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Protocol - Prophylactic Transfusion during Pregnancy

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Description

This protocol is a combination of 13 relevant items from two different sources (Malinowski et al. 2015; Oakley et al. 2020) that captures detailed variables and outcome measures relating to transfusions in pregnant people with sickle cell disease. Information captured includes transfusion indication, type, frequency, and hemoglobin measures.

Specific Instructions

The Sickle Cell Disease Pregnancy Working Group recommends that investigators also consider these related protocols: Transfusion Indications and Transfusion Reactions. Although there is some duplication among these protocols, they contain varying degrees of detail. In addition, investigators might consider adding questions regarding alloimmunization and if alloantibodies were present prior to pregnancy.

Availability

Available

Protocol

Prophylactic Transfusion during Pregnancy

1. Transfusion Schedule

[ ] Obstetrically Indicated

[ ] Hematologically Indicated

[ ] Obstetrically/Hematologically Indicated

[ ] Prophylactic

[ ] None

2. Transfusion Type

[ ] Simple

[ ] Partial-Exchange

[ ] Exchange

3. Transfusion Frequency

[ ] Per Indication

[ ] Weekly

[ ] Monthly

[ ] Other _________

4. Timing of First Transfusion ____ weeks Gestational Age

5. Hb Target ___ g/L

6. HbS Target ___ %

7. Pre-Transfusion HbS _____%

8. Post-Transfusion HbS _____%

9. Pre-Transfusion Hb _____ g/L

10. Post-Transfusion Hb _____ g/L

11. Number of Transfusions _____

12. Number of Units Transfused _____

13. Adverse Events/Transfusion Reactions

[ ] No

[ ] Yes, Number of Reactions _____

[ ] Alloimmunization ______________________________________________________

[ ] Delayed Hemolytic Transfusion Reaction ___________________________________

Personnel and Training Required

Personnel should be trained in medical record abstraction.

Equipment Needs

None

Requirements
Requirement CategoryRequired
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

Adolescent, Adult

Participants

Pregnant people with sickle cell disease

Selection Rationale

These questions from Malinowski et al. (2015) and Oakley et al. (2020) were selected as the best way to capture the details regarding transfusion during pregnancy and hemoglobin levels.

Language

English

Standards
StandardNameIDSource
Derived Variables

NA

Process and Review

[include]

Protocol Name from Source

Malinowski AK, et al. Prophylactic transfusion for pregnant women with sickle cell disease: a systematic review and meta-analysis. Blood. 2015

Oakley LL, et al. Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial. Trials. 2020

Source

Malinowski, A. K., Shehata, N., D?Souza, R., Kuo, K. H., Ward, R., Shah, P. S., & Murphy, K. (2015). Prophylactic transfusion for pregnant women with sickle cell disease: A systematic review and meta-analysis. Blood, 126(21), 2424?2435. https://doi.org/10.1182/blood-2015-06-649319. Items 1?6, 9?10, and 12

Oakley, L. L., Awogbade, M., Brien, S., Briley, A., Chorozoglou, M., Drasar, E., Johns, J., Rhodes, E., Robinson, V., Seed, P., Sharif, J., Singh, C., Telfer, P., Thompson, H., Watt-Coote, I., Howard, J., & Oteng-Ntim, E. (2020). Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): Study protocol for a randomised controlled feasibility trial. Trials, 21(1), 347. doi:10.1186/s13063-020-4212-8. Items 7?8, 11, and 13

General References

Koshy, M., Burd, L., Wallace, D., Moawad, A., & Baron, J. (1988). Prophylactic red-cell transfusions in pregnant patients with sickle cell disease. A randomized cooperative study. The New England journal of medicine, 319(22), 1447?1452. https://doi.org/10.1056/NEJM198812013192204

Okusanya, B. O., & Oladapo, O. T. (2013). Prophylactic versus selective blood transfusion for sickle cell disease in pregnancy. The Cochrane database of systematic reviews, (12), CD010378. https://doi.org/10.1002/14651858.CD010378.pub2

Protocol ID

890301

Variables
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX890301_Prophylactic_Transfusion_During_Pregnancy_Adverse_Event
PX890301130000 Adverse Events/Transfusion Reactions N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Adverse_Event_AI
PX890301130200 Adverse Events/Transfusion Reactions more
Alloimmunization ______________________________________________________ show less
N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Adverse_Event_DHTR
PX890301130300 Adverse Events/Transfusion Reactions Delayed more
Hemolytic Transfusion Reaction ___________________________________ show less
N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Adverse_Event_Yes
PX890301130100 Adverse Events/Transfusion Reactions Yes, more
Number of Reactions _____ show less
N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Freq
PX890301030000 Transfusion Frequency N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Freq_Other
PX890301030100 Transfusion Frequency Other _________ N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Hb
PX890301050000 Hb Target ___ g/L N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Hbs
PX890301060000 HbS Target ___ % N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Number
PX890301110000 Number of Transfusions _____ N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Post_Hb
PX890301100000 Post-Transfusion Hb _____ g/L N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Pre_Hb
PX890301090000 Pre-Transfusion Hb _____ g/L N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Pre_Hbs
PX890301070000 Pre-Transfusion HbS _____% N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Schedule
PX890301010000 Transfusion Schedule N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Timing_First
PX890301040000 Timing of First Transfusion ____ weeks more
Gestational Age show less
N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Type
PX890301020000 Transfusion Type N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy_Units
PX890301120000 Number of Units Transfused _____ N/A
PX890301_Prophylactic_Transfusion_During_Pregnancy__Post_Hbs
PX890301080000 Post-Transfusion HbS _____% N/A
SCD Pregnancy
Measure Name

Prophylactic Transfusion During Pregnancy

Release Date

August 5, 2024

Definition

Prophylactic red blood cell transfusions can reduce complications in pregnant people with sickle cell disease by correcting severe anemia and the extent of vaso-occlusion in both the maternal and placental circulations. 

Purpose

Prophylactic transfusions in pregnant people with sickle cell disease (SCD) may reduce maternal mortality, vaso-occlusive pain events, pulmonary complications, and pre-term birth and perinatal mortality. Preventive transfusions (in the absence of complications) starting in the early weeks of pregnancy or on-demand transfusions (strictly for medical/obstetric indications) are both used to manage these cases. Further research is needed to determine whether the benefits of prophylactic transfusions outweigh the risks. This case report form captures data for the study of transfusion therapy in pregnant people with SCD.

Keywords

sickle cell disease, SCD, transfusion, pregnancy, prophylactic transfusion

Measure Protocols
Protocol ID Protocol Name
890301 Prophylactic Transfusion during Pregnancy
Publications

There are no publications listed for this protocol.