PMID- 22008390
OWN - NLM
STAT- MEDLINE
DCOM- 20120327
LR  - 20230829
IS  - 1538-7836 (Electronic)
IS  - 1538-7836 (Linking)
VI  - 9
IP  - 12
DP  - 2011 Dec
TI  - Incidence of thrombotic and bleeding complications during cardiac catheterization 
      in children: comparison of high-dose vs. low-dose heparin protocols.
PG  - 2353-60
LID - 10.1111/j.1538-7836.2011.04539.x [doi]
AB  - BACKGROUND: During cardiac catheterization (CC) in children, unfractionated 
      heparin (UFH) is used for primary prophylaxis of thrombotic events (TE). However, 
      the optimal UFH dose to minimize TE and bleeding in children has yet to be 
      established. OBJECTIVES: To (i) objectively assess the incidence of TE and 
      bleeding during pediatric CC using clinical assessment and ultrasound; and (ii) 
      compare a high-dose vs. low-dose UFH protocol for thromboprophylaxis. METHODS: A 
      randomized controlled trial (RCT) comparing high-dose UFH (100 units kg(-1) 
      bolus, followed by 20 units kg h(-1) continuous infusion) vs. low-dose UFH (50 
      units kg(-1) bolus) during CC. Outcome assessment was by clinical examination and 
      vascular ultrasound, performed by blinded examiners before and within 48 h after 
      CC. Children with no consent for randomization were followed in a cohort 
      receiving standard-of-care UFH (parallel-cohort RCT). RESULTS: A total of 227 
      children were included; 137 were randomized and 90 followed in the cohort study. 
      The overall incidence of TE was 4.6% and bleeding 6.6%. The RCT was stopped early 
      for futility as there were no differences between the high-dose and the low-dose 
      UFH in TE (5% vs. 3%; risk ratios [RR] 1.5, 95% confidence interval [CI] 0.3; 9) 
      and bleeding (7% vs. 12%, RR 0.6, 95% CI 0.2; 2). There were also no differences 
      when RCT and cohort study populations were combined. CONCLUSIONS: The incidences 
      of TE and bleeding during CC in children were low. There were no differences 
      between the high-dose and the low-dose UFH protocols studied. 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.
CI  - (c) 2011 International Society on Thrombosis and Haemostasis.
FAU - Hanslik, A
AU  - Hanslik A
AD  - Division of Paediatric Cardiology, Department of Paediatrics and Adolescent 
      Medicine Division of Angiology, Department of Internal Medicine II, Medical 
      University of Vienna, Vienna, Austria.
FAU - Kitzmuller, E
AU  - Kitzmuller E
FAU - Thom, K
AU  - Thom K
FAU - Haumer, M
AU  - Haumer M
FAU - Mlekusch, W
AU  - Mlekusch W
FAU - Salzer-Muhar, U
AU  - Salzer-Muhar U
FAU - Michel-Behnke, I
AU  - Michel-Behnke I
FAU - Male, C
AU  - Male C
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - J Thromb Haemost
JT  - Journal of thrombosis and haemostasis : JTH
JID - 101170508
RN  - 9005-49-6 (Heparin)
SB  - IM
MH  - *Blood Loss, Surgical
MH  - Cardiac Catheterization/*adverse effects
MH  - Child, Preschool
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Heparin/*adverse effects
MH  - Humans
MH  - Incidence
MH  - Infant
MH  - Male
MH  - Thrombosis/*etiology
EDAT- 2011/10/20 06:00
MHDA- 2012/03/28 06:00
CRDT- 2011/10/20 06:00
PHST- 2011/10/20 06:00 [entrez]
PHST- 2011/10/20 06:00 [pubmed]
PHST- 2012/03/28 06:00 [medline]
AID - S1538-7836(22)07485-2 [pii]
AID - 10.1111/j.1538-7836.2011.04539.x [doi]
PST - ppublish
SO  - J Thromb Haemost. 2011 Dec;9(12):2353-60. doi: 10.1111/j.1538-7836.2011.04539.x.