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European Heart Journal. Cardiovascular... Oct 2019
Topics: Anticoagulants; Blood Coagulation; Clinical Trials as Topic; Dalteparin; Factor Xa Inhibitors; Humans; Neoplasms; Pyridines; Recurrence; Risk Factors; Secondary Prevention; Thiazoles; Treatment Outcome; Venous Thromboembolism
PubMed: 31378809
DOI: 10.1093/ehjcvp/pvz027 -
International Journal of Obstetric... Dec 2016Dalteparin is often used for prophylaxis or treatment of venous thromboembolism during pregnancy, yet there is no laboratory test to accurately reflect its clinical...
BACKGROUND
Dalteparin is often used for prophylaxis or treatment of venous thromboembolism during pregnancy, yet there is no laboratory test to accurately reflect its clinical activity. Thromboelastography is a point-of-care monitor of whole blood coagulation. The aim of this study was to determine if serial doses of dalteparin added in vitro to whole blood samples from term, pregnant women are detectable as changes in thromboelastography parameters.
METHODS
Thirty healthy parturients presenting for elective caesarean section were recruited. Dalteparin was added to whole blood samples to yield final concentrations of 0 (control), 0.05, 0.25, 0.5, 0.75 and 1.0U/mL anti-Xa activity. Thromboelastography tracings were obtained for all six samples using the standard kaolin protocol.
RESULTS
Significant differences were noted in median thromboelastography r time, k time, alpha angle and maximal amplitude between non-anticoagulated (⩽0.05U/mL) and samples ⩾0.5U/mL (P<0.05). The r time and k time presented with the highest sensitivities of 97.5 and 84.0, respectively.
CONCLUSION
This pilot study provides proof-of-concept that thromboelastography can discriminate differences in blood anticoagulated with varying doses of dalteparin in a dose-dependent manner. This suggests that thromboelastography may be a feasible monitor of anticoagulation in the presence of dalteparin in maternal whole blood and may potentially translate to a point-of-care test that can be used to determine real-time coagulation status in patients.
Topics: Adolescent; Adult; Anticoagulants; Dalteparin; Female; Humans; In Vitro Techniques; Middle Aged; Pilot Projects; Pregnancy; Thrombelastography; Young Adult
PubMed: 27717636
DOI: 10.1016/j.ijoa.2016.08.002 -
Reproductive Biomedicine Online Jun 2011This study evaluated whether heparin administration could affect IVF outcome. A total of 172 women, aged <40years, without laboratory findings of thrombophilia and... (Randomized Controlled Trial)
Randomized Controlled Trial
This study evaluated whether heparin administration could affect IVF outcome. A total of 172 women, aged <40years, without laboratory findings of thrombophilia and undergoing their first IVF cycle, were randomly allocated to treatment (n=86) and control (n=86) groups. Patients allocated to the treatment group received low-molecular-weight heparin dalteparin sodium 2500IU s.c. daily, in addition to routine luteal phase support, from oocyte retrieval up to the day of the pregnancy test or up to the ninth week of pregnancy in the cases of positive human chorionic gonadotrophin. From the day after the oocyte retrieval, all patients began standard supplementation with vaginal progesterone 200mg twice a day. At the sixth week of pregnancy, patients underwent an ultrasound scan to assess the number/viability of gestational sacs. Implantation rates were 15% and 12% in the dalteparin and control groups, respectively. The clinical pregnancy rates/embryo transfers were 26% (19/73) and 20% (16/80), in the dalteparin and control groups, respectively, with live birth rates/embryo transfer of 21% (15/73) and 16% (13/80). Despite the lack of statistical significance, the increase in pregnancies observed in the treatment group may be considered as an important clinical point in the optimization of IVF clinical outcome.
Topics: Adult; Dalteparin; Embryo Implantation; Embryo Transfer; Female; Fertilization in Vitro; Humans; Ovulation Induction; Pilot Projects; Pregnancy; Pregnancy Rate; Treatment Outcome
PubMed: 21498125
DOI: 10.1016/j.rbmo.2011.03.016 -
Clinical Therapeutics Apr 2003If a low-molecular-weight heparin (LMWH) injectable formulation maintains its stability for up to 30 days, substantial cost reductions in hospital stay could be achieved... (Comparative Study)
Comparative Study
BACKGROUND
If a low-molecular-weight heparin (LMWH) injectable formulation maintains its stability for up to 30 days, substantial cost reductions in hospital stay could be achieved with its use on an outpatient basis in patients who might otherwise be treated with IV heparin as inpatients.
OBJECTIVE
This study was designed to assess the stability for up to 30 days of injectable solutions of the LMWH dalteparin sodium when repackaged in plastic syringes.
METHODS
In the first part of the study, 1-mL and 3-mL plastic syringes were filled with the contents of a 10,000-IU/mL dalteparin ampule or a 25,000-IU/mL dalteparin multidose vial. In a separate part of the study, 1-mL and 3-mL syringes were filled with doses of 7500 IU and 10,000 IU, respectively, from a 10,000-IU/mL multidose vial. After the syringes were brought to room temperature or 4 degrees C, the stability of dalteparin was assessed over 30 days by measuring anti-factor Xa levels.
RESULTS
No significant loss of dalteparin activity was found for up to 30 days in the syringes after storage at room temperature or 4 degrees C. The solutions retained anti-factor Xa activity at room temperature and under refrigeration.
CONCLUSION
Dalteparin is stable for up to 30 days when stored at room temperature or 4 degrees C. The findings suggest that preparation of a postdischarge supply of dalteparin is feasible, contributing to more convenient and effective management of outpatients at risk for thrombotic complications.
Topics: Anticoagulants; Dalteparin; Drug Stability; Glass; Syringes; Temperature; Time Factors
PubMed: 12809968
DOI: 10.1016/s0149-2918(03)80078-4 -
Clinical Cardiology Jan 2000The mainstay of treatment for unstable coronary artery disease (UCAD) currently consists of antithrombotic therapy with aspirin plus unfractionated heparin (UFH),... (Clinical Trial)
Clinical Trial Review
The mainstay of treatment for unstable coronary artery disease (UCAD) currently consists of antithrombotic therapy with aspirin plus unfractionated heparin (UFH), together with anti-ischemic treatment with beta blockers and nitrates. Recently, there has been a trend toward replacement of UFH with low-molecular-weight heparins (LMWHs), since these products offer significant advantages over the parent compound. Several lines of evidence suggest that prolongation of treatment with LMWHs beyond the acute phase may be appropriate in patients with UCAD. The Fragmin and Fast Revascularization during InStability in Coronary artery disease (FRISC II) study was designed to evaluate this hypothesis using the LMWH dalteparin sodium (Fragmin). A factorial design was used to randomize patients enrolled in the FRISC II study to an invasive or noninvasive management strategy, and to treatment with dalteparin sodium or placebo. Treatment with dalteparin sodium significantly reduced incidences of death and/or myocardial infarction (MI) during the first months of treatment (the reduction in the relative risk of double endpoint events was statistically significant at 47.0% at 1 month, and remained so at 2 months, but was no longer statistically significant at the 3-month assessment). However, risk, as defined by the triple endpoint of death, MI, and revascularization, was significantly lower (13.0% relative risk reduction) at 3-month follow-up in the treatment group randomized to dalteparin sodium than among patients receiving placebo. In patients in whom revascularization procedures were carried out, the risk of new, postprocedural events was low in both the placebo and dalteparin sodium arms. Thus, dalteparin sodium appears to protect patients from cardiac events until they undergo invasive procedures, and it can therefore be used as a bridge to revascularization.
Topics: Angina, Unstable; Anticoagulants; Aspirin; Coronary Artery Disease; Dalteparin; Drug Therapy, Combination; Heparin, Low-Molecular-Weight; Humans; Prospective Studies; Randomized Controlled Trials as Topic; Stroke; Treatment Outcome
PubMed: 10680039
DOI: 10.1002/clc.4960231305 -
The New England Journal of Medicine Jul 2011
Topics: Anticoagulants; Critical Illness; Dalteparin; Heparin; Humans; Thrombocytopenia; Venous Thrombosis
PubMed: 21751919
DOI: 10.1056/NEJMc1105423 -
Delaware Medical Journal Feb 2000Dalteparin sodium injection in patients with an immunologic component to RPL resulted in an increase in compliance without any adverse early pregnancy outcomes.
Dalteparin sodium injection in patients with an immunologic component to RPL resulted in an increase in compliance without any adverse early pregnancy outcomes.
Topics: Abortion, Habitual; Adult; Anticoagulants; Dalteparin; Female; Humans; Injections, Subcutaneous; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Pregnancy Trimester, First; Retrospective Studies
PubMed: 10718009
DOI: No ID Found -
Clinical and Applied... Jun 2012Dalteparin and enoxaparin are recommended as thromboprophylaxis for at least 10 days in patients undergoing abdominal surgery (AS) or hospitalized patients with acute... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Dalteparin and enoxaparin are recommended as thromboprophylaxis for at least 10 days in patients undergoing abdominal surgery (AS) or hospitalized patients with acute medical illnesses. Even though both agents have proven clinical effectiveness through randomized trials, there have been no head-to-head studies. In this evaluation, indirect statistical techniques were used to compare safety and efficacy between dalteparin and enoxaparin in these 2 high-risk patient populations.
METHODS
A literature search was conducted from January 1980 to November 2010 for randomized trials evaluating dalteparin or enoxaparin prophylaxis following AS or in hospitalized patients. Binary outcomes for safety and efficacy were statistically pooled using fixed or random effects models in cases of significant heterogeneity. In trials where a common control was used (eg, unfractionated heparin [UH]), indirect statistical comparisons between dalteparin and enoxaparin were performed using meta-regression analysis with active drug as the primary independent variable.
RESULTS
The meta-analysis in AS patients showed that enoxaparin or dalteparin had comparable efficacy to UH in terms of venous thromboembolic events (VTEs; relative risk reduction [RR] = 0.87, P = .46). The indirect statistical comparison was unable to find significant differences between enoxaparin and dalteparin in terms of risk for VTE (P = .84), major bleeding (P = .38), heparin-induced thrombocytopenia ([HIT]; P = .084), or death (P = .97). In acutely ill medical patients, treatment with enoxaparin or dalteparin had a 52% VTE risk reduction compared to placebo (RR = 0.48, P < .001). The indirect comparison was also unable to find significant differences between enoxaparin and dalteparin in terms of VTEs (P = .15), major bleeds (P = .39), HIT (P = .48), and death (P = .41).
CONCLUSIONS
The findings suggest comparable safety and efficacy between dalteparin and enoxaparin in AS and in acutely ill medical patients.
Topics: Anticoagulants; Dalteparin; Enoxaparin; Female; Humans; Male; Randomized Controlled Trials as Topic; Risk Factors; Venous Thromboembolism
PubMed: 22387576
DOI: 10.1177/1076029611426869 -
Canadian Journal of Surgery. Journal... Feb 2010
Topics: Anticoagulants; Arthroplasty, Replacement, Knee; Blood Loss, Surgical; Dalteparin; Humans; Postoperative Complications; Thromboembolism
PubMed: 20100404
DOI: No ID Found -
Pediatric Blood & Cancer Dec 2020On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium for the treatment of symptomatic venous thromboembolism (VTE) to reduce the risk...
On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium for the treatment of symptomatic venous thromboembolism (VTE) to reduce the risk of recurrence in pediatric patients 1 month of age and older. Approval was primarily based on FDA review of a single-arm trial evaluating dalteparin administered subcutaneous twice daily in 38 pediatric patients with symptomatic VTE. Efficacy was based on the achievement of therapeutic plasma anti-Xa levels. The FDA concluded that dalteparin has efficacy and acceptable safety for pediatric patients.
Topics: Adolescent; Adult; Anticoagulants; Child; Child, Preschool; Dalteparin; Drug Approval; Female; Follow-Up Studies; Humans; Infant; Infant, Newborn; Male; Prognosis; United States; United States Food and Drug Administration; Venous Thromboembolism; Young Adult
PubMed: 32896942
DOI: 10.1002/pbc.28688