Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients

Summary

Participation Requirements

Description

Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group): Cryoprecipitate group (dose: 10 ml/kg; active control group) or Fibrinogen Concentrate group (dose: 70 mg/kg; intervention group). There will be no ...

Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group): Cryoprecipitate group (dose: 10 ml/kg; active control group) or Fibrinogen Concentrate group (dose: 70 mg/kg; intervention group). There will be no placebo group since withholding treatment is neither consistent with standard of care nor acceptable ethically. No other aspects of care will be modified. In the event that an additional dose of fibrinogen supplementation is required (bleeding with documented hypofibrinogenemia) cryoprecipitate will be administered to all study subjects (including those who initially received FC). Data to be obtained: Demographic/preoperative data: age in days/months (all participants to be 24 months of age or younger) gender weight preoperative diagnosis RACHS classification surgery type & date (Norwood, arterial switch, truncus arteriosus, Glenn, anomalous pulmonary venous return, AV canal, tetralogy of Fallot, VSD closure, etc) preoperative PT/INR/aPTT/hemoglobin level/ hematocrit/ platelet count/ WBC count/ fibrinogen level (Clauss method) metabolic panel (sodium, BUN, creatinine, glucose, calcium, bicarbonate, Liver function tests) Intra-operative Data: CPB time & aortic cross clamp time Use of hypothermic circulatory arrest (ice packs placed on the head) ROTEM: Extem (CT/A10/A20/MCF) and Fibtem (A10/A20/MCF) at the following time points: baseline (after induction of anesthesia), 20 min prior to separation from CPB and 10 minutes after completion of fibrinogen concentrate/cryoprecipitate administration Platelet count prior to separation from CPB was ATIII administered? (thrombate) Transfusion requirements: PRBC/Cell Saver/FFP/PLT/ cryoprecipitate - to be collected as number of units per each product, not volume. (for PLT - was it pooled PLT or single donor apheresis) was rFVIIa given (factor seven, novoseven). Need for ECMO support after separation trial from CPB Was the chest left open? Postoperative Data PT/aPTT/INR/platelet count/ fibrinogen level/ Hgb level/HCT level on admission to the ICU ROTEM parameters Liver and kidney function tests on admission to the ICU Bleeding (Chest drain output until 48 hours after surgery) Need for additional transfusion (RBC/FFP/platelets/cryoprecipitate) until 7 days after surgery. Factor VIIa administration re-exploration for bleeding/tamponade (need for postoperative chest re-exploration or re- operation either in the ICU or in the OR due to excessive postoperative bleeding and/or cardiac tamponade) Need for initiation of ECMO support in the ICU postoperatively Duration of postoperative intubation AKI (AKIN criteria) Stroke/seizures > 24 hours post-operatively Infection (sternal wound infection/mediastinitis/pneumonia/sepsis) Thromboembolic complications (shunt thrombosis/DVT/PE) ICU length of stay Hospital length of stay In hospital mortality

Tracking Information