Protocol - Transfusion Reactions

Description

This protocol includes 4 items from the Silent Cerebral Infarct Transfusion (SIT) Trial that capture transfusion reactions during treatment or shortly after completion of treatment, associated complications, and outcomes.

Specific Instructions

The Sickle Cell Disease Pregnancy Working Group (WG) acknowledges that the forms were developed for children ages 5–14 years but recommends that these forms can also be used for pregnant people with sickle cell disease. The WG further recommends that investigators also consider these related protocols: Prophylactic Transfusion during Pregnancy and Transfusion Indications. Although there is some duplication among these protocols, they contain varying degrees of detail.

Availability

Available

Download PDF

Protocol

S32r0 Transfusion Reaction Form

Ad Hoc Event ID _________________________________

Visit Date (yyyy/mm/dd): _________________________________

Correction:

[ ] Yes

[ ] No

Use this form to report transfusion reactions either during treatment or within 15 minutes after completion of treatment.

1. Date of transfusion (yyyy/mm/dd): _______________________________

2. Type of transfusion:

[ ] Simple

[ ] Modified exchange

[ ] Erythrocytapheresis

3. Type of reaction:

[ ] Febrile non-hemolytic

[ ] Allergic or anaphylactoid

[ ] Hemolytic transfusion reaction (HTR)

4. Associated complications:

[ ] Hypertension and circulatory overload

[ ] Vaso-occlusive

[ ] Transient ischemic attack

A descriptive, narrative report of all transfusion reactions is recommended by the {study name}. Please use the field below to upload your narrative for this transfusion reaction. The narrative must include the Patient ID number and date of the transfusion reaction, followed by a complete description of the occurrence, procedures followed, and outcome.

Staff I.D. #: ______________________________

Personnel and Training Required

Personnel who are trained in performing medical records review.

Equipment Needs

None

Requirements

Requirement Category	Required
Major equipment	No
Specialized training	No
Specialized requirements for biospecimen collection	No
Average time of greater than 15 minutes in an unaffected individual	No

Mode of Administration

Medical record abstraction

Lifestage

Child, Adolescent, Adult, Pregnancy

Participants

Children and adults with sickle cell disease.

Selection Rationale

These items from the Silent Cerebral Infarct Transfusion (SIT) Trial are easy to administer, are brief, and capture the necessary details relevant to transfusion reactions. This protocol came from the SIT Trial, a randomized controlled trial in a pediatric sickle cell disease population.

Language

English

Standards

Standard	Name	ID	Source

Derived Variables

None

Process and Review

Not Applicable

Protocol Name from Source

Silent Cerebral Infarct Transfusion (SIT) Trial, S32r0 Transfusion Reaction Form

Source

DeBaun, M. R., Gordon, M., McKinstry, R. C., Noetzel, M. J., White, D. A., Sarnaik, S. A., Meier, E. R., Howard, T. H., Majumdar, S., Inusa, B. P., Telfer, P. T., Kirby-Allen, M., McCavit, T. L., Kamdem, A., Airewele, G., Woods, G. M., Berman, B., Panepinto, J. A., Fuh, B. R., Kwiatkowski, J. L., ? Casella, J. F. (2014). Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia. The New England journal of medicine, 371(8), 699?710. https://doi.org/10.1056/NEJMoa1401731

Silent Cerebral Infarct Transfusion (SIT) Trial, S32r0 Transfusion Reaction Form, Items 1?4.

General References

DeBaun, M. R., Sarnaik, S. A., Rodeghier, M. J., Minniti, C. P., Howard, T. H., Iyer, R. V., Inusa, B., Telfer, P. T., Kirby-Allen, M., Quinn, C. T., Bernaudin, F., Airewele, G., Woods, G. M., Panepinto, J. A., Fuh, B., Kwiatkowski, J. K., King, A. A., Rhodes, M. M., Thompson, A. A., Heiny, M. E., Redding-Lallinger, R. C., Kirkham, F. J., Sabio, H., Gonzalez, C. E., Saccente, S. L., Kalinyak, K. A., Strouse, J. J., Fixler, J. M., Gordon, M. O., Miller, J. P., Noetzel, M. J., Ichord, R. N., & Casella, J. F. (2012). Associated risk factors for silent cerebral infarcts in sickle cell anemia: Low baseline hemoglobin, sex, and relative high systolic blood pressure. Blood, 119(16), 3684?3690. doi:10.1182/blood-2011-05-349621

Pan, H., Ives, C., Mandal, M., Qin, Y., Hendershot, T., Popovic, J., Brambilla, D., Stratford, J., Treadwell, M., Wu, X., & Kroner, B. (2022). CureSCi Metadata Catalog?Making sickle cell studies findable. PLOS ONE, 17(12), e0256248. https://doi.org/10.1371/journal.pone.0256248

Protocol ID

890501

Variables

Export Variables

Variable Name	Variable ID	Variable Description	dbGaP Mapping
PX890501_Transfusion_Reactions_Complications
	PX890501070000	Associated complications:	N/A
PX890501_Transfusion_Reactions_Event_ID
	PX890501010000	Ad Hoc Event ID	N/A
PX890501_Transfusion_Reactions_Is_Correction
	PX890501030000	Correction	N/A
PX890501_Transfusion_Reactions_Transfusion_Date
	PX890501040000	Date of transfusion (yyyy/mm/dd): more _______________________________ show less	N/A
PX890501_Transfusion_Reactions_Transfusion_Reaction
	PX890501060000	Type of reaction:	N/A
PX890501_Transfusion_Reactions_Transfusion_Type
	PX890501050000	Type of transfusion:	N/A
PX890501_Transfusion_Reactions_Visit_Date
	PX890501020000	Visit Date (yyyy/mm/dd):	N/A

SCD Pregnancy

Measure Name

Transfusion Reactions

Release Date

August 5, 2024

Definition

Blood transfusions are an important therapeutic intervention in both children and adults with sickle cell disease. However, transfusion reactions and associated complications are not uncommon adverse effects of transfusion therapy.

Purpose

Red blood cell transfusions in pregnant women with sickle cell disease may reduce maternal complications and mortality, as well as pre-term birth and perinatal mortality. Transfusions, however, are not free of adverse effects, and monitoring and detailed documentation of such events is critical for the management of these recipients and for the prevention of future transfusion-related complications. This measure assesses a participant’s history of transfusion reactions.

Keywords

sickle cell disease, SCD, transfusion, blood transfusion, red cell transfusion, exchange transfusion, simple transfusion, pregnancy, Silent Cerebral Infarct Transfusion (SIT) Trial, transfusion reaction

Measure Protocols

Protocol ID	Protocol Name
890501	Transfusion Reactions

Publications

There are no publications listed for this protocol.