A Single-center, Randomized, Placebo Controlled Pilot Study of Packed Red Blood Cell Transfusion During Prolonged Adult In-hospital Cardiac Arrest
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time (in mins) to administration of Packed Red Blood Cells (PRBC)
研究概览
简要总结
The purpose of this pilot interventional study is to collect preliminary data on administering packed red blood cell (PRBC) during cardiac arrest (CA). The primary objective is to assess the feasibility of PRBC transfusion during cardiac CA to help optimize the methods required to augment cerebral and other vital organ oxygen delivery during cardiopulmonary resuscitation (CPR). The secondary objectives are to assess the effect of PRBC transfusion during prolonged cardiac arrests on cerebral oxygenation, end tidal carbon dioxide (ETCO2), return of spontaneous circulation (ROSC), survival to discharge, biomarkers of neural injury and inflammation, and neurological outcomes at hospital discharge, 30 days post-CA, and 90 days post-CA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, age ≥18 and <85 years
- •Experience prolonged, non-trauma-related in-hospital cardiac arrest, defined by cessation of heartbeat and respiration requiring CPR for at least 10 minutes
排除标准
- •Age <18 years old
- •Age > 85 years old
- •Patients with DNR/DNI orders (Do Not Resuscitate/Do Not Intubate)
- •Patients admitted to the hospital with a cardiac arrest arising from trauma
- •Patients who achieve return of spontaneous circulation within 10 minutes of CPR
- •Inability to start study product administration within 20 minutes of cardiac arrest onset
- •Prisoners
- •Women who are known to be pregnant
- •Patients with a history of RBC antibodies or positive antibody screen prior to enrollment in the study, unless previously cross-matched units are available for transfusion.
- •Patients with ultrasound evidence of right ventricular dilatation at time of CA
- •Patients with known prior objection to receipt of blood products.
- •Patients for whom administration of additional fluid volume is contraindicated (as determined by physician responsible for care)
- •Physician objection based on concern that intervention would interfere with patient care plan
研究组 & 干预措施
Packed Red Blood Cells (1 unit)
500 mL of packed red blood cells
干预措施: Packed Red Blood Cells (1 unit) (Drug)
Saline solution
Treatment of 500 mL of normal saline.
干预措施: Saline (Other)
Packed Red Blood Cells (2 units)
1000 mL of packed red blood cells
干预措施: Packed Red Blood Cells (2 units) (Drug)
结局指标
主要结局
Time (in mins) to administration of Packed Red Blood Cells (PRBC)
时间窗: During Cardiopulmonary Resuscitation (CPR) (up to 20 minutes)
Change in frequency of right ventricular (RV) dilatation
时间窗: Baseline, up to 20 minutes post administration of PRBC
Proportion of patients with unfavorable neurological outcomes
时间窗: Up to 30 days post-Cardiac Arrest (CA)
The Cerebral Performance Category (CPC) score is a five-point scale used to assess neurological outcome after cardiac arrest and other events. Scores range from 1 to 5, a score of 1 or 2 is considered a favorable outcome, and scores of 3, 4, or 5 are considered an unfavorable outcome (severe neurological disability, persistent vegetative state or death).
Frequency of antibody-mediated transfusion reactions
时间窗: 6-72 hours after Return of Spontaneous Circulation (ROSC)
Outcome measure will be evaluated for the occurrence of intravascular and extravascular hemolytic reactions by measuring fibrinogen, D-dimer, platelet count, peripheral blood smear, and serum haptoglobin.
Frequency of non-immune reactions
时间窗: 6-72 hours after ROSC
Non-immune reactions include Transfusion Associated Circulatory Overload (TACO) and Transfusion-Related Acute Lung Injury (TRALI) as determined by the Data Safety Monitoring Committee (DSMC).
All-cause mortality
时间窗: Up to 30 days after the last day of study participation
Mortality due to all causes
次要结局
- Rate of survival(At time of hospital discharge (approximately 12 days))
- Rate of survival(30 days post-CA)
- CPC score(At time of hospital discharge (approximately 12 days))
- CPC score(30 days post-CA)
- Relative change in peak rSO2(2 minutes prior to administration, 5 minutes post administration of PRBC)
- Relative change in mean rSO2(2 minutes prior to administration, 5 minutes post administration of PRBC)
- Rate of survival(90 days post-CA)
- Relative change in peak end tidal carbon dioxide (ETCO2)(2 minutes prior to administration, 5 minutes post administration of PRBC)
- CPC score(90 days post-CA)
- Absolute change in peak regional oxygen saturation (rSO2)(2 minutes prior to administration, 5 minutes post administration of PRBC)
- Absolute change in mean rSO2(2 minutes prior to administration, 5 minutes post administration of PRBC)
- Relative change in mean ETCO2(2 minutes prior to administration, 5 minutes post administration of PRBC)
- Proportion of patients with release of pro-inflammatory cytokines(6-72 hours after ROSC)
- Proportion of patients with release markers of brain injury(6-72 hours after ROSC)
- Rate of ROSC(During CPR (up to 20 minutes))