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Curry N, Davenport R, Thomas H, et al. Early high-dose cryoprecipitate to reduce mortality in adult patients with traumatic haemorrhage: the CRYOSTAT-2 RCT with cost-effectiveness analysis. Southampton (UK): National Institute for Health and Care Research; 2024 Nov. (Health Technology Assessment, No. 28.76.)

Cover of Early high-dose cryoprecipitate to reduce mortality in adult patients with traumatic haemorrhage: the CRYOSTAT-2 RCT with cost-effectiveness analysis

Early high-dose cryoprecipitate to reduce mortality in adult patients with traumatic haemorrhage: the CRYOSTAT-2 RCT with cost-effectiveness analysis.

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References

1.
GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet 2020;396:1204–22. 10.1016/S0140-6736(20)30925-9 [PMC free article: PMC7567026] [PubMed: 33069326] [CrossRef]
2.
Kalkwarf KJ, Drake SA, Yang Y, Thetford C, Myers L, Brock M, et al. Bleeding to death in a big city: an analysis of all trauma deaths from hemorrhage in a metropolitan area during 1 year. J Trauma Acute Care Surg 2020;89:716–22. 10.1097/TA.0000000000002833 [PubMed: 32590562] [CrossRef]
3.
Cole E, Weaver A, Gall L, West A, Nevin D, Tallach R, et al. A decade of damage control resuscitation: new transfusion practice, new survivors, new directions. Ann Surg 2021;273:1215–20. 10.1097/SLA.0000000000003657 [PubMed: 31651535] [CrossRef]
4.
Moore EE, Moore HB, Kornblith LZ, Neal MD, Hoffman M, Mutch NJ, et al. Trauma-induced coagulopathy. Nat Rev Dis Primers 2021;7:30. [Erratum published in Nat Rev Dis Primers 2022;8:25.] 10.1038/s41572-021-00264-3 [PMC free article: PMC9115853] [PubMed: 35459275] [CrossRef]
5.
Khan S, Allard S, Weaver A, Barber C, Davenport R, Brohi K. A major haemorrhage protocol improves the delivery of blood component therapy and reduces waste in trauma massive transfusion. Injury 2013;44:587–92. 10.1016/j.injury.2012.09.029 [PubMed: 23127727] [CrossRef]
6.
Duchesne JC, Islam TM, Stuke L, Timmer JR, Barbeau JM, Marr AB, et al. Hemostatic resuscitation during surgery improves survival in patients with traumatic-induced coagulopathy. J Trauma 2009;67:33–7; discussion 37. 10.1097/TA.0b013e31819adb8e [PubMed: 19590305] [CrossRef]
7.
Johansson PI, Oliveri RS, Ostrowski SR. Hemostatic resuscitation with plasma and platelets in trauma. J Emerg Trauma Shock 2012;5:120–5. 10.4103/0974-2700.96479 [PMC free article: PMC3391834] [PubMed: 22787340] [CrossRef]
8.
Roberts I, Shakur H, Afolabi A, Brohi K, Coats T, Dewan Y, et al.; CRASH-2 Collaborators. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet 2011;377:1096–101, 1101.e1–2. 10.1016/S0140-6736(11)60278-X [PubMed: 21439633] [CrossRef]
9.
Hallet J, Lauzier F, Mailloux O, Trottier V, Archambault P, Zarychanski R, Turgeon AF. The use of higher platelet: RBC transfusion ratio in the acute phase of trauma resuscitation: a systematic review. Crit Care Med 2013;41:2800–11. 10.1097/CCM.0b013e31829a6ecb [PubMed: 23982024] [CrossRef]
10.
Stanworth SJ, Davenport R, Curry N, Seeney F, Eaglestone S, Edwards A, et al. Mortality from trauma haemorrhage and opportunities for improvement in transfusion practice. Br J Surg 2016;103:357–65. 10.1002/bjs.10052 [PubMed: 26841720] [CrossRef]
11.
Winearls J, Reade MC, McQuilten Z, Curry N. Fibrinogen in traumatic haemorrhage. Curr Opin Anaesthesiol 2021;34:514–20. 10.1097/ACO.0000000000001027 [PubMed: 34091461] [CrossRef]
12.
Chapin JC, Hajjar KA. Fibrinolysis and the control of blood coagulation. Blood Rev 2015;29:17–24. 10.1016/j.blre.2014.09.003 [PMC free article: PMC4314363] [PubMed: 25294122] [CrossRef]
13.
Martini WZ. Coagulopathy by hypothermia and acidosis: mechanisms of thrombin generation and fibrinogen availability. J Trauma 2009;67:202–8; discussion 208. 10.1097/TA.0b013e3181a602a7 [PubMed: 19590336] [CrossRef]
14.
Rourke C, Curry N, Khan S, Taylor R, Raza I, Davenport R, et al. Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes. J Thromb Haemost 2012;10:1342–51. 10.1111/j.1538-7836.2012.04752.x [PubMed: 22519961] [CrossRef]
15.
Rossaint R, Afshari A, Bouillon B, Cerny V, Cimpoesu D, Curry N, et al. The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition. Crit Care 2023;27:80. 10.1186/s13054-023-04327-7 [PMC free article: PMC9977110] [PubMed: 36859355] [CrossRef]
16.
Stanworth SJ, Dowling K, Curry N, Doughty H, Hunt BJ, Fraser L, et al.; Transfusion Task Force of the British Society for Haematology. Haematological management of major haemorrhage: a British Society for Haematology Guideline. Br J Haematol 2022;198:654–67. 10.1111/bjh.18275 [PubMed: 35687716] [CrossRef]
17.
Grottke O, Mallaiah S, Karkouti K, Saner F, Haas T. Fibrinogen supplementation and its indications. Semin Thromb Hemost 2020;46:38–49. 10.1055/s-0039-1696946 [PubMed: 31574543] [CrossRef]
18.
Nascimento B, Levy JH, Tien H, Da Luz LT. Cryoprecipitate transfusion in bleeding patients. Can J Emerg Med 2020;22:S4–11. 10.1017/cem.2019.409 [PubMed: 33084562] [CrossRef]
19.
Jensen NH, Stensballe J, Afshari A. Comparing efficacy and safety of fibrinogen concentrate to cryoprecipitate in bleeding patients: a systematic review. Acta Anaesthesiol Scand 2016;60:1033–42. 10.1111/aas.12734 [PubMed: 27109179] [CrossRef]
20.
Morrow GB, Carlier MSA, Dasgupta S, Craigen FB, Mutch NJ, Curry N. Fibrinogen replacement therapy for traumatic coagulopathy: does the fibrinogen source matter? Int J Mol Sci 2021;22:2185. 10.3390/ijms22042185 [PMC free article: PMC7926643] [PubMed: 33671748] [CrossRef]
21.
Curry N, Rourke C, Davenport R, Beer S, Pankhurst L, Deary A, et al. Early cryoprecipitate for major haemorrhage in trauma: a randomised controlled feasibility trial. Br J Anaesth 2015;115:76–83. 10.1093/bja/aev134 [PubMed: 25991760] [CrossRef]
22.
Nascimento B, Callum J, Tien H, Peng H, Rizoli S, Karanicolas P, et al. Fibrinogen in the initial resuscitation of severe trauma (FiiRST): a randomized feasibility trial. Br J Anaesth 2016;117:775–82. 10.1093/bja/aew343 [PubMed: 27956676] [CrossRef]
23.
Innerhofer N, Treichl B, Rugg C, Fries D, Mittermayr M, Hell T, et al.; On Behalf of the Retic Study Group. First-line administration of fibrinogen concentrate in the bleeding trauma patient: searching for effective dosages and optimal post-treatment levels limiting massive transfusion-further results of the RETIC study. J Clin Med 2021;10:3930. 10.3390/jcm10173930 [PMC free article: PMC8432065] [PubMed: 34501379] [CrossRef]
24.
Curry N, Foley C, Wong H, Mora A, Curnow E, Zarankaite A, et al. Early fibrinogen concentrate therapy for major haemorrhage in trauma (E-FIT 1): results from a UK multi-centre, randomised, double blind, placebo-controlled pilot trial. Crit Care 2018;22:164. 10.1186/s13054-018-2086-x [PMC free article: PMC6006766] [PubMed: 29914530] [CrossRef]
25.
Ziegler B, Bachler M, Haberfellner H, Niederwanger C, Innerhofer P, Hell T, et al.; FIinTIC study group. Efficacy of prehospital administration of fibrinogen concentrate in trauma patients bleeding or presumed to bleed (FIinTIC): a multicentre, double-blind, placebo-controlled, randomised pilot study. Eur J Anaesthesiol 2021;38:348–57. 10.1097/EJA.0000000000001366 [PMC free article: PMC7969176] [PubMed: 33109923] [CrossRef]
26.
Early Cryoprecipitate in Major Trauma Haemorrhage: CRYOSTAT-2. URL: 10.1186/ISRCTN14998314 (accessed 6 March 2023). [CrossRef]
27.
Curry N, Davenport R, Lucas J, Deary A, Benger J, Edwards A, et al. The CRYOSTAT2 trial: the rationale and study protocol for a multi-centre, randomised, controlled trial evaluating the effects of early high-dose cryoprecipitate in adult patients with major trauma haemorrhage requiring major haemorrhage protocol activation. Transfus Med 2023;33:123–31. 10.1111/tme.12932 [PubMed: 36321753] [CrossRef]
28.
CRYOSTAT-2: A Multi-centre, Randomised, Controlled Trial Evaluating the Effects of Early High-dose Cryoprecipitate in Adult Patients with Major Trauma Haemorrhage Requiring Major Haemorrhage Protocol (MHP) Activation (Protocol). URL: https:​//fundingawards​.nihr.ac.uk/award/15/57/02 (17 June 2024). [PubMed: 36321753]
29.
O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979;35:549–56. 10.2307/2530245 [PubMed: 497341] [CrossRef]
30.
PANDO Network. Framework Agreement for Clinical Communication Tools for NHS Organisations. URL: https://hellopando​.com/nhs (accessed 5 March 2023).
31.
Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee. Guidelines for the Blood Transfusion and Tissue Transplantation Services in the UK. URL: www​.transfusionguidelines.org/red-book (accessed 5 March 2023).
32.
Fine JP, Gray RJ. A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc 1999;94:496–509. 10.2307/2670170 [CrossRef]
33.
Walsh TS, Stanworth S, Boyd J, Hope D, Hemmatapour S, Burrows H, et al. The Age of BLood Evaluation (ABLE) randomised controlled trial: description of the UK-funded arm of the international trial, the UK cost-utility analysis and secondary analyses exploring factors associated with health-related quality of life and health-care costs during the 12-month follow-up. Health Technol Assess 2017;21:1–118. 10.1186/s13054-018-2086-x [PMC free article: PMC5682573] [PubMed: 29067906] [CrossRef]
34.
National Institute for Health and Care Excellence. Guide to the Methods of Technology Appraisal. London: NICE; 2013. URL: www​.nice.org.uk/guidance​/pmg9/resources/guide-to-the-methods-of-technology-appraisal-2013 (accessed 4 March 2023). [PubMed: 27905712]
35.
Office for National Statistics. Inflation and Price Indices. Newport: Office for National Statistics; 2023. URL: www​.ons.gov.uk/economy​/inflationandpriceindices (accessed 4 March 2023).
36.
Agus A, Hulme C, Verghis RM, McDowell C, Jackson C, O’Kane CM, et al. Simvastatin for patients with acute respiratory distress syndrome: long-term outcomes and cost-effectiveness from a randomised controlled trial. Crit Care 2017;21:108. 10.1186/s13054-017-1695-0 [PMC free article: PMC5434552] [PubMed: 28511660] [CrossRef]
37.
38.
Campbell HE, Stokes EA, Bargo DN, Curry N, Lecky FE, Edwards A, et al. Quantifying the healthcare costs of treating severely bleeding major trauma patients: a national study for England. Crit Care 2015;19:276. 10.1186/s13054-015-0987-5 [PMC free article: PMC4517367] [PubMed: 26148506] [CrossRef]
39.
CRYOSTAT-2. CRF Datasheet, Used to Infer Health Economic Results.
40.
EuroQol Group. EQ-5D-5L Quality of Life Questionnaire. URL: https://euroqol​.org/eq-5d-instruments​/eq-5d-5l-about/ (accessed 4 March 2023).
41.
Improve Trial Investigators. Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial. Eur Heart J 2015;36:2061–9. 10.1093/eurheartj/ehv125 [PMC free article: PMC4553715] [PubMed: 25855369] [CrossRef]
42.
van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health 2012;15:708–15. 10.1016/j.jval.2012.02.008 [PubMed: 22867780] [CrossRef]
43.
van Buuren S, Boshuizen HC, Knook DL. Multiple imputation of missing blood pressure covariates in survival analysis. Stat Med 1999;18:681–94. 10.1002/(SICI)1097-0258(19990330)18:6<681::AID-SIM71>3.0.CO;2-R [PubMed: 10204197] [CrossRef]
44.
Brand J, van Buuren S, le Cessie S, van den Hout W. Combining multiple imputation and bootstrap in the analysis of cost-effectiveness trial data. Stat Med 2019;38:210–20. 10.1002/sim.7956 [PMC free article: PMC6585698] [PubMed: 30207407] [CrossRef]
45.
Barber J, Thompson S. Multiple regression of cost data: use of generalised linear models. J Health Serv Res Policy 2004;9:197–204. 10.1258/1355819042250249 [PubMed: 15509405] [CrossRef]
46.
Baksaas-Aasen K, Gall LS, Stensballe J, Juffermans NP, Curry N, Maegele M, et al. Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial. Intensive Care Med 2021;47:49–59. 10.1007/s00134-020-06266-1 [PMC free article: PMC7550843] [PubMed: 33048195] [CrossRef]
47.
NCT05449834. FEISTY II (Fibrinogen Early In Sever Trauma StudY-2). URL: www​.feisty.org.au/ (accessed 28 February 2023).
48.
Hikida Y, Sumikura H, Okada H, Fujino T, Tanaka M, Sakai Y, et al. The value of the portable fibrinogen measuring device – a case report of severe postpartum hemorrhage with obstetric disseminated intravascular coagulation. JA Clin Rep 2021;7:23. 10.1186/s40981-021-00426-y [PMC free article: PMC7943675] [PubMed: 33687590] [CrossRef]
49.
Brenner A, Belli A, Chaudhri R, Coats T, Frimley L, Jamaluddin SF, et al.; CRASH-3 trial collaborators. CRASH-3 trial collaborators. Understanding the neuroprotective effect of tranexamic acid: an exploratory analysis of the CRASH-3 randomised trial. Crit Care 2020;24:560. 10.1186/s13054-020-03243-4 [PMC free article: PMC7657351] [PubMed: 33172504] [CrossRef]
50.
Morrow GB, Feller T, McQuilten Z, Wake E, Ariëns RAS, Winearls J, et al. Cryoprecipitate transfusion in trauma patients attenuates hyperfibrinolysis and restores normal clot structure and stability: results from a laboratory sub-study of the FEISTY trial. Crit Care 2022;26:290. 10.1186/s13054-022-04167-x [PMC free article: PMC9511733] [PubMed: 36163263] [CrossRef]
51.
Crombie N, Doughty HA, Bishop JRB, Desai A, Dixon EF, Hancox JM, et al.; RePHILL collaborative group. Resuscitation with blood products in patients with trauma-related haemorrhagic shock receiving prehospital care (RePHILL): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Haematol 2022;9:e250–61. 10.1016/S2352-3026(22)00040-0 [PMC free article: PMC8960285] [PubMed: 35271808] [CrossRef]
52.
Collins PW, Lilley G, Bruynseels D, Laurent DB, Cannings-John R, Precious E, et al. Fibrin-based clot formation as an early and rapid biomarker for progression of postpartum hemorrhage: a prospective study. Blood 2014;124:1727–36. 10.1182/blood-2014-04-567891 [PubMed: 25024304] [CrossRef]
53.
Cortet M, Deneux-Tharaux C, Dupont C, Colin C, Rudigoz RC, Bouvier-Colle MH, Huissoud C. Association between fibrinogen level and severity of postpartum haemorrhage: secondary analysis of a prospective trial. Br J Anaesth 2012;108:984–9. 10.1093/bja/aes096 [PubMed: 22490316] [CrossRef]
54.
De Lloyd L, Collins PW, Kaye A, Collis RE. Early fibrinogen as a predictor of red cell requirements during postpartum haemorrhage. Int J Obstet Anesth 2012;21:S13. URL: www​.obstetanesthesia​.com/article/S0959-289X(12)00045-3/pdf (accessed 28 February 2023).
55.
Wikkelsø AJ, Edwards HM, Afshari A, Stensballe J, Langhoff-Roos J, Albrechtsen C, et al.; FIB-PPH trial group. Pre-emptive treatment with fibrinogen concentrate for postpartum haemorrhage: randomized controlled trial. Br J Anaesth 2015;114:623–33. 10.1093/bja/aeu444 [PubMed: 25586727] [CrossRef]
56.
Green L, Knight M, Seeney FM, Hopkinson C, Collins PW, Collis RE, et al. The epidemiology and outcomes of women with postpartum haemorrhage requiring massive transfusion with eight or more units of red cells: a national cross-sectional study. BJOG 2016;123:2164–70. 10.1111/1471-0528.13831 [PubMed: 26694742] [CrossRef]
57.
Collins PW, Cannings-John R, Bruynseels D, Mallaiah S, Dick J, Elton C, et al. Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial. Br J Anaesth 2017;119:411–21. 10.1001/jama.2019.17312 [PubMed: 28969312] [CrossRef]
58.
Callum J, Farkouh ME, Scales DC, Heddle NM, Crowther M, Rao V, et al.; FIBRES Research Group. Effect of fibrinogen concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery: the FIBRES Randomized Clinical Trial. JAMA 2019;322:1966–76. [PMC free article: PMC6822637] [PubMed: 31634905]
Copyright © 2024 Curry et al.

This work was produced by Curry et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

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