Protocol - Transfusion Indications

Description

This protocol includes seven items from the Silent Cerebral Infarct Transfusion (SIT) Trial that capture the reason for transfusion, pre-transfusion laboratory results, pre-medications administered, the type of transfusion, and the volume transfused.

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 Reactions. Although there is some duplication among these protocols, they contain varying degrees of detail.

The WG removed an annotation in question 2d indicating that an adverse events form should be completed if there are neurological symptoms.

Availability

Available

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Protocol

S31r4 Transfusion Form

Patients Identification Number ______________________________

Visit Date (yyyy/mm/dd): ______________________________

Correction:

[ ] Yes

[ ] No

1. Date of transfusion (yyyy/mm/dd) _____________________________

2. Reason for transfusion

[ ] Scheduled

[ ] Non-Scheduled

2. If transfusion is non-scheduled, answer Items 2A through 2F.

2A. Acute chest syndrome

[ ] Yes

[ ] No

2B. Painful episode

[ ] Yes

[ ] No

2C. Multi-organ failure

[ ] Yes

[ ] No

2D. Neurological symptoms

[ ] Yes

[ ] No

2E. Surgery

[ ] Yes

[ ] No

2F. Other

[ ] Yes

[ ] No

2F-1. Please indicate other: _______________________________

3. Pre-transfusion laboratory results

3A. Hemoglobin S

[ ] Done

[ ] Not Done

3A-1. Date obtained (yyyy/mm/dd) _______________________________

3A-2. Results (xxx.x %) _______________________________

3B. Ferritin

[ ] Done

[ ] Not Done

3B-1. Date obtained (yyyy/mm/dd) _______________________________

3B-2. Results (xxxx.x ng/ml) ________________________________

3C. Hemoglobin level

[ ] Done

[ ] Not Done

3C-1. Date obtained (yyyy/mm/dd) _______________________________

3C-2. Results (xx.x g/dl) ________________________________

4. Pre-medications administered:

4A. Tylenol

[ ] Yes

[ ] No

4B. Benadryl

[ ] Yes

[ ] No

4C. Claritin

[ ] Yes

[ ] No

4D. Other

[ ] Yes

[ ] No

4E. None given

[ ] Yes

[ ] No

5. Transfusion:

5. Simple transfusion

[ ] Done

[ ] Not Done

5A. Amount transfused (xxxx cc) _______________________________

6. Modified manual exchange

[ ] Done

[ ] Not Done

6A. Amount removed (xxxx cc) _______________________________

6B. Amount transfused (xxxx cc) _______________________________

7. Pheresis

[ ] Done

[ ] Not Done

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, brief, and capture the necessary details relevant to red cell transfusion. 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, S31r4 Transfusion 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 S31r4 Transfusion Form, Items 1-7.

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

890401

Variables

Export Variables

Variable Name	Variable ID	Variable Description	dbGaP Mapping
PX890401_Transfusion_Indications_Acs
	PX890401050000	Acute chest syndrome	N/A
PX890401_Transfusion_Indications_Amount_Simple
	PX890401190000	Amount transfused more _______________________________ show less	N/A
PX890401_Transfusion_Indications_Correction
	PX890401020000	Correction:	N/A
PX890401_Transfusion_Indications_Date
	PX890401010000	Visit Date: more ______________________________ show less	N/A
PX890401_Transfusion_Indications_Date_Ferritin
	PX890401080000	Date obtained more _______________________________ show less	N/A
PX890401_Transfusion_Indications_Date_Hemoglobin
	PX890401110000	Date obtained more _______________________________ show less	N/A
PX890401_Transfusion_Indications_Date_Hs
	PX890401050800	Date obtained more _______________________________ show less	N/A
PX890401_Transfusion_Indications_Date_Transfusion
	PX890401030000	Date of transfusion more _____________________________ show less	N/A
PX890401_Transfusion_Indications_Ferritin
	PX890401070000	Ferritin	N/A
PX890401_Transfusion_Indications_Hemoglobin
	PX890401100000	Hemoglobin level	N/A
PX890401_Transfusion_Indications_Hemoglobin_S
	PX890401050700	Hemoglobin S	N/A
PX890401_Transfusion_Indications_Mme_Simple
	PX890401200000	Modified manual exchange	N/A
PX890401_Transfusion_Indications_Mof
	PX890401050200	Multi-organ failure	N/A
PX890401_Transfusion_Indications_Neuro_Symptom
	PX890401050300	Neurological symptoms	N/A
PX890401_Transfusion_Indications_Other
	PX890401050500	Other	N/A
PX890401_Transfusion_Indications_Other_Desc
	PX890401050600	Please indicate other: more _______________________________ show less	N/A
PX890401_Transfusion_Indications_Pain
	PX890401050100	Painful episode	N/A
PX890401_Transfusion_Indications_Pheresis
	PX890401230000	Pheresis	N/A
PX890401_Transfusion_Indications_Pre_Medication_Benadryl
	PX890401140000	Pre-medications administered: Benadryl	N/A
PX890401_Transfusion_Indications_Pre_Medication_Claritin
	PX890401150000	Pre-medications administered: Claritin	N/A
PX890401_Transfusion_Indications_Pre_Medication_None
	PX890401170000	Pre-medications administered: None given	N/A
PX890401_Transfusion_Indications_Pre_Medication_Other
	PX890401160000	Pre-medications administered: Other	N/A
PX890401_Transfusion_Indications_Pre_Medication_Tylenol
	PX890401130000	Pre-medications administered: Tylenol	N/A
PX890401_Transfusion_Indications_Reason
	PX890401040000	Reason for transfusion	N/A
PX890401_Transfusion_Indications_Removed_Simple
	PX890401210000	Amount removed more _______________________________ show less	N/A
PX890401_Transfusion_Indications_Results_Ferritin
	PX890401090000	Results more ________________________________ show less	N/A
PX890401_Transfusion_Indications_Results_Hemoglobin
	PX890401120000	Results more ________________________________ show less	N/A
PX890401_Transfusion_Indications_Results_Hs
	PX890401060000	Results more _______________________________ show less	N/A
PX890401_Transfusion_Indications_Simple
	PX890401180000	Simple transfusion	N/A
PX890401_Transfusion_Indications_Surgery
	PX890401050400	Surgery	N/A
PX890401_Transfusion_Indications_Transfused_Simple
	PX890401220000	Amount transfused more _______________________________ show less	N/A

SCD Pregnancy

Measure Name

Transfusion Indications

Release Date

August 5, 2024

Definition

Blood transfusion is an important therapeutic intervention in both children and adults with sickle cell disease.

Purpose

Transfusion therapy is used to treat and prevent sickle cell disease (SCD) complications. Transfusion in pregnant people with SCD, in the right context, may reduce maternal mortality, vaso-occlusive pain events, and pulmonary complications, as well as pre-term birth and perinatal mortality, but must be used judiciously in consultation with hematology to balance its risks.

Keywords

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

Measure Protocols

Protocol ID	Protocol Name
890401	Transfusion Indications

Publications

There are no publications listed for this protocol.

Protocol - Transfusion Indications

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Description

Specific Instructions

Availability

Protocol

Personnel and Training Required

Equipment Needs

Requirements

Mode of Administration

Lifestage

Participants

Selection Rationale

Language

Standards

Derived Variables

Process and Review

Protocol Name from Source

Source

General References

Protocol ID

Variables

Measure Name

Release Date

Definition

Purpose

Keywords

Measure Protocols

Publications