Protocol - Prophylactic Transfusion during Pregnancy
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
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 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
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
Standard | Name | ID | Source |
---|
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 VariablesVariable Name | Variable ID | Variable Description | dbGaP 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 | N/A | ||
PX890301_Prophylactic_Transfusion_During_Pregnancy_Adverse_Event_DHTR | ||||
PX890301130300 | Adverse Events/Transfusion Reactions Delayed more | N/A | ||
PX890301_Prophylactic_Transfusion_During_Pregnancy_Adverse_Event_Yes | ||||
PX890301130100 | Adverse Events/Transfusion Reactions Yes, more | 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 | 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 |
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.