NEWS HIGHLIGHTS
Published Studies Related to Heparin
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.
A multicenter, randomized trial comparing heparin/warfarin and acetylsalicylic acid as primary thromboprophylaxis for 2 years after the Fontan procedure in children. [2011.08.02]
OBJECTIVES: The purpose of this study was to compare the safety and efficacy of acetylsalicylic acid (ASA) and warfarin for thromboprophylaxis after the Fontan procedure. BACKGROUND: Fontan surgery is the definitive palliation for children with single-ventricle physiology. Thrombosis is an important complication; the optimal thromboprophylaxis strategy has not been determined... CONCLUSIONS: There was no significant difference between ASA and heparin/warfarin as primary thromboprophylaxis in the first 2 years after Fontan surgery. The thrombosis rate was suboptimal for both regimens, suggesting alternative approaches should be considered. (International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures; NCT00182104). Copyright (c) 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Unfractionated heparin for second trimester placental insufficiency: a pilot randomized trial. [2011.08]
OBJECTIVE: To conduct a pilot randomized controlled trial of unfractionated heparin (UFH) in women considered at high risk of placental insufficiency in the second trimester... CONCLUSION: Our study design identified women at high risk of adverse maternal-infant outcomes attributable to placental insufficiency. Women with evidence of placental insufficiency were willing to undergo randomization and self-administration of UFH without increased maternal anxiety. (c) 2011 International Society on Thrombosis and Haemostasis.
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 Comparison of Dilute Versus Concentrated Heparin for CRRT Anticoagulation [Recruiting]
Heparin is commonly used for anticoagulation of the extracorporeal circuit during continuous
renal replacement therapy (CRRT) but the optimal mode of delivery has not yet been
validated. Our study will compare dilute heparin to a standard concentration of heparin.
The investigators hypothesize that heparin delivered in a dilute solution will augment
coating of the filter fibers with anticoagulants, decreasing clotting events and increasing
filter life. By improving delivery of heparin to the filter and circuit, where clotting
events can disrupt dialysis, less heparin would be required for the extra-corporeal circuit
and thus less heparin would be delivered back to the patient with blood return from the
machine. By exposing the patient to less heparin it is hypothesized that fewer bleeding
events would occur, making the dialysis treatment safer. If more of the filter's fibers
remain patent and the filter is functional for a longer period of time, the CRRT would also
be more effective.
Safety and Efficacy of Lean Body Weight-based IV Heparin Dosing in Obese/Morbidly Obese Patients [Recruiting]
Standard weight-based IV heparin for normal weight patients is based on actual body weight
(ABW). However, no well-defined guidelines have been established for patients considered to
be obese or morbidly obese. In current practice, the calculated ABW based heparin initial
bolus dose and infusion rates are quite high, and therefore often not used for
obese/morbidly obese patients for fear of bleeding.
Heparin is distributed in the body approximately the same as blood and does not get
distributed to adipose tissue. There are some studies suggesting that lean body weight
(LBW) might be a better basis for dosing heparin. LBW is a calculated weight that excludes
the weight of fat.
The investigators hypothesize that intravenous heparin dosing based on the Lean body weight
of obese/morbidly obese patients would be safe and effective in achieving a therapeutic
level of heparin in 24 hours compared to the usual practice in this patient population.
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