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Heparin (Heparin Sodium) - Summary

 
 



HEPARIN SUMMARY

INTRAVENOUS SOLUTIONS
WITH HEPARIN SODIUM INJECTION

Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration.

Heparin sodium is indicated for:

Atrial fibrillation with embolization;

Diagnosis and treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);

Prevention of clotting in arterial and heart surgery;

Prophylaxis and treatment of peripheral arterial embolism;

As an anticoagulant in extracorporeal arterial circulation and dialysis procedures.


See all Heparin indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Heparin

Consistency of Signals in Bivalirudin/Heparin Meta-Analysis
Source: theheart.org | Medscape Cardiology Headlines [2014.08.14]
UPDATED // Authors of a new meta-analysis of bivalirudin vs heparin trials of PCI patients say their findings provide a cool second look at a debate that reached a new boiling point in HEAT-PPCI.
Heartwire

Heparin in Stent Patients: New Love for an Old Friend (CME/CE)
Source: MedPage Today Cardiovascular [2014.08.14]
(MedPage Today) -- Results of a meta-analysis of data from some 34,000 PCI patients suggest that Angiomax (bivalirudin) may not be the best choice for anticoagulation in stent patients, but an old, cheap drug -- heparin -- could be.

Potential for future prevention of prion conversion and disease using heparin
Source: CJD / vCJD / Mad Cow Disease News From Medical News Today [2014.03.26]
Prions are infectious agents responsible for neurodegenerative diseases such as bovine spongiform encephalitis (commonly known as "mad cow disease") and Creutzfeldt-Jakob disease in humans.

more news >>

Published Studies Related to Heparin

Anti-inflammatory effect of low-molecular-weight heparin in pediatric cataract surgery: a randomized clinical trial. [2012]
DESIGN: Prospective masked randomized controlled trial... CONCLUSION: The results of our study suggest that there does not seem to be a

Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis. [2012]
setting... CONCLUSIONS: The combination of alkalinized lidocaine and heparin provides up to

Incidence of thrombotic and bleeding complications during cardiac catheterization in children: comparison of high-dose vs. low-dose heparin protocols. [2011.12]
Summary.Although Heparin Anticoagulation Randomized Trial in Cardiac Catheterization (HEARTCAT) was not designed as non-inferiority trial, low-dose UFH (50 units kg(-1) bolus) appears sufficient for thromboprophylaxis during CC.

Comparison of enoxaparin and unfractionated heparin in endovascular interventions for the treatment of peripheral arterial occlusive disease: a randomized controlled trial. [2011.11]
BACKGROUND: Although unfractionated heparin (UFH) is an effective antithrombotic agent in endovascular interventions for the treatment of peripheral occlusive arterial disease (PAOD), it produces a highly variable anticoagulant response. Intravenous (i.v.) enoxaparin might be an effective and safe alternative... CONCLUSION: Enoxaparin has a better performance than UFH in endovascular interventions for the treatment of PAOD. In patients with concomitant use of ASA, the risk of complications with UFH increases significantly compared with enoxaparin. (c) 2011 International Society on Thrombosis and Haemostasis.

Intravenous enoxaparin or unfractionated heparin in primary percutaneous coronary intervention for ST-elevation myocardial infarction: the international randomised open-label ATOLL trial. [2011.08.20]
BACKGROUND: Primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction has traditionally been supported by unfractionated heparin, which has never been directly compared with a new anticoagulant using consistent anticoagulation and similar antiplatelet strategies in both groups. We compared traditional heparin treatment with intravenous enoxaparin in primary PCI... INTERPRETATION: Intravenous enoxaparin compared with unfractionated heparin significantly reduced clinical ischaemic outcomes without differences in bleeding and procedural success. Therefore, enoxaparin provided an improvement in net clinical benefit in patients undergoing primary PCI. FUNDING: Direction de la Recherche Clinique, Assistance Publique-Hopitaux de Paris; Sanofi-Aventis. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

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Clinical Trials Related to Heparin

Sodic Heparin Effectiveness of the Treatment of Burns [Not yet recruiting]
Burns are injuries caused by agents thermal, chemical, electrical or radioactive who act in the tissue lining of the human body and may partially or totally destroy the skin and its annexes, to the deeper layers, as subcutaneous tissue, muscles, tendons and bones .

Studies show that topical heparin has, in addition to the already known anticoagulant activity, anti-inflammatory properties, analgesic, and neoangiogenic, stimulating blood flow and increasing the repair of the fabric as well as the restoration of collagen and reepiteliztion. Moreover, the use of heparin reduces the need for painful medical procedures, as debridations, surgeries and transplants The intention of this work is to verify the effectiveness and safety of sodium heparin in the treatment of burns of the skin.

Heparin Versus no Heparin on Duration of Peripherally Inserted Central Catheter (PICC) Patency in Neonates [Not yet recruiting]
Background: Heparin is an anticoagulant commonly used in the neonatal population as a means to prevent catheter related occlusion and malfunction by thrombosis (clot). Given the recent overdoses of infants using heparin, there is concern as to whether heparin should be used in peripherally inserted central venous catheters (PICC). Scientific evidence comparing the duration of use of heparin versus no heparin in PICCs is conflicting.

Purpose: The purpose of this study is to evaluate the effect of continuous IV fluids with heparin versus IV fluids without heparin on the duration of percutaneously inserted central venous catheters (PICC) in neonates.

Design: Prospective, double-blind, randomized controlled trial Hypothesis: The use of heparin in PICC fluids has no difference on duration of catheter patency.

Design and Methods: The study will be conducted at the Neonatal Intensive Care Unit at University Hospital, San Antonio, TX. Randomization to either the experimental group (no-heparin) or the standard medical group (with heparin) will occur once parental consent is obtained and prior to PICC insertion. PICC placement will be done by the PICC certified neonatal nurses. Correct placement of the PICC will be assured by radiography which is standard procedure.

Parents, NICU team members and staff, and investigators will be masked to the grouping. Pharmacy will be responsible for randomization. Both the heparin group and the no heparin group solutions will be dispensed in identical containers, compounded by the pharmacy.

The study medication, heparin, will be mixed by the pharmacy at a standard dose of 0. 5 units/mL for the intravenous infusions used in the heparin group. The experimental group will receive only the base solution, whether it is 5% dextrose, 0. 9% sodium chloride, or total parenteral nutrition infused into the PICC line. Pharmacy and the NICU staff will ensure compatibility of heparin with other infusions. Heparin bonded catheters, heparin flushes, and hep-lock solutions are not used by the NICU service.

The primary outcome, duration of catheter use, is defined as the time (in hours) between insertion and removal of the catheter due to occlusion. Occlusion will be defined as the inability to push 1 mL of 0. 9% sodium chloride, via a 5 mL syringe, through the catheter in situ or detection of clots along the catheter after removal.

Secondary outcomes include septicemia vs. catheter-related septicemia, phlebitis, death before discharge, and thrombosis. Septicemia is identified as clinical signs and symptoms associated with sepsis in the presence of a positive peripheral blood culture obtained irrespective of the catheter tip culture result. Catheter-related sepsis will be defined as positive blood culture obtained from the catheter fluid as well as a positive blood culture obtained from a peripheral venous specimen. Both cultures must demonstrate the same organism. Phlebitis is defined by visual detection, swelling, and change of skin color associated with an inflamed vein. Thrombosis is defined as a thrombus along catheter path diagnosed by visual inspection upon removal of the catheter. Elective versus non-elective removal will also be recorded.

Adverse events monitored include: heparin induced thrombocytopenia (HIT), defined as a platelet count dropping below 50 x 103/mL with a positive antibody titer, aPTT > 100 seconds (This will be measured upon clinical evidence of bleeding), hemorrhage from > 2 sites, intraventricular hemorrhage, extravasation, and dislodgement or breakage of catheter.

The sample size will be determined based on retrospective data collection to reach a statistical power of 80% with a type I error or 0. 05. The investigators expect the sample size to be approximately 102 patients in each arm of the study.

The study will terminate once the PICC is discontinued or if there is an indication to stop the study early for safety reasons. These could include increased adverse events in one group versus the other. A Safety Control Panel composed of 2 neonatologists from another site will review the data at the points when 1/3 and then 2/3 of total patient enrollment has been achieved.

Data Collection and Analysis: Data will be collected and tabulated on a Microsoft Excel spreadsheet using unique patient identifiers and stored at a secure location at UHS then analyzed using appropriate statistical tests.

Efficacy and Safety of Sodium Heparin in Patients (Cristália) [Not yet recruiting]

A Non-inferiority Study Comparing Two Heparin Sodium Preparations in Hip Fracture Surgery [Not yet recruiting]
The primary objective and endpoints of the study is compare the efficacy of two products containing heparin sodium, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.

Comparison of Heparin Types; Efficacy and Safety [Not yet recruiting]

more trials >>

Reports of Suspected Heparin Side Effects

Heparin-Induced Thrombocytopenia (79)Thrombocytopenia (34)Haemorrhage (29)Dyspnoea (24)Cerebral Haemorrhage (23)Pyrexia (21)Pulmonary Embolism (20)Gastrointestinal Haemorrhage (15)Thrombosis in Device (15)Nausea (15)more >>


Page last updated: 2014-08-14

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