Postpartum Anemia NosSMaRTBloodNCT03419780
SMaRT Blood: Single-unit Versus Multiple-unit Packed Red Blood Cell Transfusion in Non-acute Postpartum Anemia
A study testing Blood Transfusion in people with Postpartum Anemia Nos, run by University of Pennsylvania at 1 site in United States.
Trial summary
There is a paucity of data on management of non-acute postpartum anemia. Although blood transfusions were historically initiated with 2 units, the most recent recommendation from the American Association of Blood Banks is to begin with 1 unit. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Anemia Nos
- What is being tested?
- Blood Transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 18
- Willing and stable to give consent
- > 6 hours postpartum from any mode of delivery
- Determined by their physician to require blood transfusion either by:
- Hb <7g/dL OR
- >7g/dL with any sign or symptom of anemia such as fatigue, dizziness, tachycardia, or hypotension
- Agreed to accept blood transfusion
- No contraindications to blood transfusion
Who cannot join
- hemoglobinopathies
- patients with an ejection fraction <35%
- Hb <5 g/dL
- HR > 130 bpm, BP < 80/40
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Can a Single-unit Blood Transfusion Protocol in Obstetrics Reduce Total Number of Units Transfused? A Randomized, Controlled Trial
There is a paucity of data on management of non-acute postpartum anemia. Although blood transfusions were historically initiated with 2 units, the most recent recommendation from the American Association of Blood Banks is to begin with 1 unit. As no randomized controlled trials have been performed in obstetrics, the investigators propose a randomized, controlled trial in non-acute postpartum anemia comparing single- versus multiple-unit transfusion by total numbers of units transfused and maternal morbidity.
Read the detailed description
Postpartum hemorrhage (PPH), which accounts for 30% of all direct maternal deaths, is the single most important cause of maternal morbidity and mortality across the globe and is a focus of attention of national organizations such as the Council for Patient Safety in Women's Health in recent years. Yet, there remains a paucity of data on the appropriate management of non-acute postpartum anemia.
It is common practice in obstetrics to offer a transfusion of packed red blood cells (pRBCs) to women with a hemoglobin (Hb) value less than 7 g/dL (hematocrit less than 20%) and to symptomatic women with even higher hemoglobin levels. Although transfusions were historically initiated with 2 units of pRBCs, the most recent recommendation from the American Association of Blood Banks (AABB) for a stable patient is to begin with 1 unit and reassess. However, while surgical data has successfully demonstrated that liberal blood transfusion increases morbidity and mortality in comparison to restricted transfusion, no randomized controlled trials have been performed in obstetrics to demonstrate superiority of a single-unit transfusion protocol.
The investigators propose a randomized, controlled trial in non-acute postpartum anemia comparing single-unit versus multiple-unit transfusion by total numbers of units transfused and maternal morbidity at the University of Pennsylvania with the hypothesis that single-unit transfusions can reduce the number of units transfused without increasing maternal morbidity.
- Conditions
- Postpartum Anemia Nos
- Being tested
- Blood Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TransfusionBiological
Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
| Study group | Role | What they receive |
|---|---|---|
| Single-Unit Blood Transfusion Protocol | Active comparator | In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment. Receives: Biological: Blood Transfusion |
| Multiple-Unit Blood Transfusion Protocol | Active comparator | In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment. Receives: Biological: Blood Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Units Transfused
To determine if there is a difference between single-unit and multiple-unit transfusion protocols in total number of units transfused
Measured: From randomization until discharge from admission for delivery, an average of 2-3 days
Secondary outcomes (6)
Length of Stay
To determine if there is a difference between single-unit and multiple-unit transfusion protocols in length of stay in days
Measured: From randomization until discharge from admission for delivery, an average of 2-3 days
Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum
To determine if there is a difference between single-unit and multiple-unit transfusion protocols in exclusive breastfeeding rates at 4-9 weeks postpartum.
Measured: At 4-9 weeks after randomization
Rate of Depression
- To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Edinburgh Postnatal Depression Scale score at 4-9 weeks postpartum. EPDS scores range from 0-30, with higher scores (particularly above 10) are indicative of depression.
Measured: 4-9 weeks after randomization
Rate of Fatigue
- To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Multidimensional Fatigue Inventory scores at 4-9 weeks postpartum. This score ranges from 0-140 with higher scores indicating worse fatigue.
Measured: 4-9 weeks after randomization
Maternal Attachment Inventory Scores
- To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Maternal Attachment Inventory scores at 4-9 weeks postpartum. The possible range of scores is 26-104. Higher scores indicate higher maternal attachment to the infant.
Measured: 4-9 weeks after randomization
Infection Rate
Development of any deep or superficial infection
Measured: From randomization until 4-9 week postpartum visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Mar 2018
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum Anemia NosStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sindhu K Srinivas, MD MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419780
- Sponsor's protocol ID
- 829141
- Acronym
- SMaRTBlood
- Status last verified
- Nov 2020
- First submitted
- 17 Jan 2018
- Last updated
- 4 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
PubMed 34932836Hamm RF, Perelman S, Wang EY, Levine LD, Srinivas SK. Single-unit vs multiple-unit transfusion in hemodynamically stable postpartum anemia: a pragmatic randomized controlled trial. Am J Obstet Gynecol. 2021 Jan;224(1):84.e1-84.e7. doi: 10.1016/j.ajog.2020.07.007. Epub 2020 Jul 9.
PubMed 32652065
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Single-unit Blood Transfusion Protocol in Obstetrics Reduce Total Number of Units Transfused? A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03419780
- Acronym / sponsor ID
- SMaRTBlood / 829141
- Conditions
- Postpartum Anemia Nos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 4 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a paucity of data on management of non-acute postpartum anemia. Although blood transfusions were historically initiated with 2 units, the most recent recommendation from the American Association of Blood Banks is to begin with 1 unit. As no randomized controlled trials have been performed in obstetrics, the investigators propose a randomized, controlled trial in non-acute postpartum anemia comparing single- versus multiple-unit transfusion by total numbers of units transfused and maternal morbidity.
Detailed description
Postpartum hemorrhage (PPH), which accounts for 30% of all direct maternal deaths, is the single most important cause of maternal morbidity and mortality across the globe and is a focus of attention of national organizations such as the Council for Patient Safety in Women's Health in recent years. Yet, there remains a paucity of data on the appropriate management of non-acute postpartum anemia.
It is common practice in obstetrics to offer a transfusion of packed red blood cells (pRBCs) to women with a hemoglobin (Hb) value less than 7 g/dL (hematocrit less than 20%) and to symptomatic women with even higher hemoglobin levels. Although transfusions were historically initiated with 2 units of pRBCs, the most recent recommendation from the American Association of Blood Banks (AABB) for a stable patient is to begin with 1 unit and reassess. However, while surgical data has successfully demonstrated that liberal blood transfusion increases morbidity and mortality in comparison to restricted transfusion, no randomized controlled trials have been performed in obstetrics to demonstrate superiority of a single-unit transfusion protocol.
The investigators propose a randomized, controlled trial in non-acute postpartum anemia comparing single-unit versus multiple-unit transfusion by total numbers of units transfused and maternal morbidity at the University of Pennsylvania with the hypothesis that single-unit transfusions can reduce the number of units transfused without increasing maternal morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Unit Blood Transfusion Protocol | Active comparator | Biological: Blood TransfusionIn this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment. |
| Multiple-Unit Blood Transfusion Protocol | Active comparator | Biological: Blood TransfusionIn this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women over 18
- Willing and stable to give consent
- > 6 hours postpartum from any mode of delivery
- Determined by their physician to require blood transfusion either by:
- Agreed to accept blood transfusion
Key exclusion criteria (4 listed)
- hemoglobinopathies
- patients with an ejection fraction <35%
- Hb <5 g/dL
- HR > 130 bpm, BP < 80/40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood TransfusionPatients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion. | Biological | Multiple-Unit Blood Transfusion Protocol, Single-Unit Blood Transfusion Protocol |
Primary outcome
Total Number of Units Transfused
Time frame: From randomization until discharge from admission for delivery, an average of 2-3 days
To determine if there is a difference between single-unit and multiple-unit transfusion protocols in total number of units transfused
6 secondary outcomes
Length of Stay
Time frame: From randomization until discharge from admission for delivery, an average of 2-3 days
Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum
Time frame: At 4-9 weeks after randomization
Rate of Depression
Time frame: 4-9 weeks after randomization
Rate of Fatigue
Time frame: 4-9 weeks after randomization
Maternal Attachment Inventory Scores
Time frame: 4-9 weeks after randomization
Infection Rate
Time frame: From randomization until 4-9 week postpartum visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34932836Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
- Derived from this study: PubMed 32652065Hamm RF, Perelman S, Wang EY, Levine LD, Srinivas SK. Single-unit vs multiple-unit transfusion in hemodynamically stable postpartum anemia: a pragmatic randomized controlled trial. Am J Obstet Gynecol. 2021 Jan;224(1):84.e1-84.e7. doi: 10.1016/j.ajog.2020.07.007. Epub 2020 Jul 9.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sindhu K Srinivas, MD MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Transfusion in people with Postpartum Anemia Nos, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Units Transfused (time frame: From randomization until discharge from admission for delivery, an average of 2-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03419780, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020; AzTrials last refreshed its copy on 26 Oct 2026.