How U.S. Blood Banks Handle Therapeutic Phlebotomy for Men on Testosterone Replacement Therapy (TRT)

[Nelson Vergel]

How U.S. Blood Banks Handle Therapeutic Phlebotomy for Men on Testosterone Replacement Therapy (TRT)
Blood centers have had to adapt their policies because the polycythemia/erythrocytosis that often accompanies TRT creates both medical need (frequent blood removal) and regulatory challenges (how to label and use that blood). Key “special considerations” now in place fall into four broad areas:

Area	Typical Blood-bank Practice	Why It Matters
FDA variance & product labeling	Many centers operate under an FDA-approved alternative procedure (21 CFR 640.120) that lets them draw and transfuse red-cell units from TRT donors without labeling them with the donor’s medical condition. However, plasma and platelet components are discarded or barred from transfusion until more safety data emerge[1].	Prevents over-loss of usable red cells while protecting recipients from unknown hormone exposure.
Component restrictions	- Collect RBCs only; plasma/platelets discarded[1]. - Units labeled internally as “TRT crossover” or similar to route them correctly[2].	Limits hormone exposure risk to patients and simplifies inventory handling.
Donation frequency flexibility	Centers with an FDA variance can accept TRT donors more often than the standard 56 days, sometimes as often as every 14 days, provided hematocrit targets and physician orders are met (e.g., Carter BloodCare program)[3].	Meets the therapeutic need of TRT-induced polycythemia without charging the donor or turning them away.
Fee structures	Most nonprofit centers provide the service at no cost if the donor meets allogeneic criteria (e.g., Gulf Coast Regional, Carter BloodCare)[4][5]. If the donor fails standard eligibility or needs draws more frequently than FDA rules allow, a clinical-services fee is charged (e.g., Vitalant)[6].	Balances patient access with the added staffing/supply costs of high-frequency draws.
Physician-order requirements	- If draws occur at ≥ 8-week intervals and the donor clears routine eligibility, no prescription is required at some centers (Gulf Coast form language)[7]. - More frequent or non-qualified draws need a signed therapeutic-phlebotomy order renewed annually[2].	Ensures medical oversight and documents the therapeutic indication.
Hematocrit/hemoglobin thresholds	Common stop-rules: do not bleed if Hct < 54% (therapeutic indication gone) or if it falls below standard donor minima (39% men)[4][8].	Protects donor safety and confirms ongoing medical necessity.
Donor-history questions	TRT use is explicitly captured during screening so units can be routed to the RBC-only pathway and platelet/plasma are quarantined[1].	Maintains compliance with the FDA variance.

Illustrative Programs
· Gulf Coast Regional Blood Center (Houston, TX)
– TRT donors may give more frequently than 8 weeks; no fees; must keep therapeutic order on file[4].
· Carter BloodCare (Texas)
– FDA variance allows draws every 14 days; no-cost phlebotomy for TRT donors who meet allogeneic criteria; dedicated “Testosterone Therapy” info page[5][3].
· Vitalant (national)
– Offers TP for TRT; standard 56-day interval if donating for transfusion; higher-frequency draws available by appointment with a physician order and subject to a special handling fee[6][9].
· We Are Blood (Austin, TX)
– “TTCX” program: TRT donors qualifying for community use can donate RBCs; plasma discarded; physician order only if <56-day interval or other disqualifiers[2].
Regulatory Background Driving These Policies
1. FDA alternative procedure (640.120) approvals grant centers permission to use red-cell components from TRT therapeutic donors and to waive disease-labeling rules, but only RBCs can be distributed; other components withheld due to uncertain testosterone content[1].
2. 2018 FDA decision formally allowed RBCs from TRT therapeutic phlebotomies for transfusion, stimulating many blood banks to create “TRT crossover” programs[10].
Practical Take-aways for TRT Patients
· Ask your local center whether it has a TRT program; many national networks (Vitalant, Versiti, Carter, We Are Blood, Gulf Coast, LifeShare, Kentucky Blood Center) now accommodate therapeutic needs.
· Bring or file a physician order if you need draws more often than every 56 days or if previous labs show Hct > 54%.
· Expect RBC-only donation; plasma/platelets will not be used.
· No fees are typical when you meet standard donor criteria and stay within FDA-allowed frequency; otherwise modest service fees may apply.
These tailored protocols let men on TRT control hematocrit safely while bolstering the nation’s red-cell inventory.


1. https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/resources/ask-the-fda-and-clia-transcripts/2014-ask-the-fda-and-clia-transcript
2. https://weareblood.org/therapeutic-phlebotomy/
3. https://www.carterbloodcare.org/education-center/types-of-donations/therapeutic-phlebotomy/
4. https://www.giveblood.org/donate/types-of-donations/therapeutic-phlebotomy-form/
5. https://www.carterbloodcare.org/education-center/types-of-donations/testosterone-therapy/
6. https://www.vitalant.org/hospitals/special-collections
7. https://www.giveblood.org/media/1313/request-for-theraputic-phlebotomy.pdf
8. https://www.aetna.com/cpb/medical/data/600_699/0652.html
9. https://www.vitalant.org/eligibility/hh-tt

10. https://pmc.ncbi.nlm.nih.gov/articles/PMC7902463/

 

[Nelson Vergel]

Thread 'Where to Get Therapeutic Phlebotomies to Lower High Hematocrit in the U.S.'

Dec 27, 2023

Understanding Therapeutic Phlebotomies to Lower High Hematocrit​

What is High Hematocrit?​

High hematocrit occurs when your body produces an increased number of blood cells, leading to thicker, more "viscous" blood. This condition strains the heart's ability to pump blood effectively, increasing the risk of blood pressure issues, strokes, and heart attacks.

Testosterone Therapy and Hematocrit Levels​

Testosterone replacement therapy, often used to boost muscle mass and sex drive, can increase blood cell production. This is beneficial for those with...

• Nelson Vergel
• Replies: 3
• Forum: Blood Test Discussion

 

[Nelson Vergel]

How Current U.S. Blood-Bank Policies Shape Eligibility for Testosterone-Replacement-Therapy (TRT) Patients
Blood banks now routinely distinguish between two very different donation scenarios for men on TRT, and each comes with its own set of eligibility hurdles and conveniences. Understanding the split is key to knowing whether you will be welcomed as a regular volunteer donor or routed into a therapeutic-phlebotomy program.

Question	Volunteer (Allogeneic) Donation Path	Therapeutic-Phlebotomy Path
Basic rule	You’re treated like any other donor if you meet all standard criteria (age, weight, vitals, infectious-disease history). TRT alone is not a deferral[1][2].	You donate under a physician order to lower hematocrit caused by TRT-induced erythrocytosis; the draw is primarily for your health, secondarily for inventory[3][4].
Component use	FDA variances require blood centers to discard plasma and platelets from TRT donors; only red-cell units are released for transfusion[5][6].	Same restriction. Your RBCs may be labeled “TTCX” or “TRT crossover” and transfused; other components are tossed[7][5].
Donation frequency	Default federal limit remains every 56 days. A few centers with approved alternative procedures invite TRT donors back every 14–28 days if their hematocrit stays high and they still clear screening[1][3][8].	Frequency is dictated by the physician’s prescription—often every 2–8 weeks. Centers will not exceed what the order specifies and may stop once Hct < 54% or Hgb < 13 g/dL[4][9].
Need for a doctor’s order	Not required unless you want to give sooner than 56 days or fail another standard requirement[7].	Always required; renewed yearly. Order must list diagnosis, target Hgb/Hct, and maximum draw volume[4][10].
Fees	Usually no charge; you earn the same rewards points as other donors[3][7].	Often free for TRT diagnosis, but some multistate systems (e.g., Vitalant) bill a clinical-services fee when the blood cannot be used or draws exceed FDA frequency limits[11][12].
What can disqualify you	Any routine donor deferral (recent travel, malaria risk, certain medications) still applies[13][14]. Failing the Hgb minimum (< 13.0 g/dL) also defers you.	Beyond standard vitals, centers may refuse if you have co-morbidities (e.g., heart disease requiring supervision) or infectious markers noted on the order form[10].
Long-term deferral status	If you repeatedly need > 6 donations/yr or can’t keep Hct below 54%, some centers reclassify you as therapeutic only and block online self-scheduling[7].	Patients are “indefinitely deferred” from volunteer donation once enrolled—re-entry requires a physician letter stating phlebotomy is no longer medically needed[10].

Practical Impacts for TRT Patients
· Most TRT users can donate like anyone else as long as labs and screening questions clear. Tell the screener about TRT so plasma/platelets aren’t distributed, but expect no extra paperwork at 56-day intervals.
· If your doctor wants labs below 54% Hct sooner than 56 days, expect to fill out a therapeutic-phlebotomy form and possibly pay a fee unless your local center explicitly waives it.
· Frequent donors may become indispensable: studies show TRT donors make up ~2% of the donor base yet contribute > 2% of red-cell supply because they donate more often[15].
· Policy downside: discarding plasma and platelets means 40–50% of each whole-blood unit is wasted, so some centers quietly discourage repeat TRT therapeutic draws if RBC inventory is full.
· Future eligibility could tighten or loosen depending on ongoing FDA review of testosterone levels found in stored RBCs[6]. For now, red-cells-only remains the national standard.
Staying on the volunteer path (free, minimal hassle) therefore hinges on keeping hematocrit under control with 8-week donations or dose adjustments; once you cross into physician-ordered high-frequency phlebotomy, additional paperwork, potential fees, and scheduling limits apply.

1. https://www.carterbloodcare.org/education-center/types-of-donations/testosterone-therapy/
2. https://weareblood.org/donate-blood/eligibility/
3. https://www.giveblood.org/donate/types-of-donations/therapeutic-phlebotomy-form/
4. https://www.oneblood.org/content/dam/oneblood/Form-96.pdf
5. https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/resources/ask-the-fda-and-clia-transcripts/2014-ask-the-fda-and-clia-transcript
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC8568643/
7. https://weareblood.org/therapeutic-phlebotomy/
8. https://www.fda.gov/files/vaccines, blood & biologics/published/Exceptions-and-Alternative-Procedures----Approved-Under-21-CFR-640.120.pdf
9. https://weareblood.org/wp-content/uploads/2020/08/F.0986.01-Testosterone-Therapy-Program-Enrollment-ONLY-Prescription06172020.pdf
10. https://www.lifesouth.org/wp-content/uploads/2024/06/Therapeutic_Phlebotomy_Order-1.pdf
11. https://www.vitalant.org/eligibility/hh-tt
12. https://www.vitalanthealth.org/getattachment/b1dd42fb-1ef8-4db9-935e-f81e00942de5/BS_365T.pdf
13. https://www.redcrossblood.org/donate-blood/how-to-donate/eligibility-requirements.html
14. https://www.vitalant.org/eligibility/additional-eligibility-requirements
15. https://pmc.ncbi.nlm.nih.gov/articles/PMC7643804/