Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients
Paraules clau
Resum
Descripció
Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group):
1. Cryoprecipitate group (dose: 10 ml/kg; active control group) or
2. 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:
1. 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)
2. 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?
3. 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
Dates
| Darrera verificació: | 04/30/2020 |
| Primer enviat: | 02/25/2020 |
| Inscripció estimada enviada: | 04/30/2020 |
| Publicat per primera vegada: | 05/05/2020 |
| Última actualització enviada: | 05/04/2020 |
| Publicació de l'última actualització: | 05/06/2020 |
| Data d'inici de l'estudi real: | 08/31/2020 |
| Data estimada de finalització primària: | 08/29/2021 |
| Data estimada de finalització de l’estudi: | 12/30/2021 |
Condició o malaltia
Intervenció / tractament
Drug: Fibrinogen Concentrate
Drug: Cryoprecipitate
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: Fibrinogen Concentrate Fibrinogen Concentrate (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). | Drug: Fibrinogen Concentrate Fibrinogen Concentrate (Human) Injection [Fibryga] (dose: 70 mg/kg; intervention group). in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
| Active Comparator: Cryoprecipitate . Cryoprecipitate (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). | Drug: Cryoprecipitate Cryoprecipitate group (dose: 10 ml/kg; active control group) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). |
Criteris d'elegibilitat
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: - pediatric (age 24 months or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF < 10 mm on the FIBTEM assay of ROTEM). Exclusion Criteria: - gestational age < 33 weeks at birth - gestational age < 35 weeks on the day of surgery - emergency surgery - patient or parent history of coagulopathy/clotting abnormalities - patient history of thrombophilia - refusal to participate in the study, - known severe allergic reaction/anaphylaxis to fibrinogen concentrate, - administration of fibrinogen concentrate or cryoprecipitate in the 24 hours prior to surgery - baseline fibrinogen level higher than 300 mg/dL (to avoid the risk of increasing the fibrinogen level above the normal upper level of 400 mg/dL) |
Resultat
Mesures de resultats primaris
1. A composite of the number of any allogeneic blood products (RBCs, plasma, platelets, cryoprecipitate) transfused from administration of the study medication until 48 hours after surgery [from immediately after the administration of the fibrinogen concentrate or cryoprecipitate through the first 48 hours after admission to the ICU/post anesthesia care unit]
Mesures de resultats secundaris
1. Comparison of post CPB bleeding (in ml) between the study groups [from administration of fibrinogen concentrate or cryoprecipitate until 48 hours after primary postoperative admission to the ICU]
2. Comparison of the number RBC units transfused immediately after administration of the study medication and until postoperative day 7 [From immediately after study medication administration through postoperative day 7]
3. Comparison of the number platelets units transfused immediately after administration of the study medication and until postoperative day 7 [From immediately after study medication administration through postoperative day 7]
4. Comparison of the number plasma units transfused immediately after administration of the study medication and until postoperative day 7 [From immediately after study medication administration through postoperative day 7]
5. Comparison of additional number cryoprecipitate units transfused immediately after administration of the study medication and until postoperative day 7 [From immediately after study medication administration through postoperative day 7]
6. Incidence of postoperative surgical chest re-exploration for excessive bleeding/cardiac tamponade [from admission to the ICU until postoperative day 7]
7. Incidence of the use of Factor VIIa for bleeding [from separation from CPB until 48 hours after surgery]
8. In-hospital mortality [from admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier)]
9. Post operative Acute Kidney injury (AKI) [from admission to the ICU until postoperative day 7]
10. Postoperative infection [rom admission to the ICU until 30 days after the operation/discharge from the hospital (whichever is earlier)]
11. percent of patients with postoperative neurological injury [from admission to the ICU until POD 7]
12. Intubation time [from admission to the ICU until 30 days after surgery or discharge from the ICU (whichever is earlier)]
13. postoperative thromboembolic event [from admission to the ICU until 7 days postoperatively]
14. ICU length of stay [from admission to the ICU after surgery until 90 days after surgery or discharge from the ICU (whichever occurs earlier)]
15. Hospital length of stay [from admission to the ICU postoperatively until postoperative day 90 or discharge from the hospital (whichever occurs earlier)]
Altres mesures de resultats
1. Percent of patients requiring postoperative Extra Corporeal Membrane Oxygenation (ECMO) support [from separation from CPB until postoperative day 30 (or discharge from the hospital (whichever occurs earlier)]
