Optimization of Biotinylation Protocol for Studies of Red Blood Cell Survival and Function After Transfusion

Summary

The goal of this clinical trial is to compare two methods of labeling red blood cells with biotin. The main question to answer is whether red blood cells labeled 48 hours before transfusion survive as long as red blood cells labeled 6 hours before transfusion. Secondary questions are to measure the quality of the red blood cells and whether or not the biotin-labeled red blood cells induce antibodies in transfusion recipients. This study participant will have six study visits: 1. Screening visit, collect 35 ml blood, about 3 tablespoons 2. Donate 500 ml blood 3. Receive 20 ml of biotin labeled blood transfusion, collect 40 ml blood, about 3 tablespoons 4. Return 1 day after transfusion for blood draw (25 ml, about 2 tablespoons) 5. Return 30 days after transfusion for blood draw (25 ml, about 2 tablespoons) 6. Return 90 days after transfusion for blood draw (25 ml, about 2 tablespoons)

Timeline

Start

2024-03-07

Primary completion

2024-11-04

Completion

2024-11-04

Publications

• Background Donnenberg AD, Kim-Shapiro DB, Kanias T, Moore LR, Kiss JE, Lee JS, Xiong Z, Wang L, Triulzi DJ, Gladwin MT. Optimizing interpretation of survival studies of fresh and aged transfused biotin-labeled RBCs. Transfusion. 2023 Jan;63(1):35-46. doi: 10.1111/trf.17192. Epub 2022 Dec 9.
• Background Mock DM, Stowell SR, Franco RS, Kyosseva SV, Nalbant D, Schmidt RL, Cress GA, Strauss RG, Cancelas JA, von Goetz M, North AK, Widness JA. Antibodies against biotin-labeled red blood cells can shorten posttransfusion survival. Transfusion. 2022 Apr;62(4):770-782. doi: 10.1111/trf.16849. Epub 2022 Mar 11.

Drugs

Indications

No indication recorded.