular weight heparin (LMWH) provides a safe and effective alternative to UFH for
hemodialysis anticoagulation. While unfractionated (UF) heparin has been implicated in
hyper-lipidemia, the effect of LMWHs on the lipid profile in non-diabetic patients on
chronic hemodialysis remains controversial. The effect of LMWH in diabetic patients, a high
risk group for developing hyper-lipidemia and cardio-vascular disease, has not been studied.
The study intends to examine the long-term effects of the replacement of UFH by LMWH
(tinzaparin sodium) on cardio-vascular outcomes and on lipoprotein profiles in a large group
of diabetic patients stable on HD.
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