Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair
キーワード
概要
説明
Patients between the ages of 2 to 6 months of age and undergo a sagittal synostosis repair will split into two groups to participate in a prospective pilot study. The purpose of this study is to examine the extracellular potassium levels in patients who receive irradiated blood versus non-irradiated blood. Enrollment will occur over a 24 month period or until 20 patients are enrolled. The patient names, medical record numbers and any other identifiers will be kept strictly confidential.
Patients will receive irradiated or non-irradiated blood based on their age. Patients under 4 months of age will receive irradiated blood products, as per hospital protocol, while patients over 4 months of age will receive non-irradiated blood products.
Patients will receive standard surgical practice for their craniosynostosis repair and will receive the blood transfusion at the discretion of the anesthesiologist and surgeon. All the blood that is transfused will be analyzed prior to transfusion. The patient's extracellular potassium levels will be recorded pre-transfusion, at 30 minute intervals during the transfusion, and post-transfusion. The collected data will be compared to test for correlation between extracellular potassium levels, the type of blood transfused, and the amount of calcium that is administered.
There is minimal risk of harm associated with the study. All surgical procedures run their typical risk of infection, bleeding or any other complication that could occur during or after the operation. The blood transfusions may also increase patient's risk of graft versus host disease, hyperkalemia, or cardiac anomalies. These cases will be documented and responded to according to anesthesiologist and surgeon's preference.
Materials and information necessary to carry out this experiment include: patient age, sex, weight, type of blood transfused (ABO and non-irradiated/irradiated), vital signs, operating time, amount of blood lost, adverse events, and length of stay.
Patients who decline participation in the study will have no change in their anesthetic or post-operative care.
日付
| 最終確認済み: | 09/30/2018 |
| 最初に提出された: | 06/21/2015 |
| 提出された推定登録数: | 06/23/2015 |
| 最初の投稿: | 06/28/2015 |
| 最終更新が送信されました: | 10/16/2018 |
| 最終更新日: | 10/18/2018 |
| 実際の研究開始日: | 07/31/2015 |
| 一次完了予定日: | 05/10/2017 |
| 研究完了予定日: | 05/10/2017 |
状態または病気
介入/治療
Other: Patients under 4 months Receive Irradiated Blood
Other: Patients Over 4 Months Recieve Non-Irradiated Blood
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Patients under 4 months Receive Irradiated Blood Patients under 4 months of age will receive irradiated blood products, as per hospital protocol. The patient's extracellular potassium levels will be recorded pre-transfusion, at 30 minute intervals during the transfusion, and post-transfusion. The collected data will be compared to test for correlation between extracellular potassium levels, the type of blood transfused, and the amount of calcium that is administered. | Other: Patients under 4 months Receive Irradiated Blood Same as arm description - need to collect extracellular potassium values. |
| Experimental: Patients Over 4 Months Recieve Non-Irradiated Blood Patients over 4 months of age will receive non-irradiated blood products. The patient's extracellular potassium levels will be recorded pre-transfusion, at 30 minute intervals during the transfusion, and post-transfusion. The collected data will be compared to test for correlation between extracellular potassium levels, the type of blood transfused, and the amount of calcium that is administered. | Other: Patients Over 4 Months Recieve Non-Irradiated Blood Same as arm description - need to collect extracellular potassium values. |
適格基準
| 研究の対象となる年齢 | 2 Months に 2 Months |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Must be between 2-6 m/o - Must be undergoing a craniosynostosis repair - Must require a blood transfusion Exclusion Criteria: - n/a |
結果
主な結果の測定
1. Change in extracellular potassium values. [immediately after transfusion and 30 minutes after the end of transfusion]
