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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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Appendix 2Additional tables and figures

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TABLE 17

Recruitment by study site

Baseline characteristics for different subgroups

TABLE 18

Baseline characteristics, by cryoprecipitate timing: data are number/total number (%) for categorical variables, and median (IQR) for continuous variables

Standard care arm (n = 805)Intervention armOverall (n = 1604)
EC < 45 (n = 101)EC 46–60 (n = 147)EC 61–90 (n = 273)EC ≥ 90 (n = 128)EC unknown (n = 150)
Subjects
Male633/796 (80)81/101 (80)115/147 (78)218/273 (80)97/128 (76)107/136 (79)1251/1581 (79)
Age (years)40 (26–55)41 (28–52)34 (24–53)39 (26–55)37 (25–55)41 (27–58)39 (26–55)
Time from injury to admission to emergency department (minutes)77 (55–100)89 (69–107)76 (56–100)72 (52–96)70 (53–91)83 (60–104)76 (55–100)
Injuries and physiology at admission to emergency department
Blunt injury519/796 (65)60/101 (59)87/147 (59)174/273 (64)82/128 (64)92/136 (68)1014/1581 (64)
ISS29 (18–43)33 (17–43)29 (17–45)29 (17–43)29 (18–43)27 (16–42)29 (18–43)
Head AIS ≥ 4191/664 (29)20/82 (24)32/132 (24)47/235 (20)24/111 (22)34/105 (32)348/1329 (26)
Systolic blood pressure (mmHg)103 (83–126)98 (78–121)104 (80–126)99 (84–122)104 (84–126)107 (92–130)103 (83–125)
Heart rate (per minute)108 (88–127)110 (91–130)110 (92–128)109 (86–128)108 (85–125)103 (85–121)108 (88–127)
In cardiac arrest17/735 (2)3/88 (3)2/132 (2)3/252 (1)2/122 (2)2/123 (2)29/1452 (2)
Glasgow Coma Scale score13 (3–15)3 (3–14)12 (3–14)14 (3–15)15 (7–15)12 (3–15)14 (3–15)
Pre hospital
RBC (units)0 (0–2)1 (0–2)0 (0–2)0 (0–1)0 (0–1)0 (0–1)0 (0–2)
FFP (units)0 (0–1)0 (0–2)0 (0–1)0 (0–1)0 (0–0)0 (0–1)0 (0–1)
Crystalloids (ml)0 (0–250)0 (0–300)0 (0–350)0 (0–250)0 (0–250)0 (0–300)0 (0–250)
Colloids (ml)0 (0–0)0 (0–0)0 (0–0)0 (0–0)0 (0–0)0 (0–0)0 (0–0)
TXA administered639/796 (80)86/100 (86)118/147 (80)209/272 (77)92/128 (72)110/136 (81)1254/1579 (79)

EC, early cryoprecipitate; TXA, tranexamic acid.

Note

Summary of missing data: data on all characteristics were missing for 23 participants. In addition, ISS, cardiac arrest and blood pressure were missing for 246, 129 and 119 participants, respectively. There were a small number of missing data for other items.

TABLE 19

Baseline characteristics, by injury type: data are number/total number (%) for categorical variables, and median (IQR) for continuous variables

BluntPenetratingOverall (n = 1604)
Standard care arm (n = 519)Intervention arm (n = 495)Standard care arm (n = 277)Intervention arm (n = 290)
Subjects
Male384/519 (74)355/495 (72)249/277 (90)263/290 (91)1251/1581 (79)
Age (years)46 (30–60)46 (30–60)30 (22–43)30 (22–42)39 (26–55)
Time from injury to admission to emergency department (minutes)88 (67–108)84 (66–106)57 (44–78)59 (41–83)76 (55–100)
Injuries and physiology at admission to emergency department
Blunt injury519/519 (100)495/495 (100)0/277 (0)0/290 (0)1014/1581 (64)
ISS38 (27–50)36 (26–48)18 (11–26)17 (10–26)29 (18–43)
Head AIS ≥ 4176/453 (39)143/437 (33)15/211 (7)14/228 (6)348/1329 (26)
Systolic blood pressure (mmHg)104 (82–128)100 (84–125)102 (84–126)104 (84–124)103 (83–125)
Heart rate (per minute)107 (88–126)108 (89–126)109 (87–129)107 (87–128)108 (88–127)
In cardiac arrest9/479 (2)7/453 (2)8/256 (3)5/264 (2)29/1452 (2)
Glasgow Coma Scale score6 (3–15)12 (3–15)15 (11–15)14 (8–15)14 (3–15)
Pre hospital
RBC (units)0 (0–2)0 (0–2)0 (0–1)0 (0–1)0 (0–2)
FFP (units)0 (0–1)0 (0–1)0 (0–1)0 (0–1)0 (0–1)
Crystalloids (ml)0 (0–250)0 (0–300)0 (0–100)0 (0–100)0 (0–250)
Colloids (ml)0 (0–0)0 (0–0)0 (0–0)0 (0–0)0 (0–0)
TXA administered439/519 (85)406/495 (82)200/277 (72)209/288 (73)1254/1579 (79)

TXA, tranexamic acid.

Note

Summary of missing data: data on all characteristics were missing for 23 participants. In addition, ISS, cardiac arrest and blood pressure were missing for 246, 129 and 119 participants, respectively. There were a small number of missing data for other items.

Sensitivity analyses

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TABLE 20

Risk-adjusted multivariable marginal model for all-cause mortality at 28 days

FIGURE 12. Risk-adjusted OR by participant age, relative to a baseline participant at age 40 years.

FIGURE 12

Risk-adjusted OR by participant age, relative to a baseline participant at age 40 years.

FIGURE 13. Risk-adjusted OR by systolic blood pressure, relative to a baseline participant with systolic blood pressure of 100 mmHg.

FIGURE 13

Risk-adjusted OR by systolic blood pressure, relative to a baseline participant with systolic blood pressure of 100 mmHg.

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TABLE 21

Exclusions from per-protocol cohort, by treatment arm: n/N (%)

FIGURE 14. Forest plot of ORs and CIs for main ITT and per-protocol analyses of the primary outcome, subgroup analyses and sensitivity analyses.

FIGURE 14

Forest plot of ORs and CIs for main ITT and per-protocol analyses of the primary outcome, subgroup analyses and sensitivity analyses.

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TABLE 22

All-cause mortality at 28 days in the standard care arm and the intervention arm for those who did or did not receive any cryoprecipitate

FIGURE 15. Kaplan–Meier survival plot up to 28 days from admission by treatment arm and whether or not any cryoprecipitate given.

FIGURE 15

Kaplan–Meier survival plot up to 28 days from admission by treatment arm and whether or not any cryoprecipitate given.

Subgroup analyses

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TABLE 23

All-cause mortality at 28 days by treatment arm: UK participants vs. US participants

FIGURE 16. Kaplan–Meier survival plots up to 28 days from admission by treatment arm for (a) UK and (b) USA.

FIGURE 16

Kaplan–Meier survival plots up to 28 days from admission by treatment arm for (a) UK and (b) USA.

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TABLE 24

All-cause mortality at 28 days by treatment arm: head AIS < 4 vs. head AIS ≥ 4

FIGURE 17. Kaplan–Meier survival plots up to 28 days from admission by treatment arm for (a) head AIS < 4 and (b) head AIS ≥ 4.

FIGURE 17

Kaplan–Meier survival plots up to 28 days from admission by treatment arm for (a) head AIS < 4 and (b) head AIS ≥ 4.

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TABLE 25

All-cause mortality at 28 days by treatment arm: participant sex

FIGURE 18. Kaplan–Meier survival plots up to 28 days from admission by treatment arm for (a) male and (b) female patients.

FIGURE 18

Kaplan–Meier survival plots up to 28 days from admission by treatment arm for (a) male and (b) female patients.

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TABLE 26

All-cause mortality at 28 days by treatment arm: participant age < 70 vs. ≥ 70 years

FIGURE 19. Kaplan–Meier survival plots up to 28 days from admission by treatment arm for (a) age < 70 and (b) age ≥ 70 years.

FIGURE 19

Kaplan–Meier survival plots up to 28 days from admission by treatment arm for (a) age < 70 and (b) age ≥ 70 years.

Secondary outcomes

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TABLE 27

Mortality data

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TABLE 28

Transfusion requirements

FIGURE 20. Box-and-whisker plots to summarise transfusions administered from injury up to 24 hours from admission, by treatment arm.

FIGURE 20

Box-and-whisker plots to summarise transfusions administered from injury up to 24 hours from admission, by treatment arm. (a) RBC; (b) platelets; (c) FFP; (d) cryoprecipitate; (e) total blood products; and (f) crystalloids. These box-and-whisker plots show the median (line inside box), IQR (boundary of box), mean (diamond), minimum and maximum (whiskers) and outliers (values 1.5 × IQR above Q3 or below Q1). Extreme outliers for all products, defined as the top 1% of data, were excluded from these plots. Note the differing y-axes for each product.

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TABLE 29

Quality of life at discharge and 6 months after admission

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TABLE 30

Hospital stay

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TABLE 31

All-cause mortality at 6 and 12 months by treatment arm

Image 15-57-02_fig9
Image 15-57-02_fig10
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.

Bookshelf ID: NBK609199
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