Tranexamic Acid in Gynaecology & Obstetrics

Tranexamic Acid in Gynaecology
& Obstetrics
Prof. Surendra Nath Panda, M.S.

Dept. of Obstetrics and Gynecology
M.K.C.G.Medical College, Berhampur.
Blood The essence of Life
STOP STOP
BLOOD LOSS BLOOD LOSS
LIFE GOES ON
06:12 Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002 2

Women are always at Risk of
Loosing Blood
FROM MENARCHEE TO
PPH MENOPAUSE DUB
IN NORMALCY OR CX
DUB
PREGNANCY
APH DUB
IN HEALTH OR DISEASE
HOW TO STOP IT?

Events in Hemostasis
1) Vasoconstriction
3) Blood clotting
2) Platelet plug formation
4) Fibrinolysis
Events in Haemostasis
COAGULATION:
Prothrombin Thrombin
Fibrinogen Fibrin
forms
Clot

Events in Haemostasis
FIBRINOLYSIS:
Plasminogen Plasmin
dissolves
Clot

COAGULATION
AND FIBRINOLYSIS

Presenting Tranexamic Acid
Tranexamic
COAGULATION
TRANEXAMIC
AND FIBRINOLYSIS
ACID
Acid

Tranexamic Acid
Synthetic amino acid, first introduced in Sweden

in1969.
Chemically it is Tranexamic-stereo isomer of 1, 4, -
aminomethylcyclohexane carboxylic acid.
Formula C8H15NO2.
Molecular Wt.-157.
Prevents fibrinolysis and breakdown of clot.
It is a competitive inhibitor of plasminogen activation.
At very high concentration, it is also a non competitive
inhibitor of Plasmin.
It is also a very weak inhibitor of thrombin.

Tranexamic Acid
Mechanism of Action
Tranexamic acid inhibits conversion of
plasminogen to plasmin, hence prevents
breakdown of clot.
Increases collagen synthesis which preserves
the fibrin matrix and increases the tensile
strength of the clot
These actions of Tranexamic acid help in
stabilizing the clot

Tranexamic Acid
Pharmacokinetics
Absorption after oral administration is 30-50%
Food has no influence on absorption
Presystemic metabolism ~ nil
Plasma half-life ~ 1.4h
Is able to cross the blood-aqueous barrier in the
eyes.
Can also cross the damaged blood-brain barrier
Rapidly diffuses into joint fluid and the synovial
membrane.

Tranexamic Acid
Pharmacokinetics
Plasma protein binding is negligible
Undergoes negligible metabolism in the body.
Mainly eliminated unchanged in the urine.
Excretion occurs by glomerular filtration via
the kidneys.
Passes through the placenta and its
concentration in the cord blood may reach
that of maternal blood.

Tranexamic Acid
Clinical Pharmacology
The antifibrinolytic effect of Tranexamic acid
is related mainly to a reversible complex
formation with plasminogen, which prevents
its activation to plasmin.
Tranexamic acid is 7 to 10 times more potent
than Epsoilon-aminocaproic acid [EACA].
Tranexamic acid produces a considerably
higher and more sustained antifbrinolytic
activity in tissues than does EACA.

Tranexamic Acid
Clinical Pharmacology
Adverse effects- are rare and mainly limited
to
Nausea, Vomiting & Diarrhea, Allergy and
occasionally an Orthostatic reaction.
There is a theoretical risk of an increased
thrombotic tendency, like deep vein thrombosis,
during prolonged treatment as with any
fibrinolysis inhibitors.
Contraindications: -
Severe renal insufficiency
Hematuria
Tranexamic Acid
Pregnancy And Lactation
Pregnancy:Tranexamic acid crosses over to the
foetus. It is not known whether a reduction of the
normally high fibrinolytic activity in the foetus and
neonate is harmful.
Lactation:Tranexamic acid is secreted in the mother's
milk. This concentration is only a hundredth of the
corresponding serum levels and the drug may be
given during lactation without risk to the child.
Ref: Collin Dollery. Tranexamic Acid. In 'Therapeutic Drugs. 2nd edition.
1999.pgT150-T153
Tranexamic Acid
Uses in OBGYN
To Prevent / reduce blood loss in: -
Dysfunctional Uterine Bleeding
IUD Menorrhagia.
Conization / Amputation of Cervix.
Post Partum Hemorrhage.
Ante Partum Hemorrhage.
During/After Abdominal/Vaginal Surgery
Available in both Oral and Inj. (IV) forms
Dysfunctional Uterine Bleeding
Most common menstrual disorder.
Can affect any women from menarche to
menopause.
Often the first clinical diagnosis for any
excessive menstrual bleedings.
Diagnosis has to be confirmed by a process
of exclusion of pathological causes.

Types of DUB
OVULATION PHASE END. HIST MENSTRUAL
CHANGE PATERN
NORMAL SHORTENED F P NORMAL POLYMENORRHAGIA

MENORRHAGIA
NORMAL LONG F P NORMAL OLIGOMENORRHOEA
MENORRHAGIA
ABNORMAL SHORT L P DEFICIENT PRE MENS. SPOTTING
COR.LUT SEC. END. MENORHAGIA
PERSISTENT LONG L P WELL DEV. SEC. PROLONGED CYCLES

COR. LUT END
ANOVULATION SHORT CYCLES DEFICIENT POLYMENORRHAGIA
(Insufficient follicles) PRO. END. MENORRHAGIA
PROL. CYCLES PRO. / OLIGOMENORRHOEA

ANOVULATION
(Polycystic HYPERPLASTIC METROPATHIA
Ovaries) HAEMORRHAGICA
Dysfunctional Uterine Bleeding-WHY?
Exact pathophysiology still not known.

Basis of excessive bleeding?
Endocrine abnormality: -estrogen - progesterone
imbalance (usually estrogen dominance).
Deficiency in clotting mechanism.
Altered prostaglandin synthesis in favor of E2
than F2.

D U B - Management Options
D&C
CONSERVATIVE (ES+H)
MEDICAL

SPONTANEOUS
CURE
RECURENCE / CURE
FAILURE
D & C / H+ES H-Hysteroscopy
ES-Endometrial Sampling
-SURGERY-
-HYSTERCTOMY
-ENDOMETRIAL ABLATION
Medical Treatment for DUB
HORMONES ANTIFIBRINOLYTICS
Es+Pr (COCP) TRANEXAMIC ACID
Progestogens (TA)
Norethisterone? Epsilon Amino Caproic
MPA Acid
LNG IUS NSAIDs
Danazol Mefenamic acid (MA)
GnRHa Naproxen,Ibuprofen,
Estrogen Aspirin
Androgens + Estrogen SERMS
Ethamsylate Radiotherapy ??

Evidence Based Medicine
(E B M)
Evidence-Based Medical Treatment for DUB may
be
Grade A - based on randomized controlled trials.
Grade B - based on other robust. experimental or
observational studies.
Grade C - based on more limited evidence but
the advice relies on expert opinion and has the
endorsement of respected authorities.

COC Pills
Combined oral contraceptives (COCs) can be used to reduce
menstrual blood loss (A) [RCOG, 1998].
They are thought to reduce blood loss by inducing regular
shedding of a thinner endometrium.
In one small randomized trial, the COC reduced menstrual
blood loss by 43% and was as effective as mefenamic acid,
naproxen, and low dose danazol [Iyer et al. 2001].
The effectiveness of the COC at reducing menstrual blood
loss is supported by other non-randomized and non-
controlled studies [RCOG, 1998].
The COC is a reasonable first choice for women who also
require contraception.
In addition, it may reduce associated dysmenorrhoea [Wilson
et al. 2001].

LNG IUS
A progestogen releasing intrauterine device is an effective
treatment for menorrhagia (A)
It reduces menstrual blood loss by up to 90%
Its main advantages are relief of dysmenorrhoea, effective
contraception, and long-term control of menorrhagia
following insertion [Sturridge and Guillebaud, 1996].
Satisfaction and quality of life ratings are high, although there
is a lack of data comparing it to other established treatments.
It is much cheaper over 5 years compared to other
treatments, although it becomes expensive if removed before
that time limit.
The main disadvantages are intermenstrual bleeding and
breast tenderness in the first few months following insertion.
Expulsion rates range from 3.3-5.9% within 12 months
[Lethaby et al. 2001e].

NASIDs
Mefenamic acid is an effective treatment for reducing heavy
menstrual blood loss (A) [RCOG, 1998].
Although mefenamic acid has been studied the most, it is
likely that other nonsteroidal anti-inflammatory drugs
(NSAIDs) are as effective [Lethaby et al. 2001a].
NSAIDs are thought to act by reducing uterine prostaglandin
levels, which are elevated in women with excessive
menstrual bleeding.
NSAIDs reduce menstrual blood loss by 20-50% [RCOG,
1998].
Comparative studies show that they are less effective than
tranexamic acid or danazol, but are as effective as other
medical treatments [Duckitt, 2000; Lethaby et al. 2001a].
They reduce associated dysmenorrhoea [Zhang and Li Wan
Po, 1998; Wilson and Farquhar, 2000].

Tranexamic Acid
Tranexamic acid is an effective treatment for
reducing heavy menstrual blood loss (A) [RCOG,
1998].
It reduces menstrual blood loss by 40-50%
[Lethaby et al. 2001b].
Being a plasminogen activator inhibitor, its use is
rational as an increase in the level of plasminogen
activators is found in the endometrium of women
with heavy menstrual bleeding compared to those
with normal menstrual loss.

Tranexamic Acid
Comparative studies show it to be more effective in
reducing menstrual blood loss [RCOG, 1998; Duckitt, 2000;
Lethaby et al. 2001b]. than
nonsteroidal anti-inflammatory drugs,
luteal phase oral progestogens, and
ethamsylate
It has not been compared to the combined oral
contraceptive pill or the levonorgestrel intrauterine system.
It is well tolerated, with no significant increase in reported
adverse events compared to placebo or other treatments
[Lethaby et al. 2001b].
There is no evidence of an increased incidence of
thrombogenic disease (e.g. deep vein thrombosis) [RCOG,
1998; Lethaby et al. 2001b].

Danazol
Danazol inhibits secretion of pituitary
gonadotrophins and also has androgenic, anti-
oestrogenic, and anti-progestogenic activity.
It reduces excessive menstrual bleeding by up to
80% [NZ, 1998; RCOG, 1999].
It is poorly tolerated, due to androgenic side effects
of weight gain, hirsutism, acne, mood changes, and
occasionally deepening of the voice, which may be
irreversible.
It should generally only be used selectively,
following specialist advice [NZ, 1998; RCOG, 1998].

Ethamsylate
Ethamsylate is thought to reduce capillary
bleeding by correcting abnormal platelet
function.
There is some evidence that it may achieve
small reductions in menstrual blood loss, but
this is unlikely to be clinically significant
[RCOG, 1998; Duckitt, 2000].
Ethamsylate, at currently recommended
doses, is not an effective treatment for
menorrhagia (A) [RCOG, 1998].
GnRHa
Gondadotrophin releasing hormone analogues initially
stimulate pituitary secretion of gonadotrophins and then
rapidly inhibit secretion due to pituitary down-regulation.
This results in anovulation, markedly reduced oestrogen
levels, and amenorrhoea.
They are poorly tolerated and cannot be used long-term.
They should only be used selectively following
specialist advice [RCOG, 1998].
Some are licensed for endometrial thinning prior to
intrauterine surgery or for reduction of size of uterine
fibroids and associated bleeding before surgery.

Progestogens (oral)
Several reviews have highlighted the lack of good trial data
and the likely poor efficacy of commonly used regimes
[EHCB, 1995; NZ, 1998; RCOG, 1998; Duckitt, 2000;
Lethaby et al. 2001c].
Low dose, luteal phase administration of norethisterone is
not an effective treatment for menorrhagia (A) [RCOG, 1998].
Luteal phase progestogens (taken from Day 15 or 19 to Day
26 of the cycle) have not been studied in placebo-controlled
trials, but comparative studies indicate that they are inferior
to other medical treatments [Lethaby et al. 2001c].
Progestogen treatment for 21 days of each cycle reduces
menstrual blood loss by about 90%, but is poorly tolerated. In
one study, only 22% of women were willing to continue
treatment [RCOG, 1998; Duckitt, 2000; Lethaby et al. 2001c].
Norethisterone 15 mg daily for 10 days is licensed to arrest
menstrual bleeding, and may be useful for some women who
present with heavy, prolonged bleeding [BNF 41, 2001
Progestogens (long-acting)
Continued use of long-acting progestogens renders most
women amenorrhoeic and therefore could be considered for
use in menorrhagia (C) [RCOG, 1998].
However, there is no trial data available on their use in the
treatment of menorrhagia and they are not licensed for this
indication.
Medroxyprogesterone acetate (MPA) is available as a depot
injection for contraception. It may cause unpredictable,
irregular spotting and bleeding in the first few months of use,
and may cause heavy bleeding in 1-2% of women. However,
after using it for a year, 45-50% of women are amenorrhoeic
[RCOG, 1998].
MPA may be an option for women who require contraception
but who are unable or unwilling to use the combined oral
contraceptive pill or the levonorgestrel intrauterine system.

EBM
Treatment of Menorrhagia during menstruation:
randomized controlled trial of Ethamsylate,
Mefenamic acid, and Tranexamic acid
John Bonnar, Professor and Head of Department, Brian L Sheppard, Associate
Professor of Human Reproduction
Trinity College Department of Obstetrics and Gynaecology, Trinity Centre for
Health Sciences, St James' Hospital and The Coombe Women's Hospital, Dublin
BMJ. 1996;313:579-582
Objective: To compare the efficacy and acceptability of
Ethamsylate, Mefenamic acid, and Tranexamic acid for
treating Menorrhagia.

EBM
Design: Randomized controlled trial.
Setting: A university department of obstetrics and gynaecology.
Subjects: 76 women with dysfunctional uterine bleeding.
Interventions: Treatment for five days from day 1 of menses during three
consecutive menstrual periods. 27 patients were randomised to take ethamsylate
500 mg six hourly, 23 patients to take mefenamic acid 500 mg eight hourly, and
26 patients to take tranexamic acid 1 g six hourly
Main outcome measures: Menstrual loss measured by the alkaline haematin

method in three control menstrual periods and three menstrual periods during
treatment; duration of bleeding; patient's estimation of blood loss; sanitary towel
usage; the occurrence of dysmenorrhoea; and unwanted events.

EBM
Results
Fig 1--Mean menstrual blood loss of
27 patients during three pretreatment
(control) cycles and three cycles
during treatment with ethamsylate,
cycles and three cycles during
treatment with mefenamic acid, and
cycles and three cycles during
treatment with tranexamic acid. Bars
are SD

EBM
Results
Fig 2--Mean menstrual blood loss
during three control and three
treatment cycles in patients treated
with ethamsylate (no reduction in
blood loss), mefenamic acid (20%
reduction in blood loss), and
tranexamic acid (54% reduction in
blood loss). Bars are SD

EBM
Conclusions:
Tranexamic acid given during menstruation is a safe
and highly effective treatment for excessive
bleeding.
Patients with dysfunctional uterine bleeding should
be offered medical treatment with Tranexamic acid
before a decision is made about surgery.
Antifibrinolytics for heavy menstrual bleeding
(Cochrane Review conclusions)
Antifibrinolytic therapy causes a greater reduction in
objective measurements of heavy menstrual bleeding when
compared to placebo or other medical therapies (NSAIDS,
oral luteal phase progestagens and ethamsylate).
This treatment is not associated with an increase in side
effects compared to placebo, NSAIDS, oral luteal phase
progestagens or ethamsylate.
Flooding and leakage and sex life is significantly improved
after tranexamic acid therapy when compared with oral luteal
progestogens but no other measures of quality of life were
assessed.
No study has used resource cost as an outcome.
There are no data available within randomised controlled
trials which record the frequency of thromboembolic events.
From- The Cochrane Library, Issue 3, 2002. Oxford: Lethaby A, Farquhar
C, Cooke
Evidence-Based Treatment for DUB
Effective treatments for Menorrhagia: -

Tranexamic acid
Non-steroidal anti-inflammatory drugs
Combined oral contraceptives
Cyclical (21 days) progestogens
The Levo Norgestrel releasing intrauterine
system (LNG IUS / Mirena)
Inappropriate management is being applied even though effective
medical treatments exist (above) and have a rational basis for their
use. Increased use of effective treatments will improve patient
choice and provide an alternative to surgery.
Reduction in Menstrual Blood
Loss by Drugs
120
97 97
100 Ethymsylate
TA
Norethisterone
80 MA NASID (MA)
Percent
60 COCP
60 50 Tranexamic Acid
40
40 Danzol
30
GNRha
20 15 LNG IUS
5
0

Hormonal Treatment for DUB
Problems: -
Treatment has to be individualized.
Not suitable for all ages and all types.
Response is erratic and unpredictable.
SIDE EFFECTS So discontinuation and
noncompliance.
Failures are common.
Cost effectiveness?
Surgery is often resorted to.
Final Verdict on Tranexamic Acid
EBM
It is the most effective and acceptable of
the drug therapies currently available for
DUB.
It induces a reduction in menstrual blood
loss of around 50% in the majority of
patients.
However, Tranexamic acid is ineffective in
around 15% of patients, and
Its acceptability is compromised in
approximately 20-30% of patients, due to
the side effects.

Guidelines and Statements From
Governmental Agencies and Professional
Associations were also reviewed
United Kingdom
Cochrane Menstrual Disorders and Subfertility Group
(Cochrane Collaboration)
Disorders of the Menstrual Cycle (Royal College of
Obstetricians and Gynaecologists, UK)
Menorrhagia (Prodigy, UK)
North Essex Guidelines For The Management Of
Menorrhagia In Primary Care (Equip, UK)
The Initial Management of Menorrhagia (Royal College of
Obstetricians and Gynaecologists, UK)
The Management of Menorrhagia in Secondary Care
(Royal College of Obstetricians and Gynaecologists, UK)

United States
Abnormal Vaginal Bleeding (American College of
Radiology)
Menstrual disorders (American Board of Family Practice)
Surgical Alternatives to Hysterectomy for Abnormal
Uterine Bleeding (Minnesota Health Technology Advisory
Committee, US)
Canada
Guidelines for the Management of Abnormal Uterine
Bleeding (The Society of Obstetricians and
Gynaecologists of Canada)

Australia
IMB - Guidelines For Referral (Medicine Australia)
New Zealand
Guidelines for the Management of Heavy Menstrual
Bleeding (New Zealand Guidelines Group)
Recommended Medical Investigations and Treatment for
Heavy Menstrual Bleeding (New Zealand Guidelines
Group)

Treatment for Menorrhagia (DUB)
Current Recommendation
Does not need TA 1G TDS / M A 500mg TDS
contraception / / Both, from 1st day of period
prefers non hormonal for days of heavy flow (Not
treatment
more than 4 days)
If blood flow is reduced to
an acceptable level ,
continue treatment Use for 3 months
indefinitely.
If blood flow is not reduced to an
acceptable level or unacceptable side
effects, review and try other modalities.
Treatment for Menorrhagia (DUB)
Needs contraception / prefers hormonal treatment
21 days
COC Pills LNG IUS Cyclical MPA
+TA +TA / Long Acting
TA
Review after 3 months. Progestogens
Add MA if necessary.
Review after 6 months. If flow

still unacceptable reassess.
Review after 3 months.

Treatment for Menorrhagia (IUD)
Has an non T A 1G TDS alone / with
hormonal / or M A 500mg TDS,
IUCD from 1st day of period for
days of heavy flow (Not
more than 4 days)
If flow is not reduced to
an acceptable level or If blood flow is
unacceptable side reduced to an
effects, remove IUCD & acceptable level ,
suggest alternative continue treatment
contraception. indefinitely.
Tranexamic Acid for DUB
Summary
Tranexamic Acid in doses of 1G TDS/QDS is
a very safe and effective alternative.
Adding Mefenamic Acid 500mg TDS will
further improve the results specially in
patients having dysmenorhea as well.
It should be used as primary / first line of
treatment particularly where the cycle is
regular or contraception is not desired.
It can also be used along with OCP / MPA
where cycle control /contraception is required.
Tranexamic Acid in Conization
Post operative heavy bleeding after
knife conization occurs in about
15% of cases, requiring extra
measures.
High concentration of Plasminogen
has been observed in Cx.
Tranexamic Acid, is a logical
solution in such patients.
In doses of 1.5G/day for 12 days
post operatively, double blind
studies have shown a 70%
reduction in blood loss.

Tranexamic Acid in APH & PPH
Bleeding from placental sites usually result
from the structural weakness & defects in the
placental blood vessels.
Tranexamic acid in doses of 1G (IV/Oral)
TDS, by prtomoting stable coagulation at the
site of bleeding, can be of help in-
Placenta Previa (2nd half of pregnancy).
Abruptio Placentae.
Persistent Post Partum Hemorrhage

Blood The essence of Life
STOP BLOOD LOSS WITH

TRANEXAMIC ACID


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Tranexamic Acid in Gynaecology

Prof. Surendra Nath Panda, M.S.

06:12 Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002 2

HOW TO STOP IT?

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Synthetic amino acid, first introduced in Sweden

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NORMAL SHORTENED F P NORMAL POLYMENORRHAGIA

PERSISTENT LONG L P WELL DEV. SEC. PROLONGED CYCLES

PROL. CYCLES PRO. / OLIGOMENORRHOEA

Exact pathophysiology still not known.

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Main outcome measures: Menstrual loss measured by the alkaline haematin

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Effective treatments for Menorrhagia: -

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Review after 6 months. If flow

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STOP BLOOD LOSS WITH

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