Optimal antithrombotic regimen in patients with cardiogenic shock on ImpellaTM mechanical support: less might be more

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Vandenbriele ◽  
L Dannenberg ◽  
M Monteagudo-Vela ◽  
T Balthazar ◽  
D Metzen ◽  
...  
Keyword(s):  
Cardiogenic Shock ◽  
Low Dose ◽  
Cox Regression ◽  
Mechanical Support ◽  
Bleeding Events ◽  
Heparin Group ◽  
Cox Regression Analysis ◽  
Dose Heparin ◽  
Low Dose Heparin ◽  
Ischemic Events

Abstract Background Bleeding and ischemic complications are the main cause of morbidity and mortality in critically ill cardiogenic shock patients, supported by short-term percutaneous mechanical circulatory support (pMCS) devices. Hence, finding the optimal antithrombotic regimen is challenging. Bleeding not only occurs because of heparin and antiplatelet therapy (both required in the prevention of pump and acute stent thrombosis) but also because of device- and disease related coagulopathy. To prevent clotting-related device failure, most centers target full therapeutic heparin anticoagulation levels in left ventricular (LV) Impella™ supported patients in analogy with Veno-Arterial Extracorporeal Membrane Oxygenation. We aimed to investigate the safety (related to bleeding and thrombotic complications) of targeting low-dose versus therapeutic heparin levels in left Impella™-supported cardiogenic shock patients on dual antiplatelet therapy (DAPT). Methods In this hypothesis generating pilot study, we investigated 114 patients supported for at least two days by LV Impella™ mechanical support due to cardiogenic shock at three tertiary ICUs, highly specialized in mechanical support. Low-dose heparin (aPTT 40–60s or anti-Xa 0.2–0.3) was compared to standard of care (aPTT 60–80s or anti-Xa 0.3–0.5). Major adverse cardio- and cerebrovascular events (MACCE; composite of death, myocardial infarction, stroke/transient ischemic attack) and BARC bleeding (bleeding academic research consortium classification) during 30 day follow-up were assessed. Inverse probability of treatment weighting (IPTW) analysis was calculated with age, gender, arterial hypertension, diabetes mellitus, smoking, chronic kidney disease, previous stroke, previous myocardial infarction, previous coronary arterial bypass grafting, hypercholesterolemia and DAPT as matching variables. COX regression analysis was conducted to test for robustness. Results IPTW revealed 52 patients in the low-dose heparin group and 62 patients in the therapeutic group. Mean age of patients after IPTW was 62±16 years in the intermediate and 62±13 years in the therapeutic group (p=0.99). 25% and 42.2% were male (p=0.92). Overall bleeding events and major (BARC3b) bleeding events were higher in the therapeutic heparin group (overall bleeding: Hazard ratio [HR]=2.58, 95% confidence interval [CI] 1.2–5.5; p=0.015; BARC 3b: HR=4.4, 95% CI 1.4–13.6, p=0.009). Minor bleeding (BARC3a) as well as MACCE and its single components (ischemic events) did not differ between both groups. These findings were robust in the COX regression analysis. Conclusion In this pilot analysis, low-dose heparin in 114 LV Impella™ cardiogenic shock patients was associated with less bleeding without increased ischemic events, adjusted for DAPT. Reducing the target heparin levels in critically ill patients supported by LV Impella™ might improve the outcome of this precarious group. These findings need to be validated in randomized clinical trials. Funding Acknowledgement Type of funding source: None

Low Dose Heparin Versus Oral Anticoagulants in the Prevention of Postoperative Venous Thrombosis in Gynecology

1975 ◽  
Author(s):  
A. E. Schaer ◽  
L. Huber ◽  
P. Bader ◽  
U. Baertschi ◽  
P. Morf
Keyword(s):  
Low Dose ◽  
Oral Anticoagulants ◽  
Randomised Trial ◽  
Postoperative Hemorrhage ◽  
Heparin Group ◽  
Vein Thrombosis ◽  
Dose Heparin ◽  
Severe Hemorrhage ◽  
Fibrinogen Test ◽  
Low Dose Heparin

In a randomised trial involving 458 patients low dose heparin, peri- and postoperatively given subcutaneousely (Liquemin subcutan Roche) 2 × 5000 U twice daily for one week, was compared with oral anticoagulants. Deep vein thrombosis, diagnosed clinically and by the 125-J-fibrinogen test, was less frequent in the heparin group (2,3%/4,6%). However, the incidence of pulmonary embolism was rather high (6 cases in the heparin group, only one with oral anticoagulants). Mild postoperative hemorrhage occured more often with heparin, but the incidence of severe hemorrhage remained the same (4,5%).These results suggest to examine a combination of the two methods: low dose heparin perioperatively, oral anticoagulants in the postoperative course.

Drcg Phopllylaxis of Thromboehbolic Complicatioxs, Lituts and Facilities in Hip Surgery

1979 ◽  
Author(s):  
K. Westermann ◽  
O. Trentz ◽  
P. Pretschmer
Keyword(s):  
Hip Replacement ◽  
Low Dose ◽  
Lung Perfusion ◽  
Pulmonary Emboli ◽  
Thromboembolic Complications ◽  
Heparin Group ◽  
Dose Heparin ◽  
Before And After ◽  
Perfusion Scan ◽  
Low Dose Heparin

In 1973 we started prospective, controlled trials on prophylactic efficiency of 5 drugs: combination of aspirin and dipyridaMol (95 patients), deXtran 60 (43 patients), Clihydroergotarnin (61patients), Iml-dose-heparin (63 patients) and a combination of dihydroergotamin and low-dose-heparin two times (61patients), three times (63 patients) a day. The 386 patients undergoing total hip replacement were screened with the 125-J-fibrinogenuptake- test, phlebography and a careful clinical evaluation before and after surgery. A lung perfusion scan was performed in the last 4 groups. In cases of established DVT simultaneous anticoagulation with heparin and coumarin was started. In the group with aspirin/dipyridamol prophylaxis 32 (34 %) DVT and 3 pulmonary emboli were detected. In the dextran group 24 (56 %) got DVT and one non fatal PE. The dihydroergotamin showed 33 DVT (54 %) and 7 PE. In the low dose heparin group we had 29 (46 %) DVT and 3 PE. Only the combination of low dose heparin and dihydroergotamin reduced the incidence of thromboembolic complications significantly: no PE, 15 DVT (25%). The last group showed no further reduction but more hemorrhagic complications

scholarly journals Prevention of hepatic veno-occlusive disease after bone marrow transplantation by continuous infusion of low-dose heparin: a prospective, randomized trial [see comments]

Blood ◽  
1992 ◽  
Vol 79 (11) ◽  
pp. 2834-2840 ◽  
Author(s):  
M Attal ◽  
F Huguet ◽  
H Rubie ◽  
A Huynh ◽  
JP Charlet ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Bone Marrow Transplantation ◽  
Randomized Trial ◽  
Continuous Infusion ◽  
Marrow Transplantation ◽  
Low Dose ◽  
Control Group ◽  
Heparin Group ◽  
Dose Heparin ◽  
Low Dose Heparin

Abstract Hepatic veno-occlusive disease (VOD) is a major regimen-related toxicity after bone marrow transplantation (BMT). Endothelial injury, leading to deposition of coagulation factors within the terminal hepatic venules, is believed to be the key event in the pathogenesis of VOD. To evaluate the benefit and the safety of a VOD prophylaxis with anticoagulants, we conducted a prospective randomized trial of continuous infusion of low-dose heparin among 161 patients under-going either allogeneic (n = 79) or autologous BMT (n = 81). Patients were randomized to receive (n = 81) or not receive (n = 80) prophylactic heparin 100 U/kg/d by continuous infusion from day -8 until day +30 post-BMT. Heparin was found to be highly effective in preventing VOD, which occurred in 11 of 80 patients (13.7%) in the control group versus 2 of 81 (2.5%) in the heparin group (P less than .01). Furthermore, none of the 39 patients in the heparin group developed VOD after allogeneic BMT, versus 7 of 38 (18.4%) in the control group (P less than .01). This prophylactic effect was achieved without added risk of bleeding. Indeed, the low-dose heparin we used did not prolong the partial thromboplastin time and did not increase the red blood cell and platelet requirements. It is therefore recommended that heparin prophylaxis be part of early mortality prevention programs after BMT.

FREVENTION OF MYOCARDIAL REINFARCTION BY LOW DOSE HEPARIN

1987 ◽  
Author(s):  
G G Neri Semeri ◽  
F Rovelli ◽  
G F Gensini ◽  
S Pirelli ◽  
M Carnovali ◽  
...  
Keyword(s):  
Life Table ◽  
Low Dose ◽  
Controlled Study ◽  
Control Group ◽  
Life Table Analysis ◽  
Heparin Group ◽  
End Points ◽  
Dose Heparin ◽  
Table Analysis ◽  
Low Dose Heparin

The effectiveness of low dose heparin in the prevention of myocardial reinfarction was investigated in a multi centric randomized controlled study. After having given their, informed consent to undergo daily subcutaneous heparin adninistratian, 728 patients of both sex aged 50-75 years, who had suffered frcm a transmural myocardial infarction 6-18 months before the enrollment and were in the I or II NYHA class were randomized. 365 patients (control group) were an the therapy usually performed by the 21 experimental canters participating in the study and 363 (heparin group) were treated with subcutaneous calcium heparin (Calciparina®) 12,500 IU daily in addition to the usual therapy of the centers. Curing enrollment the balancement of the two grcups was periodically checked for age, sex, serum cholesterol, cigarette smoking, blood pressure, site of infarction, arrhythmias and drug regimen. The prospect!vely established end-points were: transmural reinfarctioi as primary end-point; general mortality and mortality for cardiovascular events as accessory end-points over a mean follow-up period of 24 nxnths. Statistical analysis was foreseen both on drug efficacy (EE) and intention to treat (IT) basis. Patients of both groups underwent periodical examinations during the study. Acherence to the therapy and bone mineral content (bone density by double isotope technique) were also checked. At the end of the study the balancement for the factors considered was satisfactory and the drop-outs were 7.7% in heparin group and 6.3% in control group (ns). In heparin group the re infarction rate was lcwer by 62.92% than in control group. At life table analysis the difference was statistically significant (p<0.05 DE and p=0.05 IT). Mortality rate was reduced by 47.61% (DE) in heparin group (p<0.05 at life table analysis). Cardiovascular mortality was not significantly reduced (−33.06%), but the mortality attributable to thromboembolism was reduced in heparin group (p<0.05). Sixty patients (16.5%) discontinued heparin treatment, but only in 23 patients (6.3%) suspension was due to side effects.

scholarly journals LOW DOSE HEPARIN;

2012 ◽  
Vol 19 (02) ◽  
pp. 246-250
Author(s):  
ABID NAEEM ◽  
TAHIRA JABBAR
Keyword(s):  
Low Dose ◽  
Therapeutic Benefit ◽  
Cranial Computed Tomography ◽  
Control Group ◽  
Heparin Group ◽  
Dose Heparin ◽  
History Of ◽  
Study Setting ◽  
Low Dose Heparin ◽  
Better Than

Objective: To evaluate the therapeutic benefit of low dose heparin in cerebral venous thrombosis, occurring during period ofperpeurum. Study design: Descriptive study. Setting: Department of Medicine DHQ Hospital Mirpur (Department of Obs/Gynae DHQ HospitalMirpur(AK). Period: January 2010 to November 2011. Method: This study was carried on 100 patients with history of postpartum cerebralvenous thrombosis. Out of which 48 on heparin and 52 formed the control group. The ages of all patients were between 20 to 30 years.Parameter recorded included history. Blood pressure.,the diagnosis was supported by cranial computed tomography. The secondary causeswere ruled out on the basis of history and physical examination. The data and results were analyzed in SPSS. Results: Out of 48 patients inheparin group 30 with non-heamorrhage lesion and 18 with haemorrhagic infarction). 52 in control group. 34 non-haemorriagic lesion and 18with haemorragic infarct .in non-haemorrhagic CVT, there is no death in heparin group as compared to 5 deaths in control group. In patients withhaemorriagic lesions, there were 5 deaths in heparin group as compared to 7 deaths in the control group. Heparin faed better than the controlgroup, both in patients with haemorrhagic as well as non-haemorrhagic lesions. Conclusions: Low molecular weight (LMWH) at low doses issafe and effective for both non-haemorrhage and haemorrhgic infarct of postpartum cvt with regard to recovery and outcome as compared tocontrol group.

Low-Dose Heparin Or Aspirin-Dipyridimole In Prevention Of Postoperative Deep Venous Thrombosis

1981 ◽  
Author(s):  
J H Kennedy
Keyword(s):  
At Risk ◽  
Venous Thrombosis ◽  
General Anesthesia ◽  
Low Dose ◽  
Randomized Study ◽  
General Anaesthetic ◽  
Group Vi ◽  
Heparin Group ◽  
Dose Heparin ◽  
Low Dose Heparin

Venous thrombosis and pulmonary embolism remain a serious threat to postoperative patients. Kakker et al have reported favorable effects of low-dose heparin in a prospective study in 4,121 patients in 23 hospitals.In a prospective randomized study, between May 1978 and August 1980, 375 patients were collated into 7 groups 146 were excluded because of a contraindication to Heparin or lack of general anesthesia; those over 45 vho received a general anesthesia were given either 2,500 u Heparin with premedication and daily until discharge (Group V) or 1 Gram Aspirin-100 mgm Dipyridimole on the same schedule (Group VI); the remainder served as controls.The results supported protective treatment of over 45 who receive a general anaesthetic and surgery; in unteated patients there were 6 nonfatal thrombotic episodes in 1397 patient-days at risk, but none in either treatment group., together totalling 756 patient- days at risk for the Heparin group and 238 patient-days at risk for the Aspirin-Dipyridimole group.

Effect of Low-Dose heparin and dihydroercotamine prophylaxis on incidence of postoperative deep-vein thrombosis in patients undergoing hip surgery

1979 ◽  
Author(s):  
G. Lahnborg ◽  
B. Beerman
Keyword(s):  
Low Dose ◽  
Prospective Trial ◽  
Favourable Effect ◽  
Control Group ◽  
Heparin Group ◽  
Vein Thrombosis ◽  
Dose Heparin ◽  
Deep Vein ◽  
Low Dose Heparin ◽  
Heparin Prophylaxis

The favourable effect of low-dose heparin prophylaxis in preventing postoperative deep-vain thrombosis (DVT) in patients undergoing surgical treume has bean shown in several investigations. However, there are still some patients sustaining DVT in spite of heparin prophylaxis. In an attempt to improve the prophylaxis, dihydroergotamine (DHE) has been added to the heparin.In a prospective trial the effect of low-dose heparin and DHE prophylaxis was studied in 190 patients undergoing nailing of fractured femoral neck. The patients were divided into 3 groups and were randomly given heparin or a combination of heparin and DHE and the third group was given only saline.The frequency of DVT, detected by the 125-I-fibrinogen method was 167. in the group given heparin and DHE, 20%, in the heparin group and 39% in the control group.Preliminary results. Completed evaluation will be presented during the congress.

scholarly journals Prevention of hepatic veno-occlusive disease after bone marrow transplantation by continuous infusion of low-dose heparin: a prospective, randomized trial [see comments]

Blood ◽  
1992 ◽  
Vol 79 (11) ◽  
pp. 2834-2840 ◽  
Author(s):  
M Attal ◽  
F Huguet ◽  
H Rubie ◽  
A Huynh ◽  
JP Charlet ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Bone Marrow Transplantation ◽  
Randomized Trial ◽  
Continuous Infusion ◽  
Marrow Transplantation ◽  
Low Dose ◽  
Control Group ◽  
Heparin Group ◽  
Dose Heparin ◽  
Low Dose Heparin

Hepatic veno-occlusive disease (VOD) is a major regimen-related toxicity after bone marrow transplantation (BMT). Endothelial injury, leading to deposition of coagulation factors within the terminal hepatic venules, is believed to be the key event in the pathogenesis of VOD. To evaluate the benefit and the safety of a VOD prophylaxis with anticoagulants, we conducted a prospective randomized trial of continuous infusion of low-dose heparin among 161 patients under-going either allogeneic (n = 79) or autologous BMT (n = 81). Patients were randomized to receive (n = 81) or not receive (n = 80) prophylactic heparin 100 U/kg/d by continuous infusion from day -8 until day +30 post-BMT. Heparin was found to be highly effective in preventing VOD, which occurred in 11 of 80 patients (13.7%) in the control group versus 2 of 81 (2.5%) in the heparin group (P less than .01). Furthermore, none of the 39 patients in the heparin group developed VOD after allogeneic BMT, versus 7 of 38 (18.4%) in the control group (P less than .01). This prophylactic effect was achieved without added risk of bleeding. Indeed, the low-dose heparin we used did not prolong the partial thromboplastin time and did not increase the red blood cell and platelet requirements. It is therefore recommended that heparin prophylaxis be part of early mortality prevention programs after BMT.

Low-Dose Heparin in Critically Ill Patients Undergoing Extracorporeal Membrane Oxygenation - the Help-ECMO Pilot Randomised Controlled Trial

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3822-3822 ◽  
Author(s):  
Zoe McQuilten ◽  
Cecile Aubron ◽  
Michael Bailey ◽  
Jasmin Board ◽  
Heidi Buhr ◽  
...  
Keyword(s):  
Low Dose ◽  
Controlled Trial ◽  
Therapeutic Group ◽  
Heparin Dose ◽  
Bleeding Events ◽  
Dose Heparin ◽  
Therapeutic Anticoagulation ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Low Dose Heparin

Abstract Extra corporeal membrane oxygenation (ECMO) is a rescue therapy for reversible cardiac and/or respiratory failure. Despite improvement in management of patients undergoing ECMO, mortality remains high. Due to thrombosis risk, which includes arterial and venous thrombosis as well as in the extracorporeal circuit and components, variable intensity systemic anticoagulation with unfractionated heparin is routinely used. However, bleeding is one of the most frequent complications, can be severe and is independently associated with worse outcomes. Optimal anticoagulation to prevent thrombosis whilst minimising bleeding in adults on ECMO remains unknown. Before conducting a large randomised controlled trial to determine whether lower anticoagulation intensity is safe and effective compared with therapeutic anticoagulation, we aimed to determine the feasibility of randomising ECMO patients to these anticoagulation protocols. Methods: The HELP-ECMO pilot study (ACTRN12613001324707) is a randomised, controlled, unblinded trial at two Australian intensive care units (ICUs). Inclusion criteria were ICU patients who required ECMO (venous-venous [VV] or venous-arterial [VA]). Patients who did not meet any exclusion criteria were randomised to receive either therapeutic anticoagulation with heparin (target activated partial thromboplastin time [aPTT] between 50 and 70 seconds) or low dose heparin (12000 units/24 hours aiming for aPTT <45 seconds). Paired aPTT and anti-Xa assays were taken according to protocol, and at a minimum once a day. The primary endpoints for feasibility were difference in mean heparin dose, aPTT and anti-Xa levels between both study groups. Secondary endpoints included incidence of thromboembolic events, ECMO circuit thrombosis and bleeding events. All primary outcomes were log-transformed prior to analysis and reported as geometric means (95%CI) with overall differences determined using Repeat measures ANOVA. Results: Between May 2014 and March 2016, 31 patients who underwent ECMO (9 (29%) VA and 22 (71%) VV) were enrolled; 16 were randomised to low dose and 15 to therapeutic dose heparin. The groups were similar in age (mean 41 years [SD 16.8] vs 43 [SD 17.6] p=0.75), gender (68% vs 80% male, p=0.47), type of ECMO (31% vs 27% VA, p=0.78) and Acute Physiology and Chronic Health Evaluation III illness severity score (mean 65.4 [SD 23.5] vs 61.8 [SD 30.1], p=0.72) and sepsis-related organ failure assessment score (mean 10 [SD 3.6] vs 10 [SD 3.3], p=1.0). The mean duration of ECMO support was 9.33 days (SD 5.97) in the low dose and 9.79 days (SD 4.77) in the therapeutic dose group (p=0.82). For the primary outcomes, there was a significant difference in the daily mean aPTT (48.1 [95% CI 43.5-53.3] vs 56.2 [95% CI 50.7-62.3], p=0.03), daily mean anti-Xa (0.11 [95% CI 0.07-0.18] vs 0.30 [IQR 0.19-0.46], p=0.003) and daily mean heparin dose (11784 units [95% CI 8693-15972] vs 22050 [IQR 16262-29899], p=0.004) in the low dose compared to therapeutic group. There was no difference in thrombotic complications with regard to DVT (2 [12.5%] vs 3 [20%], p=0.57), PE (1 [6.3%] vs 0 [0%], p=0.33), stroke (no events), intracardiac thrombus (1 [6.3%] vs 2 [13.3%], p=0.51), acute pump (1 [6.3%] vs 1[6.7%], p=0.96) and distal perfusion cannula thrombosis (2 [12.5%] vs 0 [0%], p=0.16) in low dose compared with therapeutic group, respectively. With regard to bleeding, there was no difference in intracranial haemorrhage (ICH) (0 [0%] vs 1 [6.7%], p=0.29), retroperitoneal bleeding (1 [6.3%] vs 1 [6.7%], p=0.96), gastrointestinal bleeding (0 [0%] vs 2 [13.3%] , p=0.13), or haemoptysis (1 [6.5%] vs 1 [6.7%], p=0.96) in low dose compared with therapeutic group, respectively. Conclusion: In this pilot trial, administration of a low dose heparin protocol was feasible, and resulted in a significant difference in mean heparin dose administered and daily aPTT and anti-Xa levels between groups. Low dose heparin was not associated with an increase in thrombotic events nor a decrease in bleeding events; however the study was not powered for these outcomes. Our findings support the feasibility of a larger phase III study to evaluate the safety and efficacy of low-dose anticoagulation compared with therapeutic heparin with regard to thrombotic and bleeding events in patients receiving ECMO. Disclosures No relevant conflicts of interest to declare.

Low Molecular Weight Heparin and Prevention of Postoperative Thrombosis in Abdominal Surgery

1992 ◽  
Vol 67 (06) ◽  
pp. 627-630 ◽  
Author(s):  
K Koppenhagen ◽  
J Adolf ◽  
M Matthes ◽  
E Tröster ◽  
J D Roder ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Abdominal Surgery ◽  
Low Molecular Weight Heparin ◽  
Low Dose ◽  
Low Molecular Weight ◽  
Heparin Group ◽  
Vein Thrombosis ◽  
Dose Heparin ◽  
Deep Vein ◽  
Low Dose Heparin

SummaryIn a prospective, double-blind, randomized multicenter trial the efficacy and safety of low molecular weight heparin and unfractionated heparin were compared for the prevention of postoperative deep vein thrombosis in patients undergoing abdominal surgery. Six hundred and seventy-three patients were randomly allocated to the two prophylaxis groups; 20 of these, however, did not undergo surgery and did not receive any prophylaxis. Of the remaining 653 patients 323 received one subcutaneous injection of 3,000 anti-Xa units of low molecular weight heparin and 330 received subcutaneously 5,000 U heparin three times a day. Treatment was initiated 2 h preoperatively and continued for 7 to 10 days. The occurrence of DVT was determined by the 125I-labelled fibrinogen uptake test and phlebography. Venous thrombosis was diagnosed in 24 of 323 patients (7.4%) treated with low molecular weight heparin and in 26 of 330 patients (7.9%) treated with low-dose heparin. DVT of proximal veins was detected in four patients of the low molecular weight heparin group and in three patients of the low-dose heparin group. During the observation period three pulmonary emboli - one fatal and two non-fatal - occurred in patients receiving prophylaxis with low-dose heparin. No pulmonary embolism was found in patients treated with low molecular weight heparin. Both prophylactic schemes were well tolerated. Intra-and postoperative blood loss, incidence of wound hematoma, frequency and volume of intra- and postoperative blood transfusion were similar in both groups with a slight advantage for the low molecular weight heparin group. The results of this trial show that the investigated low molecular weight heparin is at least as effective and safe as low-dose heparin in preventing deep vein thrombosis in patients undergoing elective abdominal surgery.

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