NEWS HIGHLIGHTSMedia Articles Related to Heparin
U.S. Health Officials Announce New Heparin Formula
Source: MedicineNet Over-The-Counter Products Specialty [2009.10.02]
Title: U.S. Health Officials Announce New Heparin Formula
Category: Health News
Created: 10/1/2009 4:10:00 PM
Last Editorial Review: 10/2/2009
Published Studies Related to Heparin
Rationale and design of the HEALTHY-CATH trial: a randomised controlled trial of Heparin versus EthAnol Lock THerapY for the prevention of Catheter Associated infecTion in Haemodialysis patients. [2009.08.20]
BACKGROUND: Catheter-related bacteraemias (CRBs) contribute significantly to morbidity, mortality and health care costs in dialysis populations... DISCUSSION: This investigator-initiated study has been designed to provide evidence to help nephrologists reduce the incidence of CRBs in haemodialysis patients with tunnelled intravenous catheters.
A comparison of anticoagulation with bivalirudin and provisional GPIIb/IIIa inhibition with unfractionated heparin and mandatory GPIIb/IIIa inhibition during percutaneous coronary intervention in relation to platelet activation and the inhibition of coagulation. [2009.08]
CONCLUSIONS: Bivalirudin has some early advantages on platelet activation when compared to UFH. However, there are significant limitations in its mechanism of action, particularly a lack of release of tissue factor pathway inhibitor.
Adding intravenous unfractionated heparin to standard enoxaparin causes excessive anticoagulation not detected by activated clotting time: results of the STACK-on to ENOXaparin (STACKENOX) study. [2009.08]
BACKGROUND: The STACKENOX study assessed the cumulative anticoagulation effect of administering stack-on intravenous unfractionated heparin (UFH) to subjects already receiving enoxaparin... CONCLUSIONS: The administration of stack-on UFH to subjects already receiving recommended enoxaparin dosing may result in over-anticoagulation, and should be avoided. Activated clotting time assessment did not detect the over-anticoagulation resulting from co-administration of enoxaparin and UFH.
Luteal phase empirical low molecular weight heparin administration in patients with failed ICSI embryo transfer cycles: a randomized open-labeled pilot trial. [2009.07]
BACKGROUND: The pathology underlying recurrent implantation failures (RIF) is not clear and treatment options proposed are generally not evidence based. Although the effect of heparin on trophoblast biology has not been studied extensively, given the available data suggesting a possible beneficial effect of heparin on embryo implantation, we decided to undertake this pilot study... CONCLUSION: Despite lack of statistical significance, observed relative increase by 30% in live birth rates with LMWH may be regarded as a clinically significant trend necessitating further research on the use of empirical LMWH in women with RIF and possibly in all women undergoing assisted reproduction treatment. Failure to demonstrate statistical significance of the observed treatment difference may be due to limited sample size of this pilot study.
Sodium citrate versus heparin catheter locks for cuffed central venous catheters: a single-center randomized controlled trial. [2009.06]
BACKGROUND: Sodium citrate has antibacterial and anticoagulant properties that are confined to the catheter when used as a catheter lock. Studies of its use as a catheter lock have suggested its efficacy in preventing infection and bleeding complications compared with sodium heparin... CONCLUSION: Widespread and long-term use of 46.7% citrate catheter locks with Tesio-Cath access is not justified by this study.
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.
Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots [Not yet recruiting]
Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing
recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the
legs and/or blood clots in the lungs.
Efficacy of Sodium Heparin in Prophylaxis of Venous Thromboembolism in Surgical Patients [Not yet recruiting]
The Venous thromboembolism (VTE) disease is very frequent, mainly as complications of
medical diseases and surgical procedures. It has high prevalence and can lead to severe
complications such as pulmonary embolism and postthrombotic syndrome. Although its incidence
has been decreasing in recent years, the EP and DVT is still a major public health problem,
especially in advanced age.
The tracking of this disease through imaging tests in asymptomatic patients does not seem to
be a cost-effective, further treatment of complications is expensive and subject to no
satisfactory answers are not completely effective in regard to late complications.
Therefore, according CAIAFA & BASTOS (2002), effective prophylaxis is the best strategy.
The type of prevention to be used should be based on the risk of developing VTE, ie low,
medium or high. Framework for a category of risk for the indication of prophylaxis, each
patient should be evaluated individually and carefully to the risk of developing VTE. Maffei
et al. (2005) describe the "Standards for Clinical Guideline for the prevention, diagnosis
and treatment of deep vein thrombosis." According to the guide, the concentration of heparin
in 5. 000UI is indicated for cases of moderate-risk surgeries. Are classified as "moderate
risk" to more surgery (general, gynecological and urological) in patients 40 to 60 years
without additional risk factors, and the magnitude of any surgery in patients under 40 years
of age who use estrogen ( Annex 01). The dosing schedule chosen in this study also follows
the recommendation of the guide and is universally used .
According to Maffei et al. (2005), the diagnosis of VTE must be initiated by the history and
physical examination, and then must be performed ultrasound Doppler of lower limbs. Thus,
the ultra-sonography/doppler examination will be done at the beginning and end of treatment
and physical examination will be done periodically throughout the period of monitoring.
Following the guidelines proposed by the literature consulted, was established to test this
methodology, which aims to demonstrate the non inferiority clinical heparin sodium 5. 000UI /
0. 25 mL sodium heparin on 5. 000UI / 1. 0 mL, both produced by Blausiegel Industry and Trade
Ltda. in reducing the incidence of VTE. The two formulations are produced from the same
material, but have different drug concentrations. Thus, there is a need to scientifically
prove that the therapeutic activity and safety of the product test is non-inferior to the
comparator drug (Hepamax-S ® - 5. 000UI / 1. 0 mL), allowing the sponsoring company to obtain
the registration of the product in the concentration of 5000UI /0. 25 mL in ANVISA at the
proposed therapeutic indication in the study.
Efficacy and Safety of Sodium Heparin [Not yet recruiting]
|
