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Thrombin Generation and Platelet Activation in CRS/HIPEC

Brief Summary

Cytoreductive surgery (CRS) with hyperthermic intraperitoneal peroperative chemotherapy (HIPEC), indicated for patients with peritoneal metastases from digestive or gynecological malignancies alike, demonstrates a considerable impact on hemostatic metabolism, both on platelet and on coagulation level. The potential hemostatic interference in CRS and HIPEC is phase dependent. This study demonstrates the combined use of ROTEM (rotational thromboelastometry), PACT (platelet activation test) and CAT (thrombin generation test) assays during CRS and HIPEC with a follow-up of 7 days postoperative.

Tracking Information
First Received DateJanuary 12, 2017
Last Changed DateJanuary 24, 2017
Start DateApril 2015
Actual Primary Completion DateJuly 2016
Primary Outcome Measures

Blood loss [Time Frame: From surgical incision to 7 days postoperative]

Secondary Outcome Measures

Red blood cell count [Time Frame: From surgical incision to 7 days postoperative]

White blood cell count [Time Frame: From surgical incision to 7 days postoperative]

Platelet count [Time Frame: From surgical incision to 7 days postoperative]

Fibrinogen levels [Time Frame: From surgical incision to 7 days postoperative]

Prothrombin Time (PT) [Time Frame: From surgical incision to 7 days postoperative]

Activated Partial Thromboplastin Time (aPTT) [Time Frame: From surgical incision to 7 days postoperative]

Endogenous Thrombin Potential (Thrombin generation assay (CAT)) [Time Frame: From surgical incision to 7 days postoperative]

Lag Time (Thrombin generation assay (CAT)) [Time Frame: From surgical incision to 7 days postoperative]

Time-to-Thrombin Peak (Thrombin generation assay (CAT)) [Time Frame: From surgical incision to 7 days postoperative]

Thrombin Peak (TP) (Thrombin generation assay (CAT)) [Time Frame: From surgical incision to 7 days postoperative]

P-selectin expression (Platelet activation test (PACT)) [Time Frame: From surgical incision to 7 days postoperative]

αIIbβ3 activation (Platelet activation test (PACT)) [Time Frame: From surgical incision to 7 days postoperative]

A5 EXTEM (Rotational thromboelastometry (ROTEM)) [Time Frame: From surgical incision to 7 days postoperative]

A5 FIBTEM (Rotational thromboelastometry (ROTEM)) [Time Frame: From surgical incision to 7 days postoperative]

A5 HEPTEM (Rotational thromboelastometry (ROTEM)) [Time Frame: From surgical incision to 7 days postoperative]

A30 EXTEM (Rotational thromboelastometry (ROTEM)) [Time Frame: From surgical incision to 7 days postoperative]

A30 FIBTEM (Rotational thromboelastometry (ROTEM)) [Time Frame: From surgical incision to 7 days postoperative]

A30 HEPTEM (Rotational thromboelastometry (ROTEM)) [Time Frame: From surgical incision to 7 days postoperative]

Alpha EXTEM (Rotational thromboelastometry (ROTEM)) [Time Frame: From surgical incision to 7 days postoperative]

Alpha FIBTEM (Rotational thromboelastometry (ROTEM)) [Time Frame: From surgical incision to 7 days postoperative]

Alpha HEPTEM (Rotational thromboelastometry (ROTEM)) [Time Frame: From surgical incision to 7 days postoperative]

Coagulation Time CT EXTEM (Rotational thromboelastometry (ROTEM)) [Time Frame: From surgical incision to 7 days postoperative]

Coagulation Time CT FIBTEM (Rotational thromboelastometry (ROTEM)) [Time Frame: From surgical incision to 7 days postoperative]

Coagulation Time CT HEPTEM (Rotational thromboelastometry (ROTEM)) [Time Frame: From surgical incision to 7 days postoperative]

Clot Formation Time CFT EXTEM (Rotational thromboelastometry (ROTEM) [Time Frame: From surgical incision to 7 days postoperative]

Clot Formation Time CFT FIBTEM (Rotational thromboelastometry (ROTEM) [Time Frame: From surgical incision to 7 days postoperative]

Clot Formation Time CFT HEPTEM (Rotational thromboelastometry (ROTEM) [Time Frame: From surgical incision to 7 days postoperative]

Maximum Lysis (ML) EXTEM Rotational thromboelastometry (ROTEM) [Time Frame: From surgical incision to 7 days postoperative]

Maximum Lysis (ML) FIBTEM Rotational thromboelastometry (ROTEM) [Time Frame: From surgical incision to 7 days postoperative]

Maximum Lysis (ML) HEPTEM Rotational thromboelastometry (ROTEM) [Time Frame: From surgical incision to 7 days postoperative]

Descriptive Information
PhaseN/A
Study TypeObservational
Condition
  • Mesothelioma; Peritoneum
  • Pseudomyxoma Peritonei
  • Peritoneal Carcinomatosis
Intervention
  • Procedure: CRS/HIPEC
Study Arms / Comparison Groups0 / 1
Detailed Description

The purpose of this study was to quantitatively assess the impact of CRS and HIPEC, on various components of hemostasis. Routine laboratory assays such as activated clotting time, activated partial thromboplastin time, prothrombin time, or platelet count might, as demonstrated previously, insufficiently provide specificity and/or sensitivity to assess coagulation and platelet disorders. Therefore, additionally thrombin generation (TG) was analyzed by the calibrated automated thrombogram assay (CAT). Also, platelet function was quantitatively assessed by the PAC-t-UB assay and rotational thromboelastometry (ROTEM) was used to elucidate the contribution of platelets, intrinsic and extrinsic coagulation pathways in peri-operative bleeding. The hypothesis of this study was that the procedure exposed an increased thrombotic risk, resulting in a faster and increased TG and hyper platelet function?

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment27
GenderAll
AgesN/A - 80 Years
Accepts Healthy VolunteersNo
Eligibility Criteria

Inclusion Criteria:

- a confirmed histological diagnosis of peritoneal disease (e.g., mesothelioma; pseudomyxoma peritonei; colorectal, ovarian, or gastric peritoneal carcinomatosis of colorectal, ovarian, or gastric cancer origin; or abdominal sarcomatosis); and

- age <80 years; and

- a cardiac, renal, hepatic, and bone marrow function compatible with surgery; and

- informed written consent to participate in the study

Exclusion Criteria:(or)

- inherited coagulation abnormalities,

- active systemic infections,

- interstitial lung disease,

- serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure, uncontrolled hypertension (diastolic blood pressure constantly >100 mm Hg, systolic blood pressure constantly > 180 mm Hg).

- inadequate bone marrow function at the beginning of the trial, defined as platelet count less than <150 GPT/L or neutrophil granulocyte count less than <1.5 GPT/L.

- inadequate renal function at the beginning of the trial, defined as GFR less than <60 ml/min,

- inadequate liver function at the beginning of the trial, defined as bilirubin >1.5 times ULN (upper limit of normal), active hepatitis B or C infection,

- female patients who are pregnant or breast feeding

- participation in another therapeutic clinical trial.

Administrative Information
NCTIDNCT03034850
Responsible Party,
SponsorZiekenhuis Oost-Limburg
Verification DateJanuary 2017
Mesothelioma Doctors by State
  • Trust Funds Set Aside
  • VA Benefits Available
  • Delivered within 24 hrs

Yes   No

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