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Test Code LAB1530 Prolonged Clot Time Profile, Plasma

Additional Codes

Test Name in EPIC EPIC Test Code Mnemonic Mayo Test ID
Prolonged Clot Time Profile LAB1530 APROL APROL

 


Ordering Guidance


Multiple coagulation profile tests are available. See Coagulation Profile Comparison for testing that is performed with each profile.



Shipping Instructions


Send the 5 aliquots in the same shipping container.



Necessary Information


Note if patient is currently receiving heparin, warfarin or any medication affecting coagulation.



Specimen Required


Specimen Type: Platelet-poor plasma

Patient Preparation:

1. Patient should not be receiving anticoagulant treatment (eg, warfarin, heparin). If not possible for medical reasons, note on request.

 a. If medically feasible, for 4 to 6 hours before specimen collection, do not administer intravenous heparin.

 b. If medically feasible, for 10 to 14 days before specimen collection, do not administer subcutaneous heparin or warfarin.

2. Patient should not be receiving fibrinolytic agents (streptokinase, urokinase, tissue plasminogen activator [tPA]).

3. It is recommended that specimens be collected pretransfusion. If patient has been transfused, a specimen should not be collected for 48 hours.

Collection Container/Tube: Light-blue top (3.2% sodium citrate)

Submission Container/Tube: Plastic vial

Specimen Volume: 5 mL Platelet-poor plasma in 5 plastic vials, each containing 1 mL

Collection Instructions:

1. Specimen must be collected prior to factor replacement therapy.

2. For complete instructions, see Coagulation Guidelines for Specimen Handling and Processing.

3. Centrifuge, transfer all plasma into a plastic vial, and centrifuge plasma again.

4. Aliquot plasma (1-2 mL per aliquot) into 5 separate plastic vials leaving 0.25 mL in the bottom of centrifuged vial.

5. Immediately freeze plasma (no longer than 4 hours after collection) at -20° C or, ideally, -40° C or below.

Additional Information:

1. Double-centrifuged specimen is critical for accurate results as platelet contamination may cause spurious results.

2. Each coagulation assay requested should have its own vial.


Forms

1. Coagulation Patient Information (T675)

2. If not ordering electronically, complete, print, and send a Coagulation Test Request (T753) with the specimen.

Useful For

Determining the cause of prolongation of prothrombin time or activated partial thromboplastin time

 

Screening for prolonged clotting times and determining the presence of factor deficiencies or inhibitor (eg, factor-specific, lupus-like, or the presence of heparin)

Profile Information

Test ID Reporting Name Available Separately Always Performed
APRI Prolonged Clot Time Prof Interp No Yes
PTSC Prothrombin Time (PT), P Yes, (order PTTP) Yes
APTSC Activated Partial Thrombopl Time, P Yes, (order APTTP) Yes
DRV1 Dilute Russells Viper Venom Time, P Yes, (order DRVI1) Yes
TTSC Thrombin Time (Bovine), P Yes Yes
CLFIB Fibrinogen, Clauss, P Yes, (order FIBTP) Yes
DIMER D-Dimer, P Yes, (order DDITT) Yes

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
GBETH General Factor Bethesda Units, P No No
5BETH FV Bethesda Units, P No No
8BETH FVIII Bethesda Units, P No No
9BETH FIX Bethesda Units, P No No
F8IS Coag Factor VIII Assay Inhib Scrn,P No No
FACTV Coag Factor V Assay, P Yes No
F_7 Coag Factor VII Assay, P Yes No
F_9 Coag Factor IX Assay, P Yes No
F_10 Coag Factor X Assay, P Yes No
F_11 Coag Factor XI Assay, P Yes No
F_12 Coag Factor XII Assay, P Yes No
F8A Coag Factor VIII Activity Assay, P Yes No
RTSC Reptilase Time, P Yes No
F_2 Coag Factor II Assay, P Yes No
PNP Platelet Neutralization Procedure No No
PTMSC PT Mix 1:1 No No
APMSC APTT Mix 1:1 No No
DRV2 DRVVT Mix No No
DRV3 DRVVT Confirmation No No
F5_IS Factor V Inhib Scrn No No
F9_IS Factor IX Inhib Scrn No No
F2_IS Factor II Inhib Scrn No No
F7_IS Factor VII Inhib Scrn No No
10_IS Factor X Inhib Scrn No No
11_IS Factor XI Inhib Scrn No No
PTFIB PT-Fibrinogen, P No No
SOLFM Soluble Fibrin Monomer No No
CH9 Chromogenic FIX, P Yes No
CHF8 Chromogenic FVIII, P Yes No
HEXLA HEX LA, P No No

Testing Algorithm

Initial testing includes prothrombin time (PT), activated partial thromboplastin time (aPTT), dilute Russell's viper venom time (dRVVT), thrombin time (bovine), fibrinogen, D-dimer, and prolonged clot time interpretation.

 

If the PT is greater than 13.9 seconds, then the PT mix will be performed at an additional charge.

 

If the aPTT is greater or equal to 38 seconds, then the aPTT mix will be performed at an additional charge.

 

If the aPTT mix is greater or equal to 38 seconds and thrombin time is less than 35.0 seconds (no evidence of heparin), then the platelet neutralization procedure will be performed at an additional charge.

 

If the dRVVT ratio is greater or equal to 1.20, then the dRVVT mix and dRVVT confirmation will be performed at an additional charge.

 

If the thrombin time is greater or equal to 25.0 seconds, then the reptilase time will be performed at an additional charge.

 

If fibrinogen is less than 150 mg/dL or clinically indicated, then the PT-fibrinogen will be performed at an additional charge.

 

If D-dimer is greater than 500 ng/mL fibrinogen equivalent units, then soluble fibrin monomer testing will be performed at an additional charge.

 

If the PT, aPTT, or aRVVT are prolonged, then coagulation factor assays may be performed at an additional charge.

 

If a factor assay result is below the normal range, the appropriate factor inhibitor screen may be performed along with the Bethesda titering assay, at an additional charge, if inhibitor screen is positive.

 

If appropriate, hexagonal lupus anticoagulant will be performed at an additional charge to clarify significant abnormalities in the screen test results.

Method Name

ARPI: Medical Interpretation

PTSC, APTSC, DRV1, TTSC, GBETH, 5BETH, 8BETH, 9BETH, F8IS, FACTV, F_2, F_7, F_9, F_10, F_11, F_12, F8A, RTSC, PNP, APMSC, PTMSC, PTFIB, DRV2, DRV3: Optical Clot-Based

CLFIB: Clauss

DIMER, SOLFM: Latex Immunoassay (LIA)

CH9, CHF8: Chromogenic

HEXLA: Spectrophotometry

Reporting Name

Prolonged Clot Time Prof

Specimen Type

Plasma Na Cit

Specimen Minimum Volume

Platelet-poor plasma: 4 plastic vials, each containing 1 mL

Specimen Stability Information

Specimen Type Temperature Time
Plasma Na Cit Frozen 14 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Clinical Information

When coagulation screening tests are performed to verify normal function of the coagulation system (eg, preoperative, routine examination), they sometimes indicate an abnormality that may be unexplained (ie, prolonged clotting times). This consultation provides validation of the prolongation and as comprehensive a workup as needed to define the abnormality.

 

Possibilities for a cause of prolongation include:

-Artifactual due to high hematocrit (dilution of specimen by anticoagulant if patient hematocrit is 55% or greater)

-Factor deficiencies, congenital or acquired

-Factor inhibitors eg, factor VIII inhibitors (bleeding disorder)

-Lupus anticoagulant (risk for thrombosis or recurrent miscarriage)

-Anticoagulant drug effect eg, (including warfarin [Jantoven], oral anti-Xa inhibitors, oral direct thrombin inhibitors), heparin.

Reference Values

An interpretive report will be provided.

 

PROTHROMBIN TIME (PT):

Prothrombin time: 9.4-12.5 seconds

International normalized ratio (INR):

0.9-1.1

Standard intensity warfarin therapeutic range: 2.0-3.0

High intensity warfarin therapeutic range: 2.5-3.5

 

ACTIVATED PARTIAL THROMBOPLASTIN TIME (aPTT):

25-37 seconds

The activated partial thromboplastin time (aPTT) may be 35% longer in full-term newborns that reach adult reference range by age 3 months and twice the adult upper limit in premature infants reaching adult reference range by age 6 months.

 

DILUTE RUSSELL'S VIPER VENOM TIME (dRVVT):

<1.20

Normal ranges for children: Not clearly established but similar to normal ranges for adults, except for newborn infants whose results may not reach adult values until age 3 to 6 months.

 

THROMBIN TIME (BOVINE):

15.8-24.9 seconds

 

FIBRINOGEN, CLAUSS:

Males: 200-500 mg/dL

Females: 200-500 mg/dL

In normal full-term newborns and in healthy premature infants (30-36 weeks gestation) fibrinogen is near adult levels (>150) and reaches adult levels by less than 21 days postnatal.

 

D-DIMER:

≤500 ng/mL Fibrinogen Equivalent Units (FEU)

D-dimer values ≤500 ng/mL FEU may be used in conjunction with clinical pretest probability to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE).

 

GENERAL FACTOR BETHESDA UNITS:

≤0.5 Bethesda Units

 

FACTOR V BETHESDA UNITS:

≤0.5 Bethesda Units

 

FACTOR VIII BETHESDA UNITS:

≤0.5 Bethesda Units

 

FACTOR IX BETHESDA UNITS:

≤0.4 Bethesda Units

 

COAGULATION FACTOR VIII INHIBITOR:

Negative

 

COAGULATION FACTOR V ACTIVITY ASSAY:

>1 month: 70%-165%

<1 month: Normal, full-term and premature newborn infants may have mildly decreased levels (≥30% to 35%) which reach adult levels within 21 days postnatal.

 

COAGULATION FACTOR VII ACTIVITY ASSAY:

Adults: 65-180%

Normal, full-term newborn infants or healthy premature infants may have decreased levels (≥20%) which increase within the first postnatal week but may not reach adult levels for ≥180 days postnatal.*

 

COAGULATION FACTOR IX ACTIVITY ASSAY:

≤6 months: Normal, full-term newborn infants or healthy premature infants may have decreased levels (≥20%), which may not reach adult levels for 180 or more days postnatal.* (Literature derived)

>6 months: 65-140%

 

COAGULATION FACTOR X ACTIVITY ASSAY:

Adults: 70-150%

Normal, full-term newborn infants or healthy premature infants may have decreased levels (≥15-20%), which may not reach adult levels for 180 or more days postnatal.*

 

COAGULATION FACTOR XI ACTIVITY ASSAY:

Adults: 55-150%

Normal, full-term newborn infants or healthy premature infants may have decreased levels (≥10%), which may not reach adult levels for 180 or more days postnatal.*

 

COAGULATION FACTOR XII ACTIVITY ASSAY:

Adults: 55-180%

Normal, full-term newborn infants or healthy premature infants may have decreased levels (≥15% to 20%), which may not reach adult levels for 180 or more days postnatal.*

 

COAGULATION FACTOR VIII ACTIVITY ASSAY:

Adults: 55-200%

Normal, full-term newborn infants or healthy premature infants typically have levels greater than or equal to 40%.*

 

REPTILASE TIME:

14.0-23.9 Seconds

 

COAGULATION FACTOR II ACTIVITY ASSAY

Adults: 75-145%

Normal, full-term newborn infants or healthy premature infants may have decreased levels (≥25%) which may remain below adult levels for ≥180 days postnatal.*

 

PLATELET NEUTRALIZATION PROCEDURE:

An interpretive report will be provided.

 

PROTHROMBIN TIME MIX 1:1:

9.4-12.5 seconds

 

ACTIVATED PARTIAL THROMBOPLASTIN TIME (aPTT) MIX 1:1:

25-37 seconds

 

DILUTE RUSSELL'S VIPER VENOM TIME (dRVVT) MIX

<1.20

Normal ranges for children: Not clearly established but similar to normal ranges for adults, except for newborn infants whose results may not reach adult values until age 3 to 6 months.

 

DILUTE RUSSELL'S VIPER VENOM TIME (dRVVT) CONFIRMATION:

<1.20

Normal ranges for children: Not clearly established but similar to normal ranges for adults, except for newborn infants whose results may not reach adult values until age 3 to 6 months.

 

FACTOR V INHIBITOR:

Negative

 

FACTOR IX INHIBITOR:

Negative

 

FACTOR II INHIBITOR:

Negative

 

FACTOR VII INHIBITOR:

Negative

 

FACTOR X INHIBITOR SCREEN:

Negative

 

FACTOR XI INHIBITOR:

Negative

 

PT-FIBRINOGEN:

261-595 mg/dL

In normal full-term newborns and in healthy premature infants (30-36 weeks gestation), fibrinogen is near adult levels (>150) and remains at adult levels throughout childhood.

 

SOLUBLE FIBRIN MONOMER:

≤8 mcg/mL

 

CHROMOGENIC FACTOR IX ACTIVITY ASSAY:

65-140%

Chromogenic factor IX activity generally correlates with the one-stage FIX activity. In full term/premature neonates, infants, children, and adolescents the one-stage FIX activity* is similar to adults. However, no similar data for chromogenic FIX activity are available.**

 

CHROMOGENIC FACTOR VIII ACTIVITY ASSAY:

55.0-200.0%

Chromogenic factor VIII activity generally correlates with the one-stage FVIII activity. In full term/premature neonates, infants, children, and adolescents the one-stage FVIII activity* is similar to adults. However, no similar data for chromogenic FVIII activity are available.**

 

HEXAGONAL LUPUS ANTICOAGULANT:

<13 seconds

 

*See Pediatric Hemostasis References section in Coagulation Guidelines for Specimen Handling and Processing

 

**Appel IM, Grimminck B, Geerts J, Stigter R, Cnossen MH, Beishuizen A. Age dependency of coagulation parameters during childhood and puberty. J Thromb Haemost. 2012;10[11]:2254-2263

Interpretation

An interpretive report will be provided when testing is completed, noting a presence or absence of a prolonged bleeding disease state.

Cautions

If the patient's hematocrit is 55% or greater, the volume of citrate anticoagulant should be adjusted prior to submitting the specimen for analysis to avoid dilution of plasma by anticoagulant.(1)

 

For optimal results, the patient should not be receiving oral vitamin K inhibitor (eg, warfarin), heparin, low-molecular weight heparin, hirudin (Refludan), argatroban, or fibrinolytic agents (eg, streptokinase, tissue plasminogen activator). If necessary, testing may be performed on patients receiving these treatments. Medications affecting coagulation parameters must be noted on requisition for accurate interpretation of results. Treatment with heparin causes false-positive results of in vitro coagulation testing for lupus anticoagulant. Coumadin treatment may impair ability to detect the more subtle varieties of lupus-like anticoagulants.

Method Description

Prothrombin time:

The prothrombin time (PT) assay is performed on the Instrumentation Laboratory ACL TOP. Patient sample is incubated and combined with a PT reagent containing recombinant human tissue factor, synthetic phospholipids, calcium chloride, polybrene, and buffer. The tissue thromboplastin-factor VII/VIIa complex activates factor X. Activated factor X (factor Xa) forms a complex with factor Va, calcium, and phospholipid to activate factor II (prothrombin) to thrombin. Thrombin then acts on fibrinogen (factor I) to form fibrin which clots, the time to clot formation is measured optically using a wavelength of 671 nm providing the assay endpoint (the "prothrombin time").(Package insert: HemosIL RecombiPlasTin 2G. Instrumentation Laboratory Company; R0, 03/2019)

 

Activated Partial Thromboplastin Time:

The activated partial thromboplastin time (aPTT) assay is performed on the Instrumentation Laboratory ACL TOP. Patient sample is combined and incubated with an aPTT reagent containing phospholipid, a negatively charged contact factor activator, and buffer. After a specified incubation time, calcium is added to trigger the coagulation process in the mixture. Subsequently, the time to clot formation is measured optically using a wavelength of 671 nm. Mixing studies (APMSC / Activated Partial Thromboplastin Time [APTT] Mix 1:1, Plasma) using normal pooled plasma are performed on samples with a prolonged aPTT to assist in discriminating between factor deficiency states and coagulation inhibitors unless further testing is not indicated.(Package insert: HemosIL SynthASil. Instrumentation Laboratory Company; R11, 06/2017)

 

Dilute Russell's Viper Venom Time:

The dilute Russell's viper venom time (dRVVT) screening assay is performed on the Beckman Coulter ACL TOP. Patient sample is incubated for a specified time, then combined with a dRVVT screening reagent containing Russell's viper venom, phospholipids, heparin neutralizing agents, calcium, buffers, and stabilizers to trigger the coagulation process. Subsequently, the time to clot formation is measured optically using a wavelength of 671 nm. The patient dRVVT screening clotting time is normalized by dividing the patient result by the mean dRVVT screening clotting time of normal pooled plasma to yield a ratio (dRVVT screen ratio).(Package insert: LA CHECK DRVVT. Precision Biologic; R14, 03/2012)

 

Thrombin Time:

The thrombin time assay is performed on the Instrumentation Laboratory ACL TOP. Patient sample is combined with a bovine thrombin reagent containing bovine albumin, calcium chloride, and buffer immediately triggering the coagulation process in the mixture. Time to clot formation is measured optically using a wavelength of 671 nm.(Package insert: HemosIL Thrombin Time. Instrumentation Laboratory Company; R1, 12/2018)

 

Fibrinogen, Clauss assay:

The Clauss fibrinogen assay is performed using the HemosIL Fibrinogen-C kit on the Instrumentation Laboratory ACL TOP. Patient sample, containing fibrinogen, is mixed with reagent containing excess thrombin. The excess thrombin converts the fibrinogen in the patient sample to fibrin. The amount of time it takes to form a clot is inversely proportional to the amount of fibrinogen present in the patient sample.(Package insert: HemosIL Fibrinogen-C. Instrumentation Laboratory Company; R7, 06/2017)

 

D-Dimer:

The D-dimer assay is performed using the HemosIL D-Dimer HS 500 kit on the Instrumentation Laboratory ACL TOP instrument. D-dimer is assayed in plasma by adding polystyrene latex particles coated with monoclonal antibodies specific for D-dimer domain. The latex particles agglutinate in the presence of soluble fibrin degradation products containing the D-dimer domain. The degree of agglutination is directly proportional to the concentration of D-dimer in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates (turbidimetric immunoassay).(Package insert: HemosIL D-Dimer HS 500. Instrumentation Laboratory Company; 04/2018)

Day(s) Performed

Monday through Friday

Report Available

3 to 7 days

Specimen Retention Time

7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

See Individual Test IDs

CPT Code Information

85379-DIMER

85384-CLFIB

85390-26-APRI

85610-PTSC

85613-DRV1

85670-TTSC

85730-APTSC

85130-Chromogenic FVIII (if appropriate)

85130-Chromogenic FIX (if appropriate)

85210-Factor II (if appropriate)

85220-Factor V (if appropriate)

85230-Factor VII (if appropriate)

85240-Factor VIII (if appropriate)

85250-Factor IX (if appropriate)

85260-Factor X (if appropriate)

85270-Factor XI (if appropriate)

85280-Factor XII (if appropriate)

85335-Bethesda titer (if appropriate)

85335-Factor V inhibitor screen (if appropriate)

85335-Factor VIII inhibitor screen (if appropriate)

85335-Factor IX inhibitor screen (if appropriate)

85366-Soluble fibrin monomer (if appropriate)

85385-PT-Fibrinogen (if appropriate)

85597-Platelet neutralization for lupus inhibitor (if appropriate)

85598-Hex LA (if appropriate)

85611-PT mix 1:1 (if appropriate)

85613-DRVVT mix (if appropriate)

85613-DRVVT confirm (if appropriate)

85635-Reptilase time (if appropriate)

85732-APTT mix 1:1 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
APROL Prolonged Clot Time Prof 98125-8

 

Result ID Test Result Name Result LOINC Value
603324 Reviewed by 18771-6
CLFIB Fibrinogen, Clauss, P 48664-7
RVR1 DRVVT Screen Ratio 15359-3
TTSC Thrombin Time (Bovine), P 46717-5
APTSC Activated Partial Thrombopl Time, P 14979-9
PTSEC Prothrombin Time (PT), P 5902-2
603183 Prolonged Clot Time Prof Interp 69049-5
DIMER D-Dimer, P In Process
INRSC INR 6301-6